Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, radiation oncologists, surgeons and other allied healthcare professionals involved in the treatment of breast cancer. 

LEARNING OBJECTIVES

• Appreciate the incidence and clinical implications of ESR1 mutations in endocrine-resistant metastatic breast cancer (mBC), and determine optimal strategies to effectively identify patients harboring these abnormalities.
• Understand the biological rationale for, mechanism of action of and pharmacologic similarities and differences between available and investigational oral selective estrogen receptor degraders (SERDs).
• Interrogate published research documenting the efficacy of oral SERD monotherapy for ER-positive, HER2-negative, ESR1-mutated mBC progressing on standard endocrine therapy in combination with a CDK4/6 inhibitor to optimally integrate these agents into the care of appropriately selected patients.
• Review available research data evaluating the role of serial ESR1 testing using circulating tumor DNA as a means to inform early therapeutic switching for patients with hormone receptor-positive mBC receiving CDK4/6 inhibitor-based first-line therapy, and consider the potential role of this novel strategy in treatment.
• Evaluate available clinical trial data with oral SERDs in combination with other systemic therapies (eg, CDK4/6 inhibitors, mTOR inhibitors), and consider the potential role of these regimens in disease management.
• Appreciate side effects associated with available and investigational oral SERDs, and use this information to develop supportive care plans for patients undergoing treatment with this form of therapy.
• Assess ongoing clinical research studies evaluating novel applications of oral SERDs for ER-positive breast cancer, and counsel patients regarding the potential benefits of trial participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.25 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology. 

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, this program has been specifically designed for the following ABS practice area: complex general surgical oncology. 

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/YIR2025/OralSERDsBreast/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Aditya Bardia, MD, MPH
Program Director, Breast Medical Oncology
Assistant Chief (Translational Research)
Division of Hematology-Oncology
Director of Translational Research Integration
UCLA Health Jonsson Comprehensive Cancer Center
Professor of Medicine, Geffen School of Medicine
University of California Los Angeles
Los Angeles, California

Consulting Agreements: Alyssum Therapeutics, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Merck, Novartis, Pfizer Inc, Vyome; Contracted Research (Support to Institution): AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Merck, Novartis, OnKure Therapeutics, Pfizer Inc.

Erica Mayer, MD, MPH, FASCO
Director of Breast Cancer Clinical Research
Breast Oncology Center
Dana-Farber Cancer Institute
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Aktis Oncology, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Lilly, Novartis.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics Inc.

Release date: April 2026
Expiration date: April 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Baird RD et al. Camizestrant in combination with three globally approved CDK4/6 inhibitors in women with ER+, HER2- advanced breast cancer: Results from SERENA-1. Clin Cancer Res 2025;31(20):4244-54. Abstract

Bardia A et al. Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global phase III lidERA Breast Cancer trial. San Antonio Breast Cancer Symposium 2025;Abstract GS1-10.

Basu GD et al. Characterization of ESR1 alterations in patients with breast and gynecologic cancers. Breast Cancer Res 2026;28(1):40. Abstract

Bidard F et al. Updated results and an exploratory analysis of ESR1m circulating tumor DNA (ctDNA) dynamics from SERENA-6, a phase 3 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1 mutations (ESR1m) during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2- advanced breast cancer (ABC). San Antonio Breast Cancer Symposium 2025;Abstract RF7-03.

Cabel L et al. Kinetics and determinants of ESR1 mutation detection in metastatic breast cancer. Ann Oncol 2026;37(3):329-40. Abstract

Jhaveri KL et al. Imlunestrant with or without abemaciclib in advanced breast cancer: Updated efficacy results from the phase III EMBER-3 trial Imlunestrant with or without abemaciclib in advanced breast cancer: Updated efficacy results from the phase III EMBER-3 trial. Ann Oncol 2026;37(4):532-43. Abstract

Lloyd MR et al. Clinical and genomic factors associated with elacestrant outcomes in ESR1-mutant metastatic breast cancer. Clin Cancer Res 2026;32(1):169-78. Abstract

Manich CS et al. Imlunestrant (Imlu) with or without abemaciclib (Abema) in advanced breast cancer (ABC): A subgroup analysis in CDK4/6 inhibitor (CDK4/6i)-pretreated patients (pts) from EMBER-3. ESMO Breast 2025;Abstract 297O.

Mayer E et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial. ESMO 2025;Abstract LBA16.

Neven P et al. Imlunestrant with or without abemaciclib as first- and second-line therapy in advanced breast cancer (ABC): A subgroup analysis from the EMBER-3 trial. ESMO Breast 2025;Abstract 306P.

O’Shaughnessy J et al. Imlunestrant with or without abemaciclib in advanced breast cancer (ABC): Safety analyses from the phase III EMBER-3 trial. ASCO 2025;Abstract 1060.

Robertson JFR et al. Pharmacodynamics of camizestrant treatment in postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer: Results from the randomized, presurgical SERENA-3 study. J Clin Oncol 2026;44(9):750-61. Abstract

Rugo H et al. Elacestrant in combination with everolimus or abemaciclib in patients with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Phase 2 results from ELEVATE, an open-label, umbrella study. San Antonio Breast Cancer Symposium 2025;Abstract RF7-01.

Rugo HS et al. Real-world outcomes of elacestrant in ER+, HER2-, ESR1-mutant metastatic breast cancer. Clin Cancer Res 2026;32(1):179-87. Abstract

Rugo HS et al. Clinical and biomarker subgroup analysis of evERA Breast Cancer: A phase III trial of giredestrant plus everolimus in patients with estrogen receptor-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor. San Antonio Breast Cancer Symposium 2025;Abstract GS3-09.

Vidal M et al. Elacestrant in women with estrogen receptor-positive and HER2-negative early breast cancer: Results from the preoperative window-of-opportunity ELIPSE trial. Clin Cancer Res 2025;31(7):1223-32. Abstract

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, radiation oncologists, surgeons and other allied healthcare professionals involved in the treatment of breast cancer. 

LEARNING OBJECTIVES

• Appreciate the incidence and clinical implications of ESR1 mutations in endocrine-resistant metastatic breast cancer (mBC), and determine optimal strategies to effectively identify patients harboring these abnormalities.
• Understand the biological rationale for, mechanism of action of and pharmacologic similarities and differences between available and investigational oral selective estrogen receptor degraders (SERDs).
• Interrogate published research documenting the efficacy of oral SERD monotherapy for ER-positive, HER2-negative, ESR1-mutated mBC progressing on standard endocrine therapy in combination with a CDK4/6 inhibitor to optimally integrate these agents into the care of appropriately selected patients.
• Review available research data evaluating the role of serial ESR1 testing using circulating tumor DNA as a means to inform early therapeutic switching for patients with hormone receptor-positive mBC receiving CDK4/6 inhibitor-based first-line therapy, and consider the potential role of this novel strategy in treatment.
• Evaluate available clinical trial data with oral SERDs in combination with other systemic therapies (eg, CDK4/6 inhibitors, mTOR inhibitors), and consider the potential role of these regimens in disease management.
• Appreciate side effects associated with available and investigational oral SERDs, and use this information to develop supportive care plans for patients undergoing treatment with this form of therapy.
• Assess ongoing clinical research studies evaluating novel applications of oral SERDs for ER-positive breast cancer, and counsel patients regarding the potential benefits of trial participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activitiy, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.25 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY

This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/YIR2025/OralSERDsBreast/Presentations/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Aditya Bardia, MD, MPH
Program Director, Breast Medical Oncology
Assistant Chief (Translational Research)
Division of Hematology-Oncology
Director of Translational Research Integration
UCLA Health Jonsson Comprehensive Cancer Center
Professor of Medicine, Geffen School of Medicine
University of California Los Angeles
Los Angeles, California

Consulting Agreements: Alyssum Therapeutics, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Merck, Novartis, Pfizer Inc, Vyome; Contracted Research (Support to Institution): AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Merck, Novartis, OnKure Therapeutics, Pfizer Inc.

