Individualizing the Selection of First-Line Therapy for Patients with Hormone Receptor-Positive Metastatic Breast Cancer: Impact of Biomarkers and Existing Comorbidities

Accreditation types: 0.75 ABIM MOC, ABS MOC, CME

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Faculty

Adam M Brufsky

Adam M Brufsky

MD, PhD

University of Pittsburgh, Pittsburgh, Pennsylvania

Professor of Medicine, UPMC Hillman Cancer Center, Department of Medicine

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of breast cancer.

LEARNING OBJECTIVES

  • Discern the mechanism by which the cyclin-dependent kinase (CDK) pathway contributes to breast cancer proliferation and growth, and consider the clinical and research implications for the management of hormone receptor (HR)-positive metastatic breast cancer (mBC).
  • Appraise published findings from randomized clinical trials and real-world experience establishing the efficacy and safety of CDK4/6 inhibitors for HR-positive mBC in order to understand the risks, benefits and optimal use of these agents in various subgroups of patients.
  • Implement a clinical plan for the treatment of newly diagnosed HR-positive mBC, considering patient age, performance status, preexisting medical conditions, prior treatments and other clinical and practical factors.
  • Develop preventive and emergent strategies to reduce or ameliorate the unique side effects associated with the various approved CDK4/6 inhibitors.

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

CREDIT DESIGNATION STATEMENT
Video Interview: 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.

Video Lecture: Research To Practice designates this enduring material for a maximum of 0.75 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 1.25 (video) and 0.75 (lecture) 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) — CONTINUOUS 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
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, review the downloadable slide set, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Interview: ResearchToPractice.com/HRPosmBCComorbidities24/Video and evaluation ResearchToPractice.com/HRPosmBCComorbidities24/Video/CME.

Video Lecture: ResearchToPractice.com/HRPosmBCComorbidities24/Presentation and evaluation ResearchToPractice.com/HRPosmBCComorbidities24/Presentation/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 conflicts of interest 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:

Adam M Brufsky, MD, PhD
Professor of Medicine
UPMC Hillman Cancer Center
Department of Medicine
University of Pittsburgh
Pittsburgh, Pennsylvania

Consulting Agreements: Agendia Inc, AstraZeneca Pharmaceuticals LP, BriaCell, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Jazz Pharmaceuticals Inc, Lilly, Merck, Myriad Genetic Laboratories Inc, Natera Inc, Novartis, Pfizer Inc, Puma Biotechnology Inc, Sanofi.

EDITOR — 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: AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, 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, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, 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 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 grantor.

These activities are supported by an educational grant from Pfizer Inc.

Release date: April 2025
Expiration date: April 2026

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

Blum JL et al. Impact of comorbidities on real-world patient-reported outcomes of patients (pts) with hormone receptor-positive human epidermal growth factor 2-negative (HR+/HER2-) advanced breast cancer (ABC) enrolled in the POLARIS trial. ESMO 2023;Abstract 461P.

Brufsky A et al. Overall survival with palbociclib (PAL) plus an aromatase inhibitor (AI) versus AI alone in older patients (pts) with de novo, HR+/HER2− metastatic breast cancer: A SEER-Medicare analysis. ASCO 2024;Abstract 1111.

Brufsky A et al. Palbociclib plus aromatase inhibitors in patients with metastatic breast cancer and cardiovascular diseases: Real-world effectiveness. Oncologist 2024;29(12):1032-43. Abstract

Brufsky A et al. Real-world comparative efficacy of CDK4/6 inhibitors in first-line treatment of HR+/HER2- metastatic breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract P2-09-30.

Brufsky A et al. Trends in HR+ metastatic breast cancer survival before and after CDK4/6 inhibitor introduction in the United States: A SEER registry analysis of patients with HER2- and HER2+ metastatic breast cancer. Breast Cancer Res Treat 2024;208(2):223-35. Abstract

Brufsky A et al. Real-world effectiveness of palbociclib plus letrozole vs letrozole alone for metastatic breast cancer with lung or liver metastases: Flatiron database analysis. Front Oncol 2022;12. Abstract

Finn RS et al. Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ER+/HER2− ABC): Analyses from PALOMA-2. ASCO 2022;Abstract LBA1003.

