Faculty

TARGET AUDIENCE
This program is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of prostate cancer.

LEARNING OBJECTIVES

• Infer how various clinical and biological factors affect the risk of prostate cancer recurrence after local therapy, and design appropriate treatment plans for individual patients with consideration of the potential benefits and risks of new and established forms of hormonal therapy.
• Appraise published research findings on optimal management approaches for patients with biochemical recurrence after local treatment for prostate cancer, and counsel appropriate individuals regarding the potential benefits of FDA-approved systemic treatment options.
• Evaluate the published research database supporting the FDA approvals of secondary hormonal agents for the management of nonmetastatic prostate cancer, and apply this information in the discussion of nonresearch treatment options.
• Explore available data with the use of treatment intensification with cytotoxic therapy, secondary hormonal therapy or combinations of these approaches for metastatic hormone-sensitive prostate cancer (mHSPC), and effectively integrate these strategies into current clinical management algorithms.
• Establish an evidence-based approach to the selection and sequencing of available therapeutic options for patients with metastatic castration-resistant prostate cancer, considering age, comorbidities, prior therapeutic exposure and other relevant clinical and biological factors.
• Assess the available research database supporting the use of PARP inhibitors in combination with androgen receptor pathway inhibitors for patients with metastatic prostate cancer harboring a homologous recombination repair gene alteration, and discern how to optimally incorporate these agents into current clinical management algorithms.
• Appreciate the biological rationale for targeting the PI3K/AKT/mTOR pathway for prostate cancer, and evaluate available and emerging data with novel AKT inhibitors in combination with hormonal therapy for patients with mHSPC and PTEN deficiency.
• Review available and emerging Phase III data documenting the efficacy of various forms of radioligand therapy for patients with metastatic prostate cancer, and consider the current and potential future clinical role of these strategies.
• Recall the design of ongoing clinical trials evaluating other novel agents and strategies for prostate cancer, and counsel appropriate patients about availability and 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, this program hasbeen 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/Prostate/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:

Andrew J Armstrong, MD, ScM
Professor of Medicine, Surgery, Pharmacology and Cancer Biology
Director of Research
Duke Cancer Institute Center for Prostate and Urologic Cancers
Division of Medical Oncology
Departments of Medicine and Urology
Duke University
Durham, North Carolina

Advisory Committees: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Merck, Pfizer Inc, Precede Biosciences, Sumitomo Pharma America, Telix Pharmaceuticals Limited; Consulting Agreements: Amgen Inc, Astellas, Bayer HealthCare Pharmaceuticals, Janssen Biotech Inc, Novartis, Pfizer Inc; Contracted Research: Amgen Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, FibroGen Inc, Janssen Biotech Inc, Merck, Novartis, Pathos, Pfizer Inc.

Scott T Tagawa, MD, MS
Professor of Medicine and Urology
Weill Cornell Medicine
Leader, GU Disease Management Team
Meyer Cancer Center
New York, New York

Consulting Agreements: AbbVie Inc, Abdera Therapeutics, Bayer HealthCare Pharmaceuticals, Biohaven, Blue Earth Diagnostics, Boston Scientific Corporation, Clarity Pharmaceuticals, Convergent Therapeutics Inc, Daiichi Sankyo Inc, EMD Serono Inc, GE Healthcare, Gilead Sciences Inc, Johnson & Johnson, Lantheus, Lilly, Merck, Myovant Sciences, Novartis, Pfizer Inc, Regeneron Pharmaceuticals Inc, Telix Pharmaceuticals Limited; Contracted Research: AIQ Solutions, Bayer HealthCare Pharmaceuticals, Clarity Pharmaceuticals, Gilead Sciences Inc, Janux Therapeutics, Johnson & Johnson, Lilly, Merck, Novartis, Pfizer Inc, Telix Pharmaceuticals Limited; Data and Safety Monitoring Boards/Committees: Boston Scientific Corporation; Stock OPTIONS — Private Companies: Convergent Therapeutics.

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 AstraZeneca Pharmaceuticals LP, Merck, Novartis, and Sumitomo Pharma America and Pfizer 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.

Aggarwal R et al. Final results from PRESTO: A phase III open-label study of combined androgen blockade in patients (pts) with high-risk biochemically relapsed prostate cancer (BRPC) (AFT-19). ESMO 2025;Abstract LBA88.

Armstrong AJ et al. Trial design and objectives for patients with prostate cancer: Recommendations from the prostate cancer working group 4. J Clin Oncol 2026;[Online ahead of print]. Abstract

De Bono JS et al. IDeate-Prostate02: A phase 1/2, open-label umbrella substudy of ifinatamab deruxtecan-based treatment combinations or as monotherapy in participants with previously treated metastatic castration-resistant prostate cancer. Genitourinary Cancers Symposium 2026;Abstract TPS297.