Erica Mayer, MD, MPH, FASCO
Director of Breast Cancer Clinical Research
Breast Oncology Center
Dana-Farber Cancer Institute
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Aktis Oncology, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Lilly, Novartis.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics Inc.

Release date: April 2026
Expiration date: April 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Baird RD et al. Camizestrant in combination with three globally approved CDK4/6 inhibitors in women with ER+, HER2- advanced breast cancer: Results from SERENA-1. Clin Cancer Res 2025;31(20):4244-54. Abstract

Bardia A et al. Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global phase III lidERA Breast Cancer trial. San Antonio Breast Cancer Symposium 2025;Abstract GS1-10.

Basu GD et al. Characterization of ESR1 alterations in patients with breast and gynecologic cancers. Breast Cancer Res 2026;28(1):40. Abstract

Bidard F et al. Updated results and an exploratory analysis of ESR1m circulating tumor DNA (ctDNA) dynamics from SERENA-6, a phase 3 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1 mutations (ESR1m) during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2- advanced breast cancer (ABC). San Antonio Breast Cancer Symposium 2025;Abstract RF7-03.

Cabel L et al. Kinetics and determinants of ESR1 mutation detection in metastatic breast cancer. Ann Oncol 2026;37(3):329-40. Abstract

Jhaveri KL et al. Imlunestrant with or without abemaciclib in advanced breast cancer: Updated efficacy results from the phase III EMBER-3 trial Imlunestrant with or without abemaciclib in advanced breast cancer: Updated efficacy results from the phase III EMBER-3 trial. Ann Oncol 2026;37(4):532-43. Abstract

Lloyd MR et al. Clinical and genomic factors associated with elacestrant outcomes in ESR1-mutant metastatic breast cancer. Clin Cancer Res 2026;32(1):169-78. Abstract

Manich CS et al. Imlunestrant (Imlu) with or without abemaciclib (Abema) in advanced breast cancer (ABC): A subgroup analysis in CDK4/6 inhibitor (CDK4/6i)-pretreated patients (pts) from EMBER-3. ESMO Breast 2025;Abstract 297O.

Mayer E et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial. ESMO 2025;Abstract LBA16.

Neven P et al. Imlunestrant with or without abemaciclib as first- and second-line therapy in advanced breast cancer (ABC): A subgroup analysis from the EMBER-3 trial. ESMO Breast 2025;Abstract 306P.

O’Shaughnessy J et al. Imlunestrant with or without abemaciclib in advanced breast cancer (ABC): Safety analyses from the phase III EMBER-3 trial. ASCO 2025;Abstract 1060.

Robertson JFR et al. Pharmacodynamics of camizestrant treatment in postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer: Results from the randomized, presurgical SERENA-3 study. J Clin Oncol 2026;44(9):750-61. Abstract

Rugo H et al. Elacestrant in combination with everolimus or abemaciclib in patients with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Phase 2 results from ELEVATE, an open-label, umbrella study. San Antonio Breast Cancer Symposium 2025;Abstract RF7-01.

Rugo HS et al. Real-world outcomes of elacestrant in ER+, HER2-, ESR1-mutant metastatic breast cancer. Clin Cancer Res 2026;32(1):179-87. Abstract

Rugo HS et al. Clinical and biomarker subgroup analysis of evERA Breast Cancer: A phase III trial of giredestrant plus everolimus in patients with estrogen receptor-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor. San Antonio Breast Cancer Symposium 2025;Abstract GS3-09.

Vidal M et al. Elacestrant in women with estrogen receptor-positive and HER2-negative early breast cancer: Results from the preoperative window-of-opportunity ELIPSE trial. Clin Cancer Res 2025;31(7):1223-32. Abstract

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows, radiation oncologists, surgeons and other allied healthcare professionals involved in the treatment of breast cancer. 

LEARNING OBJECTIVES

• Appreciate the incidence and clinical implications of ESR1 mutations in endocrine-resistant metastatic breast cancer (mBC), and determine optimal strategies to effectively identify patients harboring these abnormalities.
• Understand the biological rationale for, mechanism of action of and pharmacologic similarities and differences between available and investigational oral selective estrogen receptor degraders (SERDs).
• Interrogate published research documenting the efficacy of oral SERD monotherapy for ER-positive, HER2-negative, ESR1-mutated mBC progressing on standard endocrine therapy in combination with a CDK4/6 inhibitor to optimally integrate these agents into the care of appropriately selected patients.
• Review available research data evaluating the role of serial ESR1 testing using circulating tumor DNA as a means to inform early therapeutic switching for patients with hormone receptor-positive mBC receiving CDK4/6 inhibitor-based first-line therapy, and consider the potential role of this novel strategy in treatment.
• Evaluate available clinical trial data with oral SERDs in combination with other systemic therapies (eg, CDK4/6 inhibitors, mTOR inhibitors), and consider the potential role of these regimens in disease management.
• Appreciate side effects associated with available and investigational oral SERDs, and use this information to develop supportive care plans for patients undergoing treatment with this form of therapy.
• Assess ongoing clinical research studies evaluating novel applications of oral SERDs for ER-positive breast cancer, and counsel patients regarding the potential benefits of trial participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activitiy, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.25 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology. 

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, this program has been specifically designed for the following ABS practice area: complex general surgical oncology. 

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY

This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/YIR2025/OralSERDsBreast/Presentations/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Aditya Bardia, MD, MPH
Program Director, Breast Medical Oncology
Assistant Chief (Translational Research)
Division of Hematology-Oncology
Director of Translational Research Integration
UCLA Health Jonsson Comprehensive Cancer Center
Professor of Medicine, Geffen School of Medicine
University of California Los Angeles
Los Angeles, California

Consulting Agreements: Alyssum Therapeutics, AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Merck, Novartis, Pfizer Inc, Vyome; Contracted Research (Support to Institution): AstraZeneca Pharmaceuticals LP, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Lilly, Menarini Group, Merck, Novartis, OnKure Therapeutics, Pfizer Inc.

Erica Mayer, MD, MPH, FASCO
Director of Breast Cancer Clinical Research
Breast Oncology Center
Dana-Farber Cancer Institute
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: Aktis Oncology, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Lilly, Novartis.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from Genentech, a member of the Roche Group, Lilly, and Stemline Therapeutics Inc.

Release date: April 2026
Expiration date: April 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Baird RD et al. Camizestrant in combination with three globally approved CDK4/6 inhibitors in women with ER+, HER2- advanced breast cancer: Results from SERENA-1. Clin Cancer Res 2025;31(20):4244-54. Abstract

Bardia A et al. Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global phase III lidERA Breast Cancer trial. San Antonio Breast Cancer Symposium 2025;Abstract GS1-10.