Llombart-Cussac A et al. PARSIFAL-LONG: Extended follow-up of hormone receptor-positive/HER2-negative advanced breast cancer patients treated with fulvestrant and palbociclib vs. letrozole and palbociclib in the PARSIFAL study. San Antonio Breast Cancer Symposium 2023;Abstract RF01-03.

Onesti CE, Jerusalem G.CDK4/6 inhibitors in breast cancer: differences in toxicity profiles and impact on agent choice. A systematic review and meta-analysis. Expert Rev Anticancer Ther 2021;21(3):283-98. Abstract

Rocque GB et al. Laboratory monitoring in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2–) advanced breast cancer treated with palbociclib in a real-world setting: Results from POLARIS. San Antonio Breast Cancer Symposium 2022;Abstract P3-01-05.

Rocque G et al. Real-world quality of life (QoL) in patients with HR+/HER2-advanced breast cancer (ABC) treated with palbociclib: Final clinical outcome assessment (COA) analysis from POLARIS. ESMO 2022;Abstract 266P.

Rugo HS et al. Comparative overall survival of CDK4/6 inhibitors plus an aromatase inhibitor in HR+/HER2- metastatic breast cancer in the US real-world setting. ESMO Open 2025;10(1):104103. Abstract

Rugo HS et al. Overall survival with first-line palbociclib plus an aromatase inhibitor (AI) vs AI in metastatic breast cancer: A large real-world database analysis. ESMO Breast Cancer 2022;Abstract 169P.

Rugo HS et al. Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2- metastatic breast cancer. NPJ Breast Cancer 2022;8(1):114. Abstract

Rugo HS et al. Real-world treatment patterns of palbociclib plus an aromatase inhibitor or aromatase inhibitor alone for metastatic breast cancer in the Flatiron database. San Antonio Breast Cancer Symposium 2022;Abstract P3-01-14.

Tripathy D et al. Characterization of neutropenia in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2–) advanced breast cancer on palbociclib in a real-world setting: Results from POLARIS. San Antonio Breast Cancer Symposium 2022;Abstract P3-01-03.

Tripathy D et al. POLARIS: A prospective, multicenter, noninterventional study assessing palbociclib in hormone receptor-positive advanced breast cancer. Future Oncol 2020;16(31):2475-85. Abstract

Optimizing the Selection of First-Line Therapy for Patients with Metastatic Non-Small Cell Lung Cancer and an ALK Rearrangement

Accreditation types: 0.75 ABIM MOC, ABS MOC, CME

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Faculty

Justin F Gainor

Justin F Gainor

MD

Massachusetts General Hospital, Boston, Massachusetts

Director, Center for Thoracic Cancers Program, Director of Targeted Immunotherapy in the Henri and Belinda Termeer Center for Targeted Therapies

Harvard Medical School, Boston, Massachusetts

Associate Professor of Medicine

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of non-small cell lung cancer.

LEARNING OBJECTIVES

  • Convey the clinical relevance of a positive ALK testing result to appropriate patients with metastatic non-small cell lung cancer (NSCLC), and establish a clinical algorithm to most effectively identify individuals harboring these abnormalities.
  • Recall available Phase III data documenting the efficacy of various ALK inhibitors as first-line therapy, and select an optimal treatment approach for newly diagnosed ALK-positive metastatic NSCLC.
  • Develop an optimal approach to the management of ALK-positive NSCLC in patients with CNS metastases, considering the implications of symptomatology, number of lesions and other relevant factors.
  • Implement a plan of care to recognize and manage the side effects and toxicities associated with approved ALK-directed therapies to support quality of life and continuation of treatment.

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

CREDIT DESIGNATION STATEMENT
Video Interview: 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.

Video Lecture: Research To Practice designates this enduring material for a maximum of 0.75 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 1.25 (video) and 0.75 (lecture) 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) — CONTINUOUS 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
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, review the downloadable slide set, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Interview: ResearchToPractice.com/FirstLineTherapyALKmNSCLC24/Video and evaluation ResearchToPractice.com/FirstLineTherapyALKmNSCLC24/Video/CME.