De La Cerda J et al. Safety and tolerability of relugolix in combination with abiraterone or apalutamide for treatment of patients with advanced prostate cancer: Data from a 52-week clinical trial. Target Oncol 2025;20(3):503-17. Abstract

Emmett L et al. PSMAcTION trial-in-progress: A phase II/III randomized trial of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) versus standard of care in patients with PSMA-positive metastatic castration-resistant prostate cancer who progressed on or after [177Lu]Lu-PSMA therapy. ESMO 2025;Abstract 2516TiP.

Fizazi K et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol 2026;37(1):53-68. Abstract

Fizazi K et al. OMAHA-004: Phase 3 trial of CYP11A1 inhibitor opevesostat versus androgen receptor pathway inhibitor (ARPI) switch in participants with metastatic castration-resistant prostate cancer (mCRPC) after a prior ARPI. Genitourinary Cancers Symposium 2026;Abstract TPS299.

Fizazi K et al. Final overall survival and safety analyses of the phase III PSMAfore trial of [(177)Lu]Lu-PSMA-617 versus change of androgen receptor pathway inhibitor in taxane-naive patients with metastatic castration-resistant prostate cancer. Ann Oncol 2025;36(11):1319-30. Abstract

Francolini G et al. Ultra-hypofractionated radiotherapy and concomitant oral relugolix for treatment of intermediate risk prostate cancer (ULTRA-HERO). Genitourinary Cancers Symposium 2026;Abstract TPS411.

Freedland SJ et al. Effects of enzalutamide on the sexual activity of patients with biochemically recurrent prostate cancer: A post hoc analysis of patient-reported outcomes in the EMBARK study. Eur Urol 2025;87(5):507-11. Abstract

Gallardo E et al. Final overall survival results from the EORTC 1333/PEACE-3 trial: Enzalutamide with or without radium-223 in metastatic castration-resistant prostate cancer. Genitourinary Cancers Symposium 2026;Abstract 15.

George DJ et al. Patient reported outcomes (PRO) and tolerability of capivasertib (capi) plus abiraterone (abi) versus placebo (pbo) plus abi in patients (pts) with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. Genitourinary Cancers Symposium 2026;Abstract 14.

Grimm M-O et al. 3-weekly docetaxel 75 mg/m² vs 2-weekly docetaxel 50 mg/m² in combination with darolutamide + ADT in patients with mHSPC: Results from the randomised phase III ARASAFE trial. ESMO 2025;Abstract LBA92.

McKay RR et al. IDeate-Prostate01: A phase 3, randomized, open-label study of ifinatamab deruxtecan versus docetaxel in participants with previously treated metastatic castration-resistant prostate cancer. Genitourinary Cancers Symposium 2026;Abstract TPS294.

McKay RR et al. Phase III, randomized, double-blind, placebo-controlled study of adjuvant saruparib (AZD5305) in patients with BRCAm localized high-risk prostate cancer who are receiving radiotherapy and androgen deprivation therapy (EvoPAR-Prostate02). Genitourinary Cancers Symposium 2026;Abstract TPS412.

McKay RR et al. Quality of life, adherence, and adverse events among patients with advanced prostate cancer treated with relugolix: 6-month results of the OPTYX multicenter registry. Genitourinary Cancers Symposium 2026;Abstract 122.

Morgans AK et al. Health-related quality of life (HRQoL) outcomes with darolutamide in the phase 3 ARANOTE trial. ASCO 2025;Abstract 5004.

Sathekge MM et al. Actinium-225-PSMA radioligand therapy of metastatic castration-resistant prostate cancer (WARMTH Act): A multicentre, retrospective study. Lancet Oncol 2024;25(2):175-83. Abstract

Shore ND et al. Improved survival with enzalutamide in biochemically recurrent prostate cancer. N Engl J Med 2026;394(6):563-75. Abstract

Stein MN et al. Pasritamig, a first-in-class, bispecific T-cell engager targeting human kallikrein 2, in metastatic castration-resistant prostate cancer: A phase I study. J Clin Oncol 2025;43(22):2515-26. Abstract

Tagawa ST et al. Phase III trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition). ESMO 2025;Abstract LBA6.

Yu EY et al. OMAHA-003: Phase 3 trial of CYP11A1 inhibitor opevesostat versus androgen receptor pathway inhibitor (ARPI) switch in participants (pts) with metastatic castration-resistant prostate cancer (mCRPC) after ARPI and taxane-based chemotherapy. Genitourinary Cancers Symposium 2026;Abstract TPS298.