Basu GD et al. Characterization of ESR1 alterations in patients with breast and gynecologic cancers. Breast Cancer Res 2026;28(1):40. Abstract

Bidard F et al. Updated results and an exploratory analysis of ESR1m circulating tumor DNA (ctDNA) dynamics from SERENA-6, a phase 3 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1 mutations (ESR1m) during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2- advanced breast cancer (ABC). San Antonio Breast Cancer Symposium 2025;Abstract RF7-03.

Cabel L et al. Kinetics and determinants of ESR1 mutation detection in metastatic breast cancer. Ann Oncol 2026;37(3):329-40. Abstract

Jhaveri KL et al. Imlunestrant with or without abemaciclib in advanced breast cancer: Updated efficacy results from the phase III EMBER-3 trial Imlunestrant with or without abemaciclib in advanced breast cancer: Updated efficacy results from the phase III EMBER-3 trial. Ann Oncol 2026;37(4):532-43. Abstract

Lloyd MR et al. Clinical and genomic factors associated with elacestrant outcomes in ESR1-mutant metastatic breast cancer. Clin Cancer Res 2026;32(1):169-78. Abstract

Manich CS et al. Imlunestrant (Imlu) with or without abemaciclib (Abema) in advanced breast cancer (ABC): A subgroup analysis in CDK4/6 inhibitor (CDK4/6i)-pretreated patients (pts) from EMBER-3. ESMO Breast 2025;Abstract 297O.

Mayer E et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the phase III evERA BC trial. ESMO 2025;Abstract LBA16.

Neven P et al. Imlunestrant with or without abemaciclib as first- and second-line therapy in advanced breast cancer (ABC): A subgroup analysis from the EMBER-3 trial. ESMO Breast 2025;Abstract 306P.

O’Shaughnessy J et al. Imlunestrant with or without abemaciclib in advanced breast cancer (ABC): Safety analyses from the phase III EMBER-3 trial. ASCO 2025;Abstract 1060.

Robertson JFR et al. Pharmacodynamics of camizestrant treatment in postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer: Results from the randomized, presurgical SERENA-3 study. J Clin Oncol 2026;44(9):750-61. Abstract

Rugo H et al. Elacestrant in combination with everolimus or abemaciclib in patients with ER+/HER2- locally advanced or metastatic breast cancer (mBC): Phase 2 results from ELEVATE, an open-label, umbrella study. San Antonio Breast Cancer Symposium 2025;Abstract RF7-01.

Rugo HS et al. Real-world outcomes of elacestrant in ER+, HER2-, ESR1-mutant metastatic breast cancer. Clin Cancer Res 2026;32(1):179-87. Abstract

Rugo HS et al. Clinical and biomarker subgroup analysis of evERA Breast Cancer: A phase III trial of giredestrant plus everolimus in patients with estrogen receptor-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor. San Antonio Breast Cancer Symposium 2025;Abstract GS3-09.

Vidal M et al. Elacestrant in women with estrogen receptor-positive and HER2-negative early breast cancer: Results from the preoperative window-of-opportunity ELIPSE trial. Clin Cancer Res 2025;31(7):1223-32. Abstract

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematology-oncology fellows, surgeons and other healthcare providers involved in the treatment of colorectal cancer (CRC).

LEARNING OBJECTIVES

• Understand the incidence and prognostic and clinical relevance of microsatellite instability (MSI)/mismatch repair (MMR) deficiency in patients with localized colorectal cancer (CRC), and consider the implications for molecular testing and care.
• Evaluate the biological rationale for the use of immune checkpoint inhibitors in the care of patients with localized MSI-high (MSI-H)/MMR-deficient (dMMR) CRC, and provide counsel regarding available clinical evidence and guideline-endorsed treatment recommendations.
• Optimize the current and future use of neoadjuvant therapy for patients with localized and locally advanced CRC, considering the influence of various clinical and biological factors, including MSI/MMR status.
• Appreciate published research documenting the efficacy and safety of anti-PD-1/PD-L1 antibody therapy added to standard adjuvant chemotherapy for Stage III MSI-H/dMMR colon cancer, and counsel patients regarding the potential role of this novel therapeutic approach.
• Recognize the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker in CRC, and comprehend the rationale for its use in detecting molecular residual disease in patients.
• Appreciate published datasets documenting the clinical utility of ctDNA testing in risk stratification, surveillance and treatment decision-making for patients with CRC, and consider the current and future role of this strategy in personalizing treatment.
• Recall ongoing trials evaluating novel agents and strategies for patients with nonmetastatic CRC, and use this information to refer candidates for study participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Proceedings: Research To Practice designates this enduring material for a maximum of 1.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 1.75 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/ASCOGI26/LocalizedCRC/Video/CME

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Stacey A Cohen, MD
Professor
Fred Hutchinson Cancer Center
University of Washington
Seattle, Washington

Advisory Committees: AbbVie Inc, Agenus Inc, Caris Life Sciences, DoMore Diagnostics, Exact Sciences Corporation, Guardant Health, Incyte Corporation, Janssen Biotech Inc, Merck, Pfizer Inc, Roche Laboratories Inc; Data and Safety Monitoring Boards/Committees: GSK.

Jenny Seligmann, MBChB, PhD
Professor of Gastrointestinal Cancer
University of Leeds
Leeds, United Kingdom

No relevant financial relationships to disclose.

MODERATOR
Christopher Lieu, MD
Professor of Medicine
Associate Director for Clinical Research
Director, GI Medical Oncology
University of Colorado Cancer Center
Aurora, Colorado

Consulting Agreements (to Institution): Pfizer Inc; Contracted Research (All to Institution): Genentech, a member of the Roche Group, Janssen Biotech Inc, Sanofi.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from Genentech, a member of the Roche Group, GSK, and Natera Inc.

Release date: February 2026
Expiration date: February 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Seligmann

André T et al. Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): A randomised, open-label, phase 3 trial. Lancet 2025;405(10476):383-95. Abstract

Cercek A et al. A phase two, single-arm, open-label study with dostarlimab monotherapy in participants with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (AZUR-1). Clin Colorectal Cancer 2025;24(2):325-30. Abstract

Cercek A et al. Nonoperative management of mismatch repair-deficient tumors. N Engl J Med 2025;392(23):2297-308. Abstract

Chalabi M et al. Neoadjuvant immunotherapy leads to pathological responses in MMR-proficient and MMR-deficient early-stage colon cancers. Nat Med 2020;26(4):566-76. Abstract

Kasi PM et al. Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): Interim analysis of BESPOKE CRC study. Gastrointestinal Cancers Symposium 2024;Abstract 9.

Morton D et al. Preoperative chemotherapy for operable colon cancer: Mature results of an international randomized controlled trial. J Clin Oncol 2023;41(8):1541-52. Abstract

Ochiai K et al. Total neoadjuvant therapy for rectal cancer: Which regimens to use? Cancers (Basel) 2024;16(11):2093. Abstract

Sassun R et al. Oncological outcomes of neoadjuvant chemotherapy versus upfront surgery in locally advanced colon cancer: A systematic review, meta-analysis, and sequential analysis. Ann Surg Oncol 2025;32(9):6720-7. Abstract

Seligmann J et al. Comparison of outcomes in clinical trials of locally advanced dMMR colon cancer: FOxTROT and NICHE-2. ESMO 2025;Abstract 724O.