Video Lecture: ResearchToPractice.com/FirstLineTherapyALKmNSCLC24/Presentation and evaluation ResearchToPractice.com/FirstLineTherapyALKmNSCLC24/Presentation/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 conflicts of interest 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:

Justin F Gainor, MD
Director, Center for Thoracic Cancers Program
Director of Targeted Immunotherapy in the Henri and Belinda Termeer Center for Targeted Therapies
Massachusetts General Hospital
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Advisory Committees: AI Proteins, Amgen Inc, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Genentech, a member of the Roche Group, Gilead Sciences Inc, ITeos Therapeutics, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Mariana Oncology, Merck, Merus, Mirati Therapeutics Inc, Moderna, Novartis, Novocure Inc, Nuvalent, Pfizer Inc, Sanofi, Silverback Therapeutics, Takeda Pharmaceuticals USA Inc; Consulting Agreements: Pfizer Inc, Merck, Novartis, Takeda Pharmaceuticals USA Inc; Contracted Research: Adaptimmune, ALX Oncology, AstraZeneca Pharmaceuticals LP, Blueprint Medicines, Bristol Myers Squibb, Genentech, a member of the Roche Group, Jounce Therapeutics, Merck, Moderna, NextPoint Therapeutics, Novartis, Palleon Pharmaceuticals.

EDITOR — 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: AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, 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, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, 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 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 grantor.

These activities are supported by an educational grant from Pfizer Inc.

Release date: April 2025
Expiration date: April 2026

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

Camidge DR et al. Brigatinib versus crizotinib in ALK inhibitor-naive advanced ALK-positive NSCLC: Final results of phase 3 ALTA-1L trial. J Thorac Oncol 2021;16(12):2091-108. Abstract

Camidge DR et al. Brigatinib versus crizotinib in advanced ALK inhibitor-naive ALK-positive non-small cell lung cancer: Second interim analysis of the phase III ALTA-1L trial. J Clin Oncol 2020;38(31):3592-603. Abstract

Camidge DR et al. Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer. N Engl J Med 2018; 379(21):2027-39. Abstract

Drilon AE et al. Lorlatinib vs crizotinib in treatment-naïve patients with advanced ALK+ non-small cell lung cancer: 5-year progression-free survival and safety from the CROWN study. ASCO 2024;Abstract LBA8503.

Drilon AE et al. Phase I/II ALKOVE-1 study of NVL-655 in ALK-positive (ALK+) solid tumours. ESMO 2024;Abstract 1235O.

Gainor JF et al. Patterns of metastatic spread and mechanisms of resistance to crizotinib in ROS1-positive non-small-cell lung cancer. JCO Precis Oncol 2017;2017:PO.17.00063. Abstract

Gainor JF et al. Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer. Cancer Discov 2016;6(10):1118-33. Abstract

Hida T et al. Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): An open-label, randomised phase 3 trial. Lancet 2017; 390(10089):29-39. Abstract

Horn L et al. Ensartinib vs crizotinib for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer: A randomized clinical trial. JAMA Oncol 2021; 7(11):1617-25. Abstract

Mok T et al. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol 2020;31(8):1056-64. Abstract

Nakagawa K et al. Final progression-free survival results from the J-ALEX study of alectinib versus crizotinib in ALK-positive non-small-cell lung cancer. Lung Cancer 2020;139:195-9. Abstract

Peters S et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med 2017;377(9):829-38. Abstract

Ridker PM et al. Cardiovascular efficacy and safety of bococizumab in high-risk patients. N Engl J Med 2017;376(16):1527-39. Abstract

Schneider JL et al. ALK-positive lung cancer: A moving target. Nat Cancer 2023;4(3):330-43. Abstract

Shaw AT et al. First-line lorlatinib or crizotinib in advanced ALK-positive lung cancer. N Engl J Med 2020;383(21):2018-29. Abstract

Shaw AT et al. ALK resistance mutations and efficacy of lorlatinib in advanced anaplastic lymphoma kinase-positive non-small-cell lung cancer. J Clin Oncol 2019;37(16):1370-9. Abstract