Faculty

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

LEARNING OBJECTIVES

• Appreciate the incidence of KMT2A translocations or NPM1 mutations in patients with acute leukemias, and understand the significance of these abnormalities for prognosis, biomarker assessment and current disease management.
• Describe the mechanism of action of menin inhibitors, and review the rationale for their activity in patients with KMT2A-rearranged and NPM1-mutant acute leukemias.
• Evaluate available efficacy and safety data with menin inhibitors for patients with previously treated KMT2A-rearranged acute leukemias, and optimally integrate FDA-approved agents into management algorithms.
• Assess published clinical trial findings with menin inhibitors for the treatment of NPM1-mutant acute myeloid leukemia (AML), and consider the implications for current and future management.
• Understand the spectrum, incidence and severity of side effects, including differentiation syndrome and cardiac toxicity, associated with menin inhibitors, and develop appropriate monitoring and management protocols.
• Appreciate ongoing research efforts attempting to further define the role of menin inhibitors alone and in combination with other therapies in treatment for AML, and counsel patients regarding the benefits of 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
Video Proceedings: 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 1.25 (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 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
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/YIR2025/MeninAML/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:

Amir Fathi, MD
Director, Leukemia Program
Massachusetts General Hospital
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: AbbVie Inc, Astellas, AstraZeneca Pharmaceuticals LP, Autolus, Bristol Myers Squibb, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Genmab US Inc, Gilead Sciences Inc, Kura Oncology, Pfizer Inc, Prelude Therapeutics, Remix Therapeutics, Rigel Pharmaceuticals Inc, Schrödinger, Servier Pharmaceuticals LLC, Syndax Pharmaceuticals, Takeda Pharmaceuticals USA Inc, Thermo Fisher Scientific; Contracted Research: AbbVie Inc, Bristol Myers Squibb, Kura Oncology, Servier Pharmaceuticals LLC.

Eunice S Wang, MD
Chief, Leukemia/Benign Hematology Service
Professor of Oncology, Department of Medicine
Roswell Park Comprehensive Cancer Center
Buffalo, New York

Advisory Boards: AbbVie Inc, Blueprint Medicines, Cullinan Therapeutics, Daiichi Sankyo Inc, Dark Blue Therapeutics, Johnson & Johnson, Kite, A Gilead Company, Kura Oncology, Novartis, QIAGEN, Rigel Pharmaceuticals Inc, Ryvu Therapeutics, Schrödinger, Servier Pharmaceuticals LLC, Syndax Pharmaceuticals, Takeda Pharmaceuticals USA Inc; Consulting Agreements: Kura Oncology, Menarini Group; Data and Safety Monitoring Boards/Committees: AbbVie Inc, Gilead Sciences Inc; Speakers Bureaus: Astellas, Pfizer Inc; Nonrelevant Financial Relationships: UpToDate.

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.

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 Johnson & Johnson, Kura Oncology, and Syndax Pharmaceuticals.

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.

Aldoss I et al. Updated results and longer follow-up from the AUGMENT-101 phase 2 study of revumenib in patients with relapsed or refractory (R/R) KMT2Ar acute leukemia. EHA 2025;Abstract PS1473.

Arellano ML et al. Patients with relapsed or refractory R/R) nucleophosmin 1-mutated (NPM1m) acute myeloid leukemia (AML): Updated results from the phase 2 AUGMENT-101 study. EHA 2025;Abstract PS1467.

Daver N et al. Monotherapy update from phase 1 portion in phase1/2 trial of the menin-MLL inhibitor enzomenib (DSP-5336) in patients with relapsed or refractory acute leukemia. ASH 2025;Abstract 763.

Döhner H et al. Bleximenib in combination with intensive chemotherapy: A phase 1b study in newly diagnosed acute myeloid leukemia with KMT2A or NPM1 alterations. ASH 2025;Abstract 5199.

Erba H et al. Ziftomenib combined with intensive induction chemotherapy (7+3) in newly diagnosed NPM1-M or KMT2A-R acute myeloid leukemia (AML): Updated phase 1a/b results from KOMET-007. EHA 2025;Abstract S136.

Fathi A et al. Results from paradigm — A phase 2 randomized multi-center study comparing azacitidine and venetoclax to conventional induction chemotherapy for newly diagnosed fit adults with acute myeloid leukemia. ASH 2025;Abstract 6.

Huether R et al. Detection of KMT2A partial tandem duplication (PTD) in AML by whole genome sequencing (WGS): Addressing limitations of traditional techniques in the era of revumenib approval. ASCO 2025;Abstract 6532.

Issa G et al. Revumenib activity in patients with acute leukemia with NUP98r: Results from the AUGMENT-101 phase 1 study. EHA 2025;Abstract PS1501.

Issa G et al. Ziftomenib in combination with venetoclax and azacitidine in relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia: Updated phase 1a/b safety and clinical activity results from KOMET-007. ASH 2025;Abstract 764.