Dr Lieu

André T et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol 2009;27(19):3109-16. Abstract

Courneya KS et al. Structured exercise after adjuvant chemotherapy for colon cancer. N Engl J Med 2025;393(1):13-25. Abstract

Martling A et al. Low-dose aspirin for PI3K-altered localized colorectal cancer. N Engl J Med 2025;393(11):1051-64. Abstract

Rasschaert G et al. AZUR-4, a phase 2, open label, randomized study of neoadjuvant dostarlimab plus capecitabine plus oxaliplatin (CAPEOX) versus CAPEOX alone in previously untreated T4N0 or stage III mismatch repair proficient/microsatellite stable resectable colon cancer. ASCO 2025;Abstract TPS3649.

Sargent DJ et al. Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer. J Clin Oncol 2010;28(20):3219-26. Abstract

Sinicrope FA et al. Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502; ATOMIC). ASCO 2025;Abstract LBA1.

Dr Cohen

Bando H et al. A randomized, double-blind, phase III study comparing trifluridine/tipiracil (FTD/TPI) versus placebo in patients with molecular residual disease following curative resection of colorectal cancer (CRC): The ALTAIR study. Gastrointestinal Cancers Symposium 2025;Abstract LBA22.

Cohen SA et al. Practical recommendations for using ctDNA in clinical decision making. Nature 2023;619(7969):259-68. Abstract

Dasari A et al. Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA): NRG-GI008. ASCO 2025;Abstract TPS3644.

Dasari A et al. Subgroup analyses of safety and efficacy by number and types of prior lines of treatment in FRESCO-2, a global phase III study of fruquintinib in patients with refractory metastatic colorectal cancer. ASCO 2023;Abstract 3604.

Dasari A et al. ctDNA applications and integration in colorectal cancer: An NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol 2020;17(12):757-70. Abstract

Gianni C et al. Cell-free DNA fragmentomics: A promising biomarker for diagnosis, prognosis and prediction of response in breast cancer. Int J Mol Sci 2022;23(22):14197. Abstract

Kasi PM et al. Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): Interim analysis of BESPOKE CRC study. Gastrointestinal Cancers Symposium 2024;Abstract 9.

Kotaka M et al. Association of circulating tumor DNA dynamics with clinical outcomes in the adjuvant setting for patients with colorectal cancer from an observational GALAXY study in CIRCULATE-Japan. Gastrointestinal Cancers Symposium 2022;Abstract 9.

Maddalena G et al. INTERCEPT Program of circulating tumor DNA (ctDNA) testing for minimal residual disease (MRD) in colorectal cancer (CRC): Results from a prospective clinical cohort. Gastrointestinal Cancers Symposium 2024;Abstract 27.

Morris VK et al. Phase II results of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA) phase II/III study. Gastrointestinal Cancers Symposium 2024;Abstract 5.

Nakamura Y et al. ctDNA-based molecular residual disease and survival in resectable colorectal cancer. Nat Med 2024;30(11):3272-83. Abstract

Nowak JA et al. Prognostic and predictive role of circulating tumor DNA (ctDNA) in stage III colon cancer treated with celecoxib: Findings from CALGB (Alliance)/SWOG 80702. Gastrointestinal Cancers Symposium 2025;Abstract LBA14.

Parikh AR et al. Minimal residual disease detection using a plasma-only circulating tumor DNA assay in patients with colorectal cancer. Clin Cancer Res 2021;27(20):5586-94. Abstract

Rolfo C, Russo A. Liquid biopsy for early stage lung cancer moves ever closer. Nat Rev Clin Oncol 2020;17(9):523-4. Abstract

Shah PK et al. Circulating tumor DNA for detection of molecular residual disease (MRD) in patients (pts) with stage II/III colorectal cancer (CRC): Final analysis of the BESPOKE CRC sub-cohort. Gastrointestinal Cancers Symposium 2025;Abstract 15.

Tie J et al. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: 5-year outcomes of the randomized DYNAMIC trial. Nat Med 2025;31(5):1509-18. Abstract

Tie J et al. Circulating tumor DNA-guided adjuvant therapy in locally advanced colon cancer: The randomized phase 2/3 DYNAMIC-III trial. Nat Med 2025;31(12):4291-300. Abstract

Tie J et al. ctDNA-guided adjuvant chemotherapy escalation in stage III colon cancer: Primary analysis of the ctDNA-positive cohort from the randomized AGITG dynamic-III trial (intergroup study of AGITG and CCTG). ASCO 2025;Abstract 3503.

Tie J et al. Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: Overall survival and updated 5-year results from the randomized DYNAMIC trial. ASCO 2024;Abstract 108.

Zhang GQ et al. Predictive role of circulating tumor DNA in stage III colon cancer treated with celecoxib: A post hoc analysis of the CALGB (Alliance)/SWOG 80702 phase 3 randomized clinical trial. JAMA Oncol 2025:e255144. Abstract

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows and other allied healthcare professionals involved in the treatment of chronic lymphocytic leukemia.

LEARNING OBJECTIVES

• Appraise available Phase III data documenting the comparative efficacy and tolerability of first- and second-generation Bruton tyrosine kinase (BTK) inhibitors, and consider the implications of these findings for clinical decision-making for patients with newly diagnosed chronic lymphocytic leukemia (CLL).
• Appreciate the scientific rationale for the investigation of combined BTK and Bcl-2 inhibition, and review recently presented data documenting the safety and efficacy of this strategy for patients with CLL.
• Discuss available clinical research demonstrating the efficacy and safety of noncovalent BTK inhibitors for CLL, and consider the current and future role of these agents for patients with newly diagnosed and relapsed/refractory disease.
• Implement a plan of care to recognize and manage side effects and toxicities associated with covalent and noncovalent BTK inhibitors commonly employed in the treatment of CLL.
• Recall ongoing research studies attempting to further define the optimal role of BTK inhibitor-based strategies in therapy for CLL, and appropriately counsel patients regarding potential clinical trial participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation component and post-tests, enables the participant to earn up to 1.25 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology and hematology. 

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. 

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Jennifer R Brown, MD, PhD
Director, CLL Center and Institute Physician
Dana-Farber Cancer Institute
Worthington and Margaret Collette Professor of Medicine in the Field of Hematologic Oncology
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Alloplex Biotherapeutics, BeOne, Bristol Myers Squibb, EcoR1 Capital LLC, Galapagos NV, Genentech, a member of the Roche Group, Grifols, InnoCare Pharma, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Magnet Biomedicine, Nurix Therapeutics Inc, Pharmacyclics LLC, an AbbVie Company; Contracted Research: BeOne, iOnctura SA, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Nagoon Therapeutics Inc; Data and Safety Monitoring Boards/Committees: Grifols; Nonrelevant Financial Relationships: UpToDate.

Wojciech Jurczak, MD, PhD
Department of Clinical Oncology
Head of Lymphoma Team
Maria Skłodowska-Curie National Research Institute of Oncology
Krakow, Poland

Advisory Committees and Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Janssen Biotech Inc, Lilly, MSD, Nurix Therapeutics Inc, Regeneron Pharmaceuticals Inc, Roche Laboratories Inc, Takeda Pharmaceutical Company Limited.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, BeOne, and Lilly.