Shiba-Ishii A et al. Analysis of lorlatinib analogs reveals a roadmap for targeting diverse compound resistance mutations in ALK-positive lung cancer. Nat Cancer 2022;3(6):710-22. Abstract

Solomon BJ et al. Efficacy and safety of first-line lorlatinib versus crizotinib in patients with advanced, ALK-positive non-small-cell lung cancer: Updated analysis of data from the phase 3, randomised, open-label CROWN study. Lancet Respir Med 2023;11(4):354-66. Abstract

Soria J-C et al. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): A randomised, open-label, phase 3 study. Lancet 2017;389(10072):917-29. Abstract

Yoshioka H et al. Final OS analysis from the phase III j-alex study of alectinib (ALC) versus crizotinib (CRZ) in Japanese ALK-inhibitor naïve ALK-positive non-small cell lung cancer (ALK+ NSCLC). ASCO 2021;Abstract 9022.

Zhou C et al. Alectinib versus crizotinib in untreated Asian patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALESIA): A randomised phase 3 study. Lancet Respir Med 2019;7(5):437-46. Abstract

New Datasets and Their Implications for Breast Cancer Management

Accreditation types: 1 ABIM MOC, ABS MOC, CME

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Faculty

Adrienne G Waks

Adrienne G Waks

MD

Dana-Farber Cancer Institute, Boston, Massachusetts

Senior Physician, Breast Medical Oncology

Harvard Medical School, Boston, Massachusetts

Assistant Professor of Medicine

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of breast cancer.

LEARNING OBJECTIVES

  • Evaluate recently presented clinical research findings to determine their effect on the current management of localized or metastatic breast cancer (mBC).
  • Evaluate updated research findings from key trials establishing the utility of genomic assays to assist in personalizing adjuvant systemic therapy for newly diagnosed hormone receptor (HR)-positive, HER2-negative breast cancer, and identify patients for whom testing results would be clinically useful.
  • Review published research data supporting the use of chemotherapy in combination with anti-PD-1/PD-L1 antibodies for patients with localized or metastatic triple-negative breast cancer (TNBC), and use this information to make appropriate treatment recommendations.
  • Appraise published efficacy and safety data from randomized trials evaluating CDK4/6 inhibitors for patients with HR-positive localized or metastatic breast cancer in order to provide appropriate counsel regarding the optimal clinical use of these agents.
  • Understand available data with and current and future clinical role of oral selective estrogen receptor degraders for patients with relapsed/refractory HR-positive mBC.
  • Evaluate published research findings to effectively inform the selection and sequencing of available therapeutic agents and regimens for patients with HER2-positive localized and metastatic breast cancer.
  • Discuss available research establishing the efficacy of PARP inhibitors in patients with localized breast cancer harboring BRCA or other homologous recombination repair pathway mutations, and identify candidates for whom treatment with these agents would be appropriate.
  • Appreciate the clinical relevance of HER2-low or HER2-ultralow mBC, and understand available research findings with HER2-directed antibody-drug conjugates (ADCs) for these patients.
  • Interrogate published Phase III research documenting the efficacy of TROP2-directed ADCs in patients with mBC to determine the current and future clinical applicability of these approaches.
  • Assess available data with novel HER3-directed therapies under development for mBC.

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

CREDIT DESIGNATION STATEMENT
Video Interview: 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.

Video Lecture: 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 these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 1.25 (video) and 1 (lecture) 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) — CONTINUOUS 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
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, review the downloadable slide set, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Interview: ResearchToPractice.com/OncologyTodayPostConf24/Breast/Video and evaluation ResearchToPractice.com/OncologyTodayPostConf24/Breast/Video/CME.

Video Lecture: ResearchToPractice.com/OncologyTodayPostConf24/Breast/Presentation and evaluation ResearchToPractice.com/OncologyTodayPostConf24/Breast/Presentation/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 conflicts of interest 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:

Adrienne G Waks, MD
Senior Physician, Breast Medical Oncology
Dana-Farber Cancer Institute
Assistant Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Advisory Committees: Ambrx; Consulting Agreements and Speakers Bureaus: AstraZeneca Pharmaceuticals LP; Contracted Research: Genentech, a member of the Roche Group, Gilead Sciences Inc, MacroGenics Inc, Merck.