Issa GC et al. Combination strategies with menin inhibitors for acute leukemia. Blood Cancer Discov 2025;6(6):547-560. Abstract

Jen W-Y et al. Phase II study of the all-oral combination of revumenib (SNDX-5613) with decitabine/cedazuridine (ASTX727) and venetoclax (SAVE) in newly diagnosed AML. ASH 2025;Abstract 47.

Roboz G et al. Ziftomenib in combination with venetoclax and azacitidine in newly diagnosed NPM1-m acute myeloid leukemia: Phase 1b results from KOMET-007. ASH 2025;Abstract 766.

Shukla N et al. Detection of MEN1 resistance mutations in cell-free DNA from acute leukemia patients treated with menin inhibitors. ASH 2025;Abstract 938.

Veiga RR et al. Real world outcomes in a series of 417 adult patients with KMT2A (MLL) gene rearranged acute myeloid leukemia. EHA 2025;Abstract S147.

Wang ES at al. Ziftomenib in relapsed or refractory NPM1-mutated AML. J Clin Oncol 2025;43(31):3381-90. Abstract

Watts J et al. Preliminary data from the ongoing phase 1 study of the menin-MLL inhibitor enzomenib (DSP-5336) in combination with venetoclax and azacitidine in patients with relapsed or refractory acute myeloid leukemia. ASH 2025;Abstract 765.

Wei AH et al. RP2D determination of bleximenib in combination with VEN + AZA: Phase 1b study in ND & R/R AML with KMT2A/NPM1 alterations. EHA 2025;Abstract S137.

Zeidner JF et al. Azacitidine, venetoclax, and revumenib for newly diagnosed NPM1-mutated or KMT2A-rearranged AML. J Clin Oncol 2025;43(23):2606-15. 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 acute myeloid leukemia.

LEARNING OBJECTIVES

• Appreciate the incidence of KMT2A translocations or NPM1 mutations in patients with acute leukemias, and understand the significance of these abnormalities for prognosis, biomarker assessment and current disease management.
• Describe the mechanism of action of menin inhibitors, and review the rationale for their activity in patients with KMT2A-rearranged and NPM1-mutant acute leukemias.
• Evaluate available efficacy and safety data with menin inhibitors for patients with previously treated KMT2A-rearranged acute leukemias, and optimally integrate FDA-approved agents into management algorithms.
• Assess published clinical trial findings with menin inhibitors for the treatment of NPM1-mutant acute myeloid leukemia (AML), and consider the implications for current and future management.
• Understand the spectrum, incidence and severity of side effects, including differentiation syndrome and cardiac toxicity, associated with menin inhibitors, and develop appropriate monitoring and management protocols.
• Appreciate ongoing research efforts attempting to further define the role of menin inhibitors alone and in combination with other therapies in treatment for AML, and counsel patients regarding the benefits of 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.comYIR2025/MeninAML/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:

Amir Fathi, MD
Director, Leukemia Program
Massachusetts General Hospital
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: AbbVie Inc, Astellas, AstraZeneca Pharmaceuticals LP, Autolus, Bristol Myers Squibb, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Genmab US Inc, Gilead Sciences Inc, Kura Oncology, Pfizer Inc, Prelude Therapeutics, Remix Therapeutics, Rigel Pharmaceuticals Inc, Schrödinger, Servier Pharmaceuticals LLC, Syndax Pharmaceuticals, Takeda Pharmaceuticals USA Inc, Thermo Fisher Scientific; Contracted Research: AbbVie Inc, Bristol Myers Squibb, Kura Oncology, Servier Pharmaceuticals LLC.

Eunice S Wang, MD
Chief, Leukemia/Benign Hematology Service
Professor of Oncology, Department of Medicine
Roswell Park Comprehensive Cancer Center
Buffalo, New York

Advisory Boards: AbbVie Inc, Blueprint Medicines, Cullinan Therapeutics, Daiichi Sankyo Inc, Dark Blue Therapeutics, Johnson & Johnson, Kite, A Gilead Company, Kura Oncology, Novartis, QIAGEN, Rigel Pharmaceuticals Inc, Ryvu Therapeutics, Schrödinger, Servier Pharmaceuticals LLC, Syndax Pharmaceuticals, Takeda Pharmaceuticals USA Inc; Consulting Agreements: Kura Oncology, Menarini Group; Data and Safety Monitoring Boards/Committees: AbbVie Inc, Gilead Sciences Inc; Speakers Bureaus: Astellas, Pfizer Inc; Nonrelevant Financial Relationships: UpToDate.

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.

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 Johnson & Johnson, Kura Oncology, and Syndax Pharmaceuticals.

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.

Aldoss I et al. Updated results and longer follow-up from the AUGMENT-101 phase 2 study of revumenib in patients with relapsed or refractory (R/R) KMT2Ar acute leukemia. EHA 2025;Abstract PS1473.