Release date: May 2026
Expiration date: May 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Al-Sawaf O et al. Fixed-duration versus continuous targeted treatment for previously untreated chronic lymphocytic leukemia: Results from the randomized CLL17 trial. ASH 2025;Abstract 1.

Brown JR et al. Fixed-duration acalabrutinib combinations in untreated chronic lymphocytic leukemia.N Engl J Med 2025;392(8):748-62. Abstract

Davids MS et al. Phase II study of acalabrutinib, venetoclax, and obinutuzumab in a treatment-naïve chronic lymphocytic leukemia population enriched for high-risk disease. J Clin Oncol 2025;43(7):788-99. Abstract

Ghia P et al. Nemtabrutinib plus venetoclax in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: Results from the dose escalation and confirmation segment of the phase 3 BELLWAVE-010 study. ASH 2025;Abstract 2119.

Jain N et al. Pirtobrutinib, venetoclax, and obinutuzumab for patients with Richter transformation: A phase 2 trial. ASH 2025;Abstract 89.

Jain N et al. Time-limited pirtobrutinib, venetoclax, and obinutuzumab combination in first-line chronic lymphocytic leukemia. ASH 2025;Abstract 680.

Jurczak W et al. BRUIN CLL-313: Randomized phase III trial of pirtobrutinib versus bendamustine plus rituximab in untreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. J Clin Oncol 2026;44(6):466-75. Abstract

Munir T et al. Measurable residual disease-guided therapy for chronic lymphocytic leukemia. N Engl J Med 2025;393(12):1177-90. Abstract

Seymour J et al. A post hoc safety analysis of fixed-duration acalabrutinib-venetoclax combinations vs chemoimmunotherapy: Results from the phase 3 AMPLIFY trial. ASH 2025;Abstract 2118.

Shadman M et al. Zanubrutinib + venetoclax for treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), including patients with del(17p) and/or TP53 mutation and unmutated immunoglobulin heavy-chain variable status: 3-year results from SEQUOIA arm D. ASH 2025;Abstract 5669.

Sharman JP et al. Acalabrutinib-obinutuzumab improves survival vs chemoimmunotherapy in treatment-naive CLL in the 6-year follow-up of ELEVATE-TN. Blood 2025;146(11):1276-85. Abstract

Sharman JP et al. Phase III trial of pirtobrutinib versus idelalisib/rituximab or bendamustine/rituximab in covalent Bruton tyrosine kinase inhibitor-pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (BRUIN CLL-321). J Clin Oncol 2025;43(22):2538-49. Abstract

Simon F et al. Acalabrutinib treatment for older (aged ≥80 years) and/or frail patients with CLL: Primary end point analysis of the CLL-Frail trial. Blood 2025;146(26):3153-62. Abstract

Soumerai J et al. Zanubrutinib + obinutuzumab + sonrotoclax in patients with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN CLL/SLL): Initial results from an ongoing phase 1/1b study, BGB-11417-101. ASH 2025;Abstract 3890.

Swaminathan M et al. Addition of obinutuzumab after one year of combined acalabrutinib and venetoclax is safer and [more] effective than early obinutuzumab in a randomized phase II trial for treatment naïve CLL. ASH 2025;Abstract 681.

Tam C et al. Frontline treatment of sonrotoclax (BGB-11417) and zanubrutinib for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) demonstrates high undetectable minimal residual disease (uMRD) rates with favorable tolerability: Updated data from BGB-11417-101, an ongoing phase 1/1b study. ASH 2025;Abstract 3891.

Tam C et al. Long-term results of patients receiving zanubrutinib in the phase 3 ALPINE study confirm sustained benefit of zanubrutinib in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL): Up to 6 years of follow-up with the long-term extension (LTE1). ASH 2025;Abstract 2123.

Tam C et al. Sustained efficacy of zanubrutinib (zanu) vs bendamustine + rituximab (BR) in treatment (tx)-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN SLL/CLL) and continued favorable survival in non-randomized patients (pts) with del(17p): 6-year follow-up in the phase 3 SEQUOIA study. ASH 2025;Abstract2129.

Tariq B et al. Relative bioavailability, food effect, and bioequivalence studies to assess a new zanubrutinib 160-mg tablet: Results from 2 phase 1 studies in healthy volunteers. Clin Pharmacol Drug Dev 2026;15(1):e1584. Abstract

Wierda W et al. Pirtobrutinib in post-cBTKi CLL/SLL: Final update from the phase 1/2 BRUIN study with more than 5 years follow-up. ASH 2025;Abstract 2115.

Woyach J et al. Updates of R/R CLL with prior exposure to Bruton’s tyrosine kinase (BTK) inhibitor and/or Bcl-2 inhibitor in the phase 1 trial of LP-168 (rocbrutinib), a novel covalent and non-covalent BTK inhibitor. ASH 2025;Abstract 87.

Woyach JA et al. Pirtobrutinib versus ibrutinib in treatment-naïve and relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. J Clin Oncol 2026;44(6):476-85. Abstract.

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows and other allied healthcare professionals involved in the treatment of chronic lymphocytic leukemia.

LEARNING OBJECTIVES

• Appraise available Phase III data documenting the comparative efficacy and tolerability of first- and second-generation Bruton tyrosine kinase (BTK) inhibitors, and consider the implications of these findings for clinical decision-making for patients with newly diagnosed chronic lymphocytic leukemia (CLL).
• Appreciate the scientific rationale for the investigation of combined BTK and Bcl-2 inhibition, and review recently presented data documenting the safety and efficacy of this strategy for patients with CLL.
• Discuss available clinical research demonstrating the efficacy and safety of noncovalent BTK inhibitors for CLL, and consider the current and future role of these agents for patients with newly diagnosed and relapsed/refractory disease.
• Implement a plan of care to recognize and manage side effects and toxicities associated with covalent and noncovalent BTK inhibitors commonly employed in the treatment of CLL.
• Recall ongoing research studies attempting to further define the optimal role of BTK inhibitor-based strategies in therapy for CLL, and appropriately counsel patients regarding potential clinical trial participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1 Medical Knowledge MOC point in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology and hematology. 

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/YIR2025/BTKiCLL/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. 

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Jennifer R Brown, MD, PhD
Director, CLL Center and Institute Physician
Dana-Farber Cancer Institute
Worthington and Margaret Collette Professor of Medicine in the Field of Hematologic Oncology
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Alloplex Biotherapeutics, BeOne, Bristol Myers Squibb, EcoR1 Capital LLC, Galapagos NV, Genentech, a member of the Roche Group, Grifols, InnoCare Pharma, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Magnet Biomedicine, Nurix Therapeutics Inc, Pharmacyclics LLC, an AbbVie Company; Contracted Research: BeOne, iOnctura SA, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Nagoon Therapeutics Inc; Data and Safety Monitoring Boards/Committees: Grifols; Nonrelevant Financial Relationships: UpToDate.

Wojciech Jurczak, MD, PhD
Department of Clinical Oncology
Head of Lymphoma Team
Maria Skłodowska-Curie National Research Institute of Oncology
Krakow, Poland

Advisory Committees and Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Janssen Biotech Inc, Lilly, MSD, Nurix Therapeutics Inc, Regeneron Pharmaceuticals Inc, Roche Laboratories Inc, Takeda Pharmaceutical Company Limited.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, BeOne, and Lilly.