EDITOR — 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: AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, 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, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, 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 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 Exact Sciences Corporation and Merck.

Release date: April 2025
Expiration date: April 2026

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

Bardia A et al. Efficacy and safety of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) by pace of disease progression on prior endocrine-based therapy: Additional analysis from DESTINY-Breast06. San Antonio Breast Cancer Symposium 2024;Abstract LB1-04.

Chen N et al. Impact of anthracyclines in high genomic risk node-negative HR+/HER2- breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS3-03.

Dent R et al. Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk, early-stage triple-negative breast cancer: Overall survival and subgroup results from the phase 3 KEYNOTE-522 study. San Antonio Breast Cancer Symposium 2024;Abstract PS12-09.

Fasching P et al. Adjuvant ribociclib (RIB) plus nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2− early breast cancer (EBC): 4-year outcomes from the NATALEE trial. ESMO 2024;Abstract LBA13.

Garber J et al. OlympiA: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients w/ germline BRCA1 & BRCA2 pathogenic variants & high-risk HER2-negative primary breast cancer: Longer term follow. San Antonio Breast Cancer Symposium 2024;Abstract GS1-09.

Geyer C et al. NSABP B-59/GBG 96-GeparDouze: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy with atezolizumab or placebo followed by adjuvant atezolizumab or placebo in patients with stage II and III triple-negative breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS3-05.

Jhaveri K et al. Imlunestrant, an oral selective estrogen receptor degrader (SERD), as monotherapy & combined with abemaciclib, for patients with ER+, HER2- advanced breast cancer (ABC), pretreated with endocrine therapy (ET): Results of the phase 3 EMBER-3 trial. San Antonio Breast Cancer Symposium 2024;Abstract GS1-01.

Kalinsky K et al. Updated results from a phase 3 randomized clinical trial in participants (pts) with 1-3 positive lymph nodes (LN), hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer (BC) with recurrence score (RS) ≤ 25 randomized to endocrine therapy (ET) +/- chemotherapy (CT): SWOG S1007 (RxPONDER). San Antonio Breast Cancer Symposium 2021;Abstract GS2-07.

Kuemmel S et al. (Neo)adjuvant nab-PAC weekly vs sb-PAC q2w, followed by EC q2w, in genomically or clinically high-risk HR+/HER- early breast cancer according to ET-response: Final survival results from the WSG ADAPT HR+/HER2- chemotherapy-trial. San Antonio Breast Cancer Symposium 2024;Abstract GS3-04.

Lin N et al. Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ advanced/metastatic breast cancer (mBC) with or without brain metastases (BM): DESTINY-Breast12 primary results. ESMO 2024;Abstract LBA18.

Loibl S et al. Primary results of the randomized phase III trial comparing first-line ET plus palbociclib vs standard mono-chemotherapy in women with high risk HER2-/HR+ metastatic breast cancer and indication for chemotherapy – PADMA study. San Antonio Breast Cancer Symposium 2024;Abstract LB1-03.

Metzger O et al. AFT-38 PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy vs anti-HER2 therapy + endocrine therapy after induction treatment for hormone receptor-positive (HR+)/HER-positive metastatic breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS2-12.

O’Shaughnessy J et al. Exploratory biomarker analysis of the phase 3 KEYNOTE-522 study of neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for early-stage TNBC. San Antonio Breast Cancer Symposium 2024;Abstract LB1-07.

Pistilli B et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy (CT) in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Final overall survival (OS) from the phase III TROPION-Breast01 trial. ESMO Virtual Plenary 2025;Abstract VP1-2025.

Pistilli B et al. Efficacy, safety and biomarker analysis of ICARUS-BREAST01: A phase II study of patritumab deruxtecan (HER3-DXd) in patients (pts) with HR+/HER2- advanced breast cancer (ABC). ESMO 2024;Abstract 340O.