Arellano ML et al. Patients with relapsed or refractory R/R) nucleophosmin 1-mutated (NPM1m) acute myeloid leukemia (AML): Updated results from the phase 2 AUGMENT-101 study. EHA 2025;Abstract PS1467.

Daver N et al. Monotherapy update from phase 1 portion in phase1/2 trial of the menin-MLL inhibitor enzomenib (DSP-5336) in patients with relapsed or refractory acute leukemia. ASH 2025;Abstract 763.

Döhner H et al. Bleximenib in combination with intensive chemotherapy: A phase 1b study in newly diagnosed acute myeloid leukemia with KMT2A or NPM1 alterations. ASH 2025;Abstract 5199.

Erba H et al. Ziftomenib combined with intensive induction chemotherapy (7+3) in newly diagnosed NPM1-M or KMT2A-R acute myeloid leukemia (AML): Updated phase 1a/b results from KOMET-007. EHA 2025;Abstract S136.

Fathi A et al. Results from paradigm — A phase 2 randomized multi-center study comparing azacitidine and venetoclax to conventional induction chemotherapy for newly diagnosed fit adults with acute myeloid leukemia. ASH 2025;Abstract 6.

Huether R et al. Detection of KMT2A partial tandem duplication (PTD) in AML by whole genome sequencing (WGS): Addressing limitations of traditional techniques in the era of revumenib approval. ASCO 2025;Abstract 6532.

Issa G et al. Revumenib activity in patients with acute leukemia with NUP98r: Results from the AUGMENT-101 phase 1 study. EHA 2025;Abstract PS1501.

Issa G et al. Ziftomenib in combination with venetoclax and azacitidine in relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia: Updated phase 1a/b safety and clinical activity results from KOMET-007. ASH 2025;Abstract 764.

Issa GC et al. Combination strategies with menin inhibitors for acute leukemia. Blood Cancer Discov 2025;6(6):547-560. Abstract

Jen W-Y et al. Phase II study of the all-oral combination of revumenib (SNDX-5613) with decitabine/cedazuridine (ASTX727) and venetoclax (SAVE) in newly diagnosed AML. ASH 2025;Abstract 47.

Roboz G et al. Ziftomenib in combination with venetoclax and azacitidine in newly diagnosed NPM1-m acute myeloid leukemia: Phase 1b results from KOMET-007. ASH 2025;Abstract 766.

Shukla N et al. Detection of MEN1 resistance mutations in cell-free DNA from acute leukemia patients treated with menin inhibitors. ASH 2025;Abstract 938.

Veiga RR et al. Real world outcomes in a series of 417 adult patients with KMT2A (MLL) gene rearranged acute myeloid leukemia. EHA 2025;Abstract S147.

Wang ES at al. Ziftomenib in relapsed or refractory NPM1-mutated AML. J Clin Oncol 2025;43(31):3381-90. Abstract

Watts J et al. Preliminary data from the ongoing phase 1 study of the menin-MLL inhibitor enzomenib (DSP-5336) in combination with venetoclax and azacitidine in patients with relapsed or refractory acute myeloid leukemia. ASH 2025;Abstract 765.

Wei AH et al. RP2D determination of bleximenib in combination with VEN + AZA: Phase 1b study in ND & R/R AML with KMT2A/NPM1 alterations. EHA 2025;Abstract S137.

Zeidner JF et al. Azacitidine, venetoclax, and revumenib for newly diagnosed NPM1-mutated or KMT2A-rearranged AML. J Clin Oncol 2025;43(23):2606-15. 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 acute myeloid leukemia.

LEARNING OBJECTIVES

• Appreciate the incidence of KMT2A translocations or NPM1 mutations in patients with acute leukemias, and understand the significance of these abnormalities for prognosis, biomarker assessment and current disease management.
• Describe the mechanism of action of menin inhibitors, and review the rationale for their activity in patients with KMT2A-rearranged and NPM1-mutant acute leukemias.
• Evaluate available efficacy and safety data with menin inhibitors for patients with previously treated KMT2A-rearranged acute leukemias, and optimally integrate FDA-approved agents into management algorithms.
• Assess published clinical trial findings with menin inhibitors for the treatment of NPM1-mutant acute myeloid leukemia (AML), and consider the implications for current and future management.
• Understand the spectrum, incidence and severity of side effects, including differentiation syndrome and cardiac toxicity, associated with menin inhibitors, and develop appropriate monitoring and management protocols.
• Appreciate ongoing research efforts attempting to further define the role of menin inhibitors alone and in combination with other therapies in treatment for AML, and counsel patients regarding the benefits of 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.comYIR2025/MeninAML/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:

Amir Fathi, MD
Director, Leukemia Program
Massachusetts General Hospital
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Consulting Agreements: AbbVie Inc, Astellas, AstraZeneca Pharmaceuticals LP, Autolus, Bristol Myers Squibb, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Genmab US Inc, Gilead Sciences Inc, Kura Oncology, Pfizer Inc, Prelude Therapeutics, Remix Therapeutics, Rigel Pharmaceuticals Inc, Schrödinger, Servier Pharmaceuticals LLC, Syndax Pharmaceuticals, Takeda Pharmaceuticals USA Inc, Thermo Fisher Scientific; Contracted Research: AbbVie Inc, Bristol Myers Squibb, Kura Oncology, Servier Pharmaceuticals LLC.