Release date: May 2026
Expiration date: May 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Al-Sawaf O et al. Fixed-duration versus continuous targeted treatment for previously untreated chronic lymphocytic leukemia: Results from the randomized CLL17 trial. ASH 2025;Abstract 1.

Brown JR et al. Fixed-duration acalabrutinib combinations in untreated chronic lymphocytic leukemia.N Engl J Med 2025;392(8):748-62. Abstract

Davids MS et al. Phase II study of acalabrutinib, venetoclax, and obinutuzumab in a treatment-naïve chronic lymphocytic leukemia population enriched for high-risk disease. J Clin Oncol 2025;43(7):788-99. Abstract

Ghia P et al. Nemtabrutinib plus venetoclax in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: Results from the dose escalation and confirmation segment of the phase 3 BELLWAVE-010 study. ASH 2025;Abstract 2119.

Jain N et al. Pirtobrutinib, venetoclax, and obinutuzumab for patients with Richter transformation: A phase 2 trial. ASH 2025;Abstract 89.

Jain N et al. Time-limited pirtobrutinib, venetoclax, and obinutuzumab combination in first-line chronic lymphocytic leukemia. ASH 2025;Abstract 680.

Jurczak W et al. BRUIN CLL-313: Randomized phase III trial of pirtobrutinib versus bendamustine plus rituximab in untreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. J Clin Oncol 2026;44(6):466-75. Abstract

Munir T et al. Measurable residual disease-guided therapy for chronic lymphocytic leukemia. N Engl J Med 2025;393(12):1177-90. Abstract

Seymour J et al. A post hoc safety analysis of fixed-duration acalabrutinib-venetoclax combinations vs chemoimmunotherapy: Results from the phase 3 AMPLIFY trial. ASH 2025;Abstract 2118.

Shadman M et al. Zanubrutinib + venetoclax for treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), including patients with del(17p) and/or TP53 mutation and unmutated immunoglobulin heavy-chain variable status: 3-year results from SEQUOIA arm D. ASH 2025;Abstract 5669.

Sharman JP et al. Acalabrutinib-obinutuzumab improves survival vs chemoimmunotherapy in treatment-naive CLL in the 6-year follow-up of ELEVATE-TN. Blood 2025;146(11):1276-85. Abstract

Sharman JP et al. Phase III trial of pirtobrutinib versus idelalisib/rituximab or bendamustine/rituximab in covalent Bruton tyrosine kinase inhibitor-pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (BRUIN CLL-321). J Clin Oncol 2025;43(22):2538-49. Abstract

Simon F et al. Acalabrutinib treatment for older (aged ≥80 years) and/or frail patients with CLL: Primary end point analysis of the CLL-Frail trial. Blood 2025;146(26):3153-62. Abstract

Soumerai J et al. Zanubrutinib + obinutuzumab + sonrotoclax in patients with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN CLL/SLL): Initial results from an ongoing phase 1/1b study, BGB-11417-101. ASH 2025;Abstract 3890.

Swaminathan M et al. Addition of obinutuzumab after one year of combined acalabrutinib and venetoclax is safer and [more] effective than early obinutuzumab in a randomized phase II trial for treatment naïve CLL. ASH 2025;Abstract 681.

Tam C et al. Frontline treatment of sonrotoclax (BGB-11417) and zanubrutinib for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) demonstrates high undetectable minimal residual disease (uMRD) rates with favorable tolerability: Updated data from BGB-11417-101, an ongoing phase 1/1b study. ASH 2025;Abstract 3891.

Tam C et al. Long-term results of patients receiving zanubrutinib in the phase 3 ALPINE study confirm sustained benefit of zanubrutinib in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL): Up to 6 years of follow-up with the long-term extension (LTE1). ASH 2025;Abstract 2123.

Tam C et al. Sustained efficacy of zanubrutinib (zanu) vs bendamustine + rituximab (BR) in treatment (tx)-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN SLL/CLL) and continued favorable survival in non-randomized patients (pts) with del(17p): 6-year follow-up in the phase 3 SEQUOIA study. ASH 2025;Abstract2129.

Tariq B et al. Relative bioavailability, food effect, and bioequivalence studies to assess a new zanubrutinib 160-mg tablet: Results from 2 phase 1 studies in healthy volunteers. Clin Pharmacol Drug Dev 2026;15(1):e1584. Abstract

Wierda W et al. Pirtobrutinib in post-cBTKi CLL/SLL: Final update from the phase 1/2 BRUIN study with more than 5 years follow-up. ASH 2025;Abstract 2115.

Woyach J et al. Updates of R/R CLL with prior exposure to Bruton’s tyrosine kinase (BTK) inhibitor and/or Bcl-2 inhibitor in the phase 1 trial of LP-168 (rocbrutinib), a novel covalent and non-covalent BTK inhibitor. ASH 2025;Abstract 87.

Woyach JA et al. Pirtobrutinib versus ibrutinib in treatment-naïve and relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. J Clin Oncol 2026;44(6):476-85. Abstract.

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematologists, hematology-oncology fellows and other allied healthcare professionals involved in the treatment of chronic lymphocytic leukemia.

LEARNING OBJECTIVES

• Appraise available Phase III data documenting the comparative efficacy and tolerability of first- and second-generation Bruton tyrosine kinase (BTK) inhibitors, and consider the implications of these findings for clinical decision-making for patients with newly diagnosed chronic lymphocytic leukemia (CLL).
• Appreciate the scientific rationale for the investigation of combined BTK and Bcl-2 inhibition, and review recently presented data documenting the safety and efficacy of this strategy for patients with CLL.
• Discuss available clinical research demonstrating the efficacy and safety of noncovalent BTK inhibitors for CLL, and consider the current and future role of these agents for patients with newly diagnosed and relapsed/refractory disease.
• Implement a plan of care to recognize and manage side effects and toxicities associated with covalent and noncovalent BTK inhibitors commonly employed in the treatment of CLL.
• Recall ongoing research studies attempting to further define the optimal role of BTK inhibitor-based strategies in therapy for CLL, and appropriately counsel patients regarding potential clinical trial participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1 Medical Knowledge MOC point in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology and hematology. 

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/YIR2025/BTKiCLL/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. 

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Jennifer R Brown, MD, PhD
Director, CLL Center and Institute Physician
Dana-Farber Cancer Institute
Worthington and Margaret Collette Professor of Medicine in the Field of Hematologic Oncology
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Alloplex Biotherapeutics, BeOne, Bristol Myers Squibb, EcoR1 Capital LLC, Galapagos NV, Genentech, a member of the Roche Group, Grifols, InnoCare Pharma, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Magnet Biomedicine, Nurix Therapeutics Inc, Pharmacyclics LLC, an AbbVie Company; Contracted Research: BeOne, iOnctura SA, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Nagoon Therapeutics Inc; Data and Safety Monitoring Boards/Committees: Grifols; Nonrelevant Financial Relationships: UpToDate.

Wojciech Jurczak, MD, PhD
Department of Clinical Oncology
Head of Lymphoma Team
Maria Skłodowska-Curie National Research Institute of Oncology
Krakow, Poland

Advisory Committees and Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, BeOne, Janssen Biotech Inc, Lilly, MSD, Nurix Therapeutics Inc, Regeneron Pharmaceuticals Inc, Roche Laboratories Inc, Takeda Pharmaceutical Company Limited.

MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from AstraZeneca Pharmaceuticals LP, BeOne, and Lilly.