Schmid P et al. Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the phase III KEYNOTE-522 study. ESMO 2024;Abstract LBA4.

Tolaney SM et al. Phase III, randomized, open-label TroFuse-010 study of sacituzumab tirumotecan (sac-TMT) alone and with pembrolizumab vs treatment of physician’s choice chemotherapy (TPC) in patients with HR+/HER2- unresectable locally advanced or metastatic breast cancer (mBC). ESMO 2024;Abstract 433TiP.

Viale G et al. Human epidermal growth factor receptor 2 (HER2)-low and HER2-ultralow status determination in tumors of patients (pts) with hormone receptor–positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06). ESMO 2024;Abstract LBA21.

Yin Y et al. Exploratory analysis of patients with or without prior PD-(L)1 inhibitors in phase III OptiTROP-Breast01 study of sacituzumab tirumotecan (sac-TMT) versus chemotherapy for previously treated advanced triple-negative breast cancer (TNBC). ESMO 2024;Abstract 386P.

Optimizing the Management of Neurofibromatosis Type 1 Plexiform Neurofibromas

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Faculty

Christopher L Moertel

Christopher L Moertel

MD

University of Minnesota, Minneapolis, Minnesota

Professor of Pediatrics, Medical Director, Pediatric Neuro-Oncology and Neurofibromatosis

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of neurofibromatosis type 1 plexiform neurofibromas.

LEARNING OBJECTIVES

  • Develop a greater understanding of the incidence, pathogenesis, natural history and common clinical manifestations of neurofibromatosis type 1 (NF1), including NF1 plexiform neurofibromas (NF1-PNs).
  • Review the current clinical management of NF1-PNs, reflecting on the advantages and disadvantages of available local and systemic treatment approaches.
  • Evaluate the biological rationale for the evaluation of MEK inhibitors for patients with NF1-PN, and recognize the pharmacologic similarities and differences between available and investigational agents in this therapeutic class.
  • Appreciate available efficacy and safety findings with MEK inhibitors for pediatric and adult patients with symptomatic, inoperable NF1-PNs, and consider the current and future role of these agents in treatment for the disease.
  • Recognize adverse events and other practical considerations associated with MEK inhibitors, and develop strategies to minimize toxicities and maximize treatment benefit.
  • Recollect other agents and strategies under evaluation for NF1-PNs, and counsel appropriately selected patients about participation in active research protocols.

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

CREDIT DESIGNATION STATEMENT
Video Interview: 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.

Video Lecture: 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 components and post-tests, enables the participant to earn up to 1 (video) and 1.25 (lecture) 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) — CONTINUOUS 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
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, review the downloadable slide set, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Interview: ResearchToPractice.com/OncologyTodayNF24/Video and evaluation ResearchToPractice.com/OncologyTodayNF24/Video/CME.

Video Lecture: ResearchToPractice.com/OncologyTodayNF24/Presentation and evaluation ResearchToPractice.com/OncologyTodayNF24/Presentation/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 conflicts of interest 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:

Christopher L Moertel, MD
Professor of Pediatrics
Medical Director, Pediatric Neuro-Oncology and Neurofibromatosis
University of Minnesota
Minneapolis, Minnesota

No relevant conflicts of interest to disclose.

EDITOR — 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: AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, 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, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, 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 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 grantor.

These activities are supported by an educational grant from SpringWorks Therapeutics Inc.

Release date: March 2025
Expiration date: March 2026

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

Gross AM et al. Selumetinib in children with inoperable plexiform neurofibromas. N Engl J Med 2020;382(15):1430-42. Abstract

Hargreave M et al. Association between maternal hormonal contraception use and central nervous system tumors in children. JAMA 2022;327(1):59-66. Abstract

Legius E et al. Revised diagnostic criteria for neurofibromatosis type 1 and Legius syndrome: An international consensus recommendation. Genet Med 2021;23(8):1506-13. Abstract

Moertel CL et al. ReNeu: A pivotal phase 2b trial of mirdametinib in children and adults with neurofibromatosis type 1 (NF1)-associated symptomatic inoperable plexiform neurofibroma (PN). ASCO 2024;Abstract 3016.