Eunice S Wang, MD
Chief, Leukemia/Benign Hematology Service
Professor of Oncology, Department of Medicine
Roswell Park Comprehensive Cancer Center
Buffalo, New York

Advisory Boards: AbbVie Inc, Blueprint Medicines, Cullinan Therapeutics, Daiichi Sankyo Inc, Dark Blue Therapeutics, Johnson & Johnson, Kite, A Gilead Company, Kura Oncology, Novartis, QIAGEN, Rigel Pharmaceuticals Inc, Ryvu Therapeutics, Schrödinger, Servier Pharmaceuticals LLC, Syndax Pharmaceuticals, Takeda Pharmaceuticals USA Inc; Consulting Agreements: Kura Oncology, Menarini Group; Data and Safety Monitoring Boards/Committees: AbbVie Inc, Gilead Sciences Inc; Speakers Bureaus: Astellas, Pfizer Inc; Nonrelevant Financial Relationships: UpToDate.

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.

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 Johnson & Johnson, Kura Oncology, and Syndax Pharmaceuticals.

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.

Aldoss I et al. Updated results and longer follow-up from the AUGMENT-101 phase 2 study of revumenib in patients with relapsed or refractory (R/R) KMT2Ar acute leukemia. EHA 2025;Abstract PS1473.

Arellano ML et al. Patients with relapsed or refractory R/R) nucleophosmin 1-mutated (NPM1m) acute myeloid leukemia (AML): Updated results from the phase 2 AUGMENT-101 study. EHA 2025;Abstract PS1467.

Daver N et al. Monotherapy update from phase 1 portion in phase1/2 trial of the menin-MLL inhibitor enzomenib (DSP-5336) in patients with relapsed or refractory acute leukemia. ASH 2025;Abstract 763.

Döhner H et al. Bleximenib in combination with intensive chemotherapy: A phase 1b study in newly diagnosed acute myeloid leukemia with KMT2A or NPM1 alterations. ASH 2025;Abstract 5199.

Erba H et al. Ziftomenib combined with intensive induction chemotherapy (7+3) in newly diagnosed NPM1-M or KMT2A-R acute myeloid leukemia (AML): Updated phase 1a/b results from KOMET-007. EHA 2025;Abstract S136.

Fathi A et al. Results from paradigm — A phase 2 randomized multi-center study comparing azacitidine and venetoclax to conventional induction chemotherapy for newly diagnosed fit adults with acute myeloid leukemia. ASH 2025;Abstract 6.

Huether R et al. Detection of KMT2A partial tandem duplication (PTD) in AML by whole genome sequencing (WGS): Addressing limitations of traditional techniques in the era of revumenib approval. ASCO 2025;Abstract 6532.

Issa G et al. Revumenib activity in patients with acute leukemia with NUP98r: Results from the AUGMENT-101 phase 1 study. EHA 2025;Abstract PS1501.

Issa G et al. Ziftomenib in combination with venetoclax and azacitidine in relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia: Updated phase 1a/b safety and clinical activity results from KOMET-007. ASH 2025;Abstract 764.

Issa GC et al. Combination strategies with menin inhibitors for acute leukemia. Blood Cancer Discov 2025;6(6):547-560. Abstract

Jen W-Y et al. Phase II study of the all-oral combination of revumenib (SNDX-5613) with decitabine/cedazuridine (ASTX727) and venetoclax (SAVE) in newly diagnosed AML. ASH 2025;Abstract 47.

Roboz G et al. Ziftomenib in combination with venetoclax and azacitidine in newly diagnosed NPM1-m acute myeloid leukemia: Phase 1b results from KOMET-007. ASH 2025;Abstract 766.

Shukla N et al. Detection of MEN1 resistance mutations in cell-free DNA from acute leukemia patients treated with menin inhibitors. ASH 2025;Abstract 938.

Veiga RR et al. Real world outcomes in a series of 417 adult patients with KMT2A (MLL) gene rearranged acute myeloid leukemia. EHA 2025;Abstract S147.