Release date: May 2026
Expiration date: May 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Al-Sawaf O et al. Fixed-duration versus continuous targeted treatment for previously untreated chronic lymphocytic leukemia: Results from the randomized CLL17 trial. ASH 2025;Abstract 1.

Brown JR et al. Fixed-duration acalabrutinib combinations in untreated chronic lymphocytic leukemia.N Engl J Med 2025;392(8):748-62. Abstract

Davids MS et al. Phase II study of acalabrutinib, venetoclax, and obinutuzumab in a treatment-naïve chronic lymphocytic leukemia population enriched for high-risk disease. J Clin Oncol 2025;43(7):788-99. Abstract

Ghia P et al. Nemtabrutinib plus venetoclax in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: Results from the dose escalation and confirmation segment of the phase 3 BELLWAVE-010 study. ASH 2025;Abstract 2119.

Jain N et al. Pirtobrutinib, venetoclax, and obinutuzumab for patients with Richter transformation: A phase 2 trial. ASH 2025;Abstract 89.

Jain N et al. Time-limited pirtobrutinib, venetoclax, and obinutuzumab combination in first-line chronic lymphocytic leukemia. ASH 2025;Abstract 680.

Jurczak W et al. BRUIN CLL-313: Randomized phase III trial of pirtobrutinib versus bendamustine plus rituximab in untreated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. J Clin Oncol 2026;44(6):466-75. Abstract

Munir T et al. Measurable residual disease-guided therapy for chronic lymphocytic leukemia. N Engl J Med 2025;393(12):1177-90. Abstract

Seymour J et al. A post hoc safety analysis of fixed-duration acalabrutinib-venetoclax combinations vs chemoimmunotherapy: Results from the phase 3 AMPLIFY trial. ASH 2025;Abstract 2118.

Shadman M et al. Zanubrutinib + venetoclax for treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), including patients with del(17p) and/or TP53 mutation and unmutated immunoglobulin heavy-chain variable status: 3-year results from SEQUOIA arm D. ASH 2025;Abstract 5669.

Sharman JP et al. Acalabrutinib-obinutuzumab improves survival vs chemoimmunotherapy in treatment-naive CLL in the 6-year follow-up of ELEVATE-TN. Blood 2025;146(11):1276-85. Abstract

Sharman JP et al. Phase III trial of pirtobrutinib versus idelalisib/rituximab or bendamustine/rituximab in covalent Bruton tyrosine kinase inhibitor-pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (BRUIN CLL-321). J Clin Oncol 2025;43(22):2538-49. Abstract

Simon F et al. Acalabrutinib treatment for older (aged ≥80 years) and/or frail patients with CLL: Primary end point analysis of the CLL-Frail trial. Blood 2025;146(26):3153-62. Abstract

Soumerai J et al. Zanubrutinib + obinutuzumab + sonrotoclax in patients with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN CLL/SLL): Initial results from an ongoing phase 1/1b study, BGB-11417-101. ASH 2025;Abstract 3890.

Swaminathan M et al. Addition of obinutuzumab after one year of combined acalabrutinib and venetoclax is safer and [more] effective than early obinutuzumab in a randomized phase II trial for treatment naïve CLL. ASH 2025;Abstract 681.

Tam C et al. Frontline treatment of sonrotoclax (BGB-11417) and zanubrutinib for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) demonstrates high undetectable minimal residual disease (uMRD) rates with favorable tolerability: Updated data from BGB-11417-101, an ongoing phase 1/1b study. ASH 2025;Abstract 3891.

Tam C et al. Long-term results of patients receiving zanubrutinib in the phase 3 ALPINE study confirm sustained benefit of zanubrutinib in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (R/R CLL/SLL): Up to 6 years of follow-up with the long-term extension (LTE1). ASH 2025;Abstract 2123.

Tam C et al. Sustained efficacy of zanubrutinib (zanu) vs bendamustine + rituximab (BR) in treatment (tx)-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN SLL/CLL) and continued favorable survival in non-randomized patients (pts) with del(17p): 6-year follow-up in the phase 3 SEQUOIA study. ASH 2025;Abstract2129.

Tariq B et al. Relative bioavailability, food effect, and bioequivalence studies to assess a new zanubrutinib 160-mg tablet: Results from 2 phase 1 studies in healthy volunteers. Clin Pharmacol Drug Dev 2026;15(1):e1584. Abstract

Wierda W et al. Pirtobrutinib in post-cBTKi CLL/SLL: Final update from the phase 1/2 BRUIN study with more than 5 years follow-up. ASH 2025;Abstract 2115.

Woyach J et al. Updates of R/R CLL with prior exposure to Bruton’s tyrosine kinase (BTK) inhibitor and/or Bcl-2 inhibitor in the phase 1 trial of LP-168 (rocbrutinib), a novel covalent and non-covalent BTK inhibitor. ASH 2025;Abstract 87.

Woyach JA et al. Pirtobrutinib versus ibrutinib in treatment-naïve and relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. J Clin Oncol 2026;44(6):476-85. Abstract.

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, hematology-oncology fellows, surgeons and other healthcare providers involved in the treatment of gastroesophageal cancers.

LEARNING OBJECTIVES

• Describe published research data with immune checkpoint inhibitors alone or in combination with other systemic therapies in the management of metastatic gastric, gastroesophageal junction (GEJ) and esophageal cancers, and optimally integrate these strategies into nonresearch treatment algorithms.
• Assess available data with monoclonal antibody therapy directed at claudin 18.2 (CLDN18.2) in combination with chemotherapy as first-line treatment for patients with HER2-negative, CLDN18.2-positive gastric or GEJ cancer, and optimally incorporate this approach into management algorithms.
• Review published and emerging research findings with HER2-targeted therapies for patients with HER2-positive gastroesophageal cancers, and assess the current and future role of various agents and regimens.
• Evaluate the scientific justification for the dual targeting of PD-1 and TIGIT for patients with gastroesophageal cancers, and appreciate available data with this novel approach.
• Appreciate the rationale for, available data with and ongoing research studies evaluating novel targeted and immunotherapeutic strategies for gastroesophageal cancers to enhance clinical trial participation for appropriately identified patients.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Proceedings: Research To Practice designates this enduring material for a maximum of 2.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 2.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/ASCOGI26/ImmunoTargetedGE/Video/CME. The corresponding audio program is available as an alternative at ResearchToPractice.com/ASCOGI26/ImmunoTargetedGE.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Jaffer A Ajani, MD
Professor of Medicine
Department of Gastrointestinal Medical Oncology
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, Texas

Advisory Committees and Consulting Agreements: AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Daiichi Sankyo Inc, Gilead Sciences Inc, Henlius, Jazz Pharmaceuticals Inc, Merck, Taiho Oncology Inc, Zymeworks Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Henlius, I-Mab Biopharma, Jazz Pharmaceuticals Inc, Merck, Servier Pharmaceuticals LLC.

Rutika Mehta, MD, MPH
Associate Professor, Division of Hematology/Oncology
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York

Advisory Committees: Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, BeOne, Bristol Myers Squibb, Daiichi Sankyo Inc, Eisai Inc, Gilead Sciences Inc, GSK, Jazz Pharmaceuticals Inc, Legend Biotech; Consulting Agreements: Jazz Pharmaceuticals Inc, Lilly, Replimune; Data and Safety Monitoring Boards/Committees: Arcus Biosciences, Gilead Sciences Inc; Nonrelevant Financial Relationships: Robert A Winn Career Development Award.