Yao C et al. Malignant peripheral nerve sheath tumors: Latest concepts in disease pathogenesis and clinical management. Cancers (Basel) 2023;15(4):1077. Abstract

Optimizing the Role of CAR T-Cell Therapy in the Management of Multiple Myeloma

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Faculty

Surbhi Sidana

Surbhi Sidana

MD

Stanford University, Stanford, California

Associate Professor of Medicine, Director, Myeloma Disease Focused Group, Associate Director of Clinical Research, Division of Blood and Marrow Transplantation and Cellular Therapy

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of multiple myeloma.

LEARNING OBJECTIVES

  • Understand the scientific rationale for and mechanism of action of BCMA-directed chimeric antigen receptor (CAR) T-cell therapy for patients with multiple myeloma (MM), and appreciate the similarities and differences among currently available agents in this class.
  • Understand the clinical research database with BCMA-directed CAR T-cell therapy for the management of relapsed/refractory MM to optimally integrate this novel therapeutic strategy into treatment sequencing algorithms.
  • Understand the pathophysiology of cytokine release syndrome and neurologic toxicities associated with CAR T-cell therapy for MM, and develop strategies to optimally identify and manage these side effects.
  • Recognize the spectrum, frequency and severity of other adverse events (eg, secondary hematologic malignancies, infections, cytopenias) associated with CAR T-cell therapy for patients with MM, and consider recommended approaches to prevent, ameliorate and manage these toxicities.
  • Review the logistical and practical requirements associated with CAR T-cell therapy for MM in order to appropriately educate eligible patients.

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

CREDIT DESIGNATION STATEMENT
Video Interview: 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.

Video Lecture: Research To Practice designates this enduring material for a maximum of 0.75 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 short post-tests, enables the participant to earn up to 1 (video) and 0.75 (lecture) 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 specialties: 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
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, review the downloadable slide set, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Interview: ResearchToPractice.com/OncologyTodayCARTMM24/Video and evaluation ResearchToPractice.com/OncologyTodayCARTMM24/Video/CME.

Video Lecture: ResearchToPractice.com/OncologyTodayCARTMM24/Presentation and evaluation ResearchToPractice.com/OncologyTodayCARTMM24/Presentation/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 conflicts of interest 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:

Surbhi Sidana, MD
Associate Professor of Medicine
Director, Myeloma Disease Focused Group
Associate Director of Clinical Research
Division of Blood and Marrow Transplantation and Cellular Therapy
Stanford University
Stanford, California

Advisory Committees and Consulting Agreements: AbbVie Inc, Arcellx, BioLineRx, Bristol Myers Squibb, Genentech, a member of the Roche Group, Janssen Biotech Inc, Kite, A Gilead Company, Legend Biotech, Oncopeptides, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi, Takeda Pharmaceuticals USA Inc; Contracted Research: AbbVie Inc, Allogene Therapeutics, Bristol Myers Squibb, Janssen Biotech Inc,Magenta Therapeutics, Novartis.

EDITOR — 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: AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, 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, Hologic Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, 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, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, 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 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 Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, and Legend Biotech.

Release date: February 2025
Expiration date: February 2026

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

Anderson LD et al. Idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T cell therapy, in relapsed and refractory multiple myeloma: Updated KarMMa results. ASCO 2021;Abstract 8016.

Bal S et al. Efficacy and safety with extended follow-up in a phase 1 study of BMS-986393, a G protein-coupled receptor class C group 5 member D (GPRC5D)-targeted CAR T cell therapy, in patients (pts) with heavily pretreated relapsed/refractory (RR) multiple myeloma (MM). ASH 2024;Abstract 922.

Berdeja JG et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): A phase 1b/2 open-label study. Lancet 2021;398(10297):314-24. Abstract

Cohen AD et al. Incidence and management of CAR-T neurotoxicity in patients with multiple myeloma treated with ciltacabtagene autoleucel in CARTITUDE studies. Blood Cancer J 2022;12(2):32. Abstract

Dhakal B et al. First phase 3 results from CARTITUDE-4: Cilta-cel versus standard of care (PVd or DPd) in lenalidomide-refractory multiple myeloma. ASCO 2023;Abstract LBA106.