Wang ES at al. Ziftomenib in relapsed or refractory NPM1-mutated AML. J Clin Oncol 2025;43(31):3381-90. Abstract

Watts J et al. Preliminary data from the ongoing phase 1 study of the menin-MLL inhibitor enzomenib (DSP-5336) in combination with venetoclax and azacitidine in patients with relapsed or refractory acute myeloid leukemia. ASH 2025;Abstract 765.

Wei AH et al. RP2D determination of bleximenib in combination with VEN + AZA: Phase 1b study in ND & R/R AML with KMT2A/NPM1 alterations. EHA 2025;Abstract S137.

Zeidner JF et al. Azacitidine, venetoclax, and revumenib for newly diagnosed NPM1-mutated or KMT2A-rearranged AML. J Clin Oncol 2025;43(23):2606-15. Abstract

Faculty

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

LEARNING OBJECTIVES

• Understand the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker in lung cancer, and recognize the rationale for its use in detecting molecular residual disease (MRD) in patients.
• Outline optimal approaches for ctDNA-based assessment of MRD, and determine the appropriate timing and platform for testing ctDNA status in patients with lung cancer.
• Appreciate published datasets documenting the clinical utility of ctDNA testing in risk stratification, surveillance and therapeutic decision-making for patients with lung cancer, and consider the current and potential role of this strategy in personalizing treatment recommendations.
• Recall ongoing efforts evaluating ctDNA-based assays to assist with clinical decision-making in lung cancer, and appropriately refer patients 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 Program: 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 and 0.75 (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) — 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/5MJC2025/ctDNAAssays/Lung/Video and evaluation ResearchToPractice.com/5MJC2025/ctDNAAssays/Lung/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:

Natalie Vokes, MD
Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, Texas

Advisory Committees: Amgen Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Catalyst Pharmaceuticals Inc, Delcath Systems Inc, ImmunityBio, Lilly, Oncocyte, OncoHost, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi, Summit Therapeutics, Tango Therapeutics, Tempus, Xencor; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, EMD Serono Inc, IDEAYA Biosciences, Mirati Therapeutics Inc, OncoHost, Regeneron Pharmaceuticals Inc, Sanofi; Speakers Bureaus: Guardant Health.

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: 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.

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 Natera 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.

Anagnostou V et al. A biomarker-directed, multi-center phase II/III study of ctDNA molecular response adaptive immuno-chemotherapy in patients with non-small cell lung cancer (BR.36). ASCO 2025;Abstract TPS8669.

Anagnostou V et al. ctDNA response after pembrolizumab in non-small cell lung cancer: Phase 2 adaptive trial results. Nat Med 2023;29(10):2559-69. Abstract

Becharano G et al. Clinical performance of a tumor informed whole genome based ctDNA assay for predicting recurrence in early-stage resectable NSCLC. World Conference on Lung Cancer 2025;Abstract MA03.02.

Black JRM et al. Ultrasensitive ctDNA detection for preoperative disease stratification in early-stage lung adenocarcinoma. Nat Med 2025;31(1):70-6. Abstract

Felip E et al. Five-year survival outcomes with atezolizumab after chemotherapy in resected stage IB-IIIA non-small cell lung cancer (IMpower010): An open-label, randomized, phase III trial. J Clin Oncol 2025;43(21):2343-9. Abstract

Forde PM et al. Overall survival with neoadjuvant nivolumab plus chemotherapy in lung cancer. N Engl J Med 2025;393(8):741-52. Abstract

George MA et al. Clinical performance of Signatera genome assay in a cohort of patients (pts) with solid tumors. ASCO 2025;Abstract 3142.

Herbst RS et al. Molecular residual disease analysis of adjuvant osimertinib in resected EGFR-mutated stage IB-IIIA non-small-cell lung cancer. Nat Med 2025;31(6):1958-68. Abstract

Kasi PM et al. BESPOKE IO protocol: A multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours. BMJ Open 2022;12(5):e060342. Abstract

Masuda K et al. MRDSEEKER (JCOG2111A): A prospective study to evaluate MRD and its association with prognosis in curative-intent NSCLC. World Conference on Lung Cancer 2025;Abstract P3.18.04.

Oh Y et al. Personalized, tumor-informed, ctDNA assay for detecting MRD in NSCLC patients receiving curative treatments. Thorac Cancer 2024;15(13):1095-102. Abstract

Ohara S et al. Clinical significance of perioperative MRD detected by ctDNA in patients with lung cancer with a long follow-up data: An exploratory study. JTO Clin Res Rep 2024;6(3):100762. Abstract

Reck M et al. Association of post-surgical MRD status with neoadjuvant ctDNA dynamics, genomic mutations, and clinical outcomes in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial. ASCO 2025;Abstract 8009.