John Strickler, MD
Professor of Medicine
Associate Director, Clinical Research – GI
Co-Leader, Molecular Tumor Board
Duke University
Durham, North Carolina

Advisory Committees: AbbVie Inc, Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeOne, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Cytovation ASA, Daiichi Sankyo Inc, GE Healthcare, Genentech, a member of the Roche Group, GSK, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Leap Therapeutics Inc, Lilly, Merck, Natera Inc, Pfizer Inc, Pheon Therapeutics, Quanta Therapeutics, Regeneron Pharmaceuticals Inc, Sanofi, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, Triumvira Immunologics, Xilio Therapeutics; Contracted Research: AbbVie Inc, Amgen Inc, Apollo Therapeutics, Bayer HealthCare Pharmaceuticals, BeOne, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, GSK, Leap Therapeutics Inc, Lilly, Novartis, Pfizer Inc, Quanta Therapeutics, Revolution Medicines; Data and Safety Monitoring Boards/Committees: AbbVie Inc, Johnson & Johnson; Stock Options — Private Companies: Triumvira Immunologics.

MODERATOR
Samuel J Klempner, MD
Program Director, Gastroesophageal Cancers
Tobins Family Endowed Chair in Esophagogastric Cancer
Massachusetts General Hospital
Associate Professor, Harvard Medical School
Boston, Massachusetts

Advisory Committees: Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology, Gilead Sciences Inc, I-Mab Biopharma, Merck, Mersana Therapeutics Inc, Natera Inc, Novartis, Pfizer Inc, Taiho Oncology Inc; Consulting Agreements: Astellas, Novartis (ended 2023); Stock Options — Private Companies: MBrace Therapeutics; Nonrelevant Financial Relationships: Debbie’s Dream Foundation, Degregorio Family Foundation, Gastric Cancer Foundation, Gateway for Cancer Research, National Cancer Institute/National Institutes of Health, NCCN (member of Gastric and Esophageal Guidelines Committees), Stand Up 2 Cancer/AACR, Torrey Coast Foundation.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from Astellas, BeOne, Gilead Sciences Inc, and Jazz Pharmaceuticals Inc.

Release date: January 2026
Expiration date: January 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Ajani

Elimova E et al. Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (mGEA): Primary analysis from HERIZON-GEA-01. Gastrointestinal Cancers Symposium 2026;Abstract LBA285.

Elimova E et al. Zanidatamab plus chemotherapy as first-line treatment for patients with HER2-positive advanced gastro-oesophageal adenocarcinoma: Primary results of a multicentre, single-arm, phase 2 study. Lancet Oncol 2025;26(7):847-59. Abstract

Meric-Bernstam F et al. Zanidatamab monotherapy or combined with chemotherapy in HER2-expressing gastroesophageal adenocarcinoma: A phase 1 trial. Nat Commun 2025;16(1):4293. Abstract

Shitara K et al. Trastuzumab deruxtecan or ramucirumab plus paclitaxel in gastric cancer. N Engl J Med 2025;393(4):336-48. Abstract

Dr Strickler

Ajani JA et al. Gastric cancer, version 2.2025, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw 2025;23(5):169-91. Abstract

Bray F et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2024;74(3):229-63. Abstract

Kubota Y et al. Comprehensive clinical and molecular characterization of claudin 18.2 expression in advanced gastric or gastroesophageal junction cancer. ESMO Open 2023;8(1):100762. Abstract

Shah MA et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: The randomized, phase 3 GLOW trial. Nat Med 2023;29(8):2133-41. Abstract

Shitara K et al. Phase 2 ILUSTRO trial of 1L zolbetuximab plus mFOLFOX6 and nivolumab in patients with CLDN18.2+ locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma. Gastrointestinal Cancers Symposium 2026;Abstract LBA284.

Shitara K et al. Zolbetuximab in gastric or gastroesophageal junction adenocarcinoma. N Engl J Med 2024;391(12):1159-62. Abstract

Shitara K et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): A multicentre, randomised, double-blind, phase 3 trial. Lancet 2023;401(10389):1655-68. Abstract

Dr Mehta

Janjigian YY et al. First-line nivolumab plus chemotherapy for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: 3-year follow-up of the phase III CheckMate 649 trial. J Clin Oncol 2024;42(17):2012-20. Abstract

Janjigian YY et al. Pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma: Interim analyses from the phase 3 KEYNOTE-811 randomised placebo-controlled trial. Lancet 2023;402(10418):2197-208. Abstract

Janjigian YY et al. Pembrolizumab plus trastuzumab and chemotherapy for HER2+ metastatic gastric or gastroesophageal junction (G/GEJ) cancer: Initial findings of the global phase 3 KEYNOTE-811 study. ASCO 2021;Abstract 4013.

Moehler MH et al. Rationale 305: Phase 3 study of tislelizumab plus chemotherapy vs placebo plus chemotherapy as first-line treatment (1L) of advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). Gastrointestinal Cancers Symposium 2023;Abstract 286.

Qi C et al. Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician’s choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01). ASCO 2025;Abstract 4003.

Qiu M et al. Tislelizumab (TIS) + chemotherapy (chemo) vs placebo (PBO) + chemo as first-line (1L) treatment in gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) patients with/without peritoneal or liver metastases: A post hoc analysis of RATIONALE-305 study. Gastrointestinal Cancers Symposium 2025;Abstract 414.

Qiu MZ et al. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. BMJ 2024;385:e078876. Abstract

Rha SY et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): A multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol 2023;24(11):1181-95. Abstract

Shah MA et al. Phase II study of telomelysin (OBP-301) in combination with pembrolizumab in gastroesophageal (GEA) adenocarcinoma. ASCO 2023;Abstract 4052.

Dr Klempner

Janjigian YY et al. CLARITY-Gastric 01: A randomized phase 3 study of AZD0901, a Claudin18.2 (CLDN18.2)-targeted antibody-drug conjugate, in second- or later-line (2L+) advanced gastric or gastroesophageal junction cancer (GC/GEJC). Gastrointestinal Cancers Symposium 2025;Abstract TPS507.

Janjigian YY et al. Domvanalimab and zimberelimab in advanced gastric, gastroesophageal junction or esophageal cancer: A phase 2 trial. Nat Med 2025;31(12):4274-80. Abstract

Liu JJ et al. Anti-claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients (pts) with solid tumors and gastric/gastro-esophageal junction adenocarcinoma (G/GEJ AC): A phase I study. ESMO GI 2024;Abstract 396MO.

Rivera Herrero F et al. First-line rilvegostomig (rilve) + chemotherapy (CTx) in patients (pts) with HER2-negative (HER2–) locally advanced unresectable or metastatic gastric cancers: First report of GEMINI-Gastric sub study 2. ESMO 2024;Abstract 1422P.

Shitara K et al. Global prevalence of claudin 18 isoform 2 in tumors of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Gastric Cancer 2024;27(5):1058-68. Abstract

Xu R-H et al. CLDN18.2 targeted antibody-drug conjugate (ADC), SHR-A1904, in patients (pts) with gastric/gastroesophageal junction cancer (GC/GEJC): A phase I study. ESMO 2024;Abstract 609O.