Ferreri CJ et al. Real-world experience of patients with multiple myeloma receiving ide-cel after a prior BCMA-targeted therapy. Blood Cancer J 2023;13(1):117. Abstract

Freeman CL et al. Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: Preliminary results from the IMMagine-1 trial. ASH 2024;Abstract 1031.

Graham CE et al. Chemotherapy-induced reversal of ciltacabtagene autoleucel-associated movement and neurocognitive toxicity. Blood 2023;142(14):1248-52. Abstract

Hansen DK et al. Comparative safety and efficacy of ciltacabtagene autoleucel and idecabtagene vicleucel CAR T-cell therapies in relapsed or refractory multiple myeloma. ASH 2024;Abstract 936.

Hansen DK et al. Idecabtagene vicleucel for relapsed/refractory multiple myeloma: Real-world experience from the myeloma CAR T consortium. J Clin Oncol 2023;41(11):2087-97. Abstract

Harrison SJ et al. CAR+ T-cell lymphoma post ciltacabtagene autoleucel therapy for relapsed refractory multiple myeloma. ASH 2023;Abstract 6939.

Lin Y et al. CARTITUDE-1 final results: Phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma. ASCO 2023;Abstract 8009.

Martin T et al. Ciltacabtagene autoleucel, an anti-B-cell maturation antigen chimeric antigen receptor T-cell therapy, for relapsed/refractory multiple myeloma: CARTITUDE-1 2-year follow-up. J Clin Oncol 2023;41(6):1265-74. Abstract

Martin T et al. Updated results from CARTITUDE-1: Phase 1b/2 study of ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T cell therapy, in patients with relapsed/refractory multiple myeloma. ASH 2021;Abstract 549.

Mateos M-V et al. Overall survival (OS) with ciltacabtagene autoleucel (cilta-cel) versus standard of care (SoC) in lenalidomide (Len)-refractory multiple myeloma (MM): Phase 3 CARTITUDE-4 study update. IMS 2024;Abstract OA-65.

Munshi NC et al. Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N Engl J Med 2021;384(8):705-16. Abstract

Rodríguez-Otero P et al. Idecabtagene vicleucel (ide-cel) versus standard (std) regimens in patients (pts) with triple-class-exposed (TCE) relapsed and refractory multiple myeloma (RRMM): Updated analysis from KarMMa-3. ASH 2023;Abstract 1028.

Rodríguez-Otero P et al. Ide-cel or standard regimens in relapsed and refractory multiple myeloma. N Engl J Med 2023;388(11):1002-14. Abstract

San-Miguel J et al. Cilta-cel or standard care in lenalidomide-refractory multiple myeloma. N Engl J Med 2023;389(4):335-47. Abstract

Sidana S et al. Safety and efficacy of standard-of-care ciltacabtagene autoleucel for relapsed/refractory multiple myeloma. Blood 2025;145(1):85-97. Abstract

Sidana S et al Ciltacabtagene autoleucel vs standard of care in patients with functionally high-risk multiple myeloma: CARTITUDE-4 subgroup analysis. IMS 2023;Abstract P-082.

Sidana S et al. Real world outcomes with idecabtagene vicleucel (ide-cel) CAR-T cell therapy for relapsed/refractory multiple myeloma. ASH 2023;Abstract 1027.

Usmani SZ et al. Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed/refractory multiple myeloma (R/R MM): Updated results from CARTITUDE-1. ASCO 2021;Abstract 8005.

Van De Donk NWCJ et al. Clinical experience with cranial nerve impairment in the CARTITUDE-1, CARTITUDE-2 cohorts A, B, and C, and CARTITUDE-4 studies of ciltacabtagene autoleucel (cilta-cel). ASH 2023;Abstract 3501.

Van Oekelen O et al. Neurocognitive and hypokinetic movement disorder with features of parkinsonism after BCMA-targeting CAR-T cell therapy. Nat Med 2021;27(12):2099-103. Abstract