Rosenlund L et al. ctDNA can detect MRD in curative treated non-small cell lung cancer (NSCLC) patients using a tumor agnostic approach. Lung Cancer 2025;203:108528. Abstract

Vokes NI et al. Circulating tumor DNA (ctDNA) dynamics and survival outcomes in patients (pts) with advanced non-small cell lung cancer (aNSCLC) and high (>50%) programmed cell death ligand 1 (PD-L1) expression, randomized to cemiplimab (cemi) vs chemotherapy (chemo). ASCO 2023;Abstract 9022.

Zhou C et al. IMpower010: Biomarkers of disease-free survival in a phase 3 study of atezolizumab vs best supportive care after adjuvant chemotherapy in stage IB-IIIA NSCLC. ESMO IO 2021;Abstract 2O.

Faculty

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

LEARNING OBJECTIVES

• Review how biological and patient-specific factors (eg, age, performance status, prior treatment, comorbidities and preexisting conditions) influence the selection and sequencing of treatment for metastatic urothelial bladder cancer (mUBC).
• Recognize the incidence of nectin-4 expression in patients with UBC, and appreciate the scientific justification for the development of antibody-drug conjugates (ADCs) targeting this novel biomarker.
• Interrogate published efficacy and safety findings with anti-PD-1/PD-L1 antibodies in combination with ADC therapy as first-line treatment for mUBC, and consider the current role of this strategy for patients with the disease.
• Recall pivotal clinical trial findings leading to the FDA approval of novel compounds (eg, ADCs, tyrosine kinase inhibitors) with unique mechanisms of action for previously treated locally advanced or mUBC, and identify patients for whom these approaches would be appropriate.
• Appreciate the frequency and severity of therapy-related adverse events commonly encountered by patients receiving guideline-endorsed agents and regimens for mUBC, and enact effective monitoring and management procedures for appropriate individuals.
• Describe the scientific justification for and published research data with novel strategies under investigation in UBC, and effectively prioritize clinical trial opportunities for eligible 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 Program: 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 0.75 (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) — 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, 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/RapidCaseReview2026/Bladder/1/Video and evaluation ResearchToPractice.com/RapidCaseReview2026/Bladder/1/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

Fern Anari, MD
Assistant Professor of Genitourinary Medical Oncology
Fox Chase Cancer Center
Philadelphia, Pennsylvania

Catherine Fahey, MD, PhD
Assistant Professor, Division of Oncology
Department of Medicine
Lineberger Comprehensive Cancer Center
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina

The following faculty reported relevant financial relationships with ineligible entities:

Matthew D Galsky, MD
Lillian and Howard Stratton Professor of Medicine
Icahn School of Medicine at Mount Sinai
Co-Leader, Bladder Cancer Center of Excellence
Associate Director, Translational Research
The Tisch Cancer Institute
New York, New York

Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, EMD Serono Inc, Gilead Sciences Inc, Janssen Biotech Inc, Merck, Pfizer Inc, Seagen Inc.

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: 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, 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 grantor.

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

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.

Aggarwal R et al. Final results from PRESTO: A phase III open-label study of combined androgen blockade in patients (pts) with high-risk biochemically relapsed prostate cancer (BRPC) (AFT-19). ESMO 2025;Abstract LBA88.

Azad AA et al. First interim efficacy analysis of the phase I/II PETRANHA trial of saruparib + androgen receptor pathway inhibitors (ARPI) in patients (pts) with metastatic prostate cancer (mPC). ESMO 2025;Abstract 2384MO.

Carles Galceran J et al. Time to response with talazoparib (TALA) + enzalutamide (ENZA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) in TALAPRO-2. ESMO 2025;Abstract 2428P.

Cho KS et al. Lymphovascular invasion of transurethral resection specimens as predictor as progression and metastasis in patients with newly diagnosed T1 bladder urothelial cancer. J Urol 2009;182(6):2625-30. Abstract

De Santis M et al. Durvalumab (D) in combination with bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial. ESMO 2025;Abstract LBA108.

Fizazi K et al. A phase III study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. ESMO 2025;Abstract 2383O.

Fizazi K et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol 2025;[Online ahead of print]. Abstract

Galsky MD et al. Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. ESMO 2025;Abstract 3068O.

Makker V et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) part 1 final analysis. ESMO 2025;Abstract 957P.

Necchi A et al. Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results. ESMO 2025;Abstract LBA112.

Nguyen PL et al. Randomised phase III trial of androgen deprivation therapy (ADT) with radiation therapy with or without enzalutamide for high risk, clinically localised prostate cancer: ENZARAD (ANZUP 1303). ESMO 2025;Abstract LBA86.

Powles TB et al. IMvigor011: A phase III trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer. ESMO 2025;Abstract LBA8.

Powles TB et al. A randomised phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). ESMO 2024;Abstract LBA5.

Powles T et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med 2024;391(19):1773-86. Abstract

Rha SY et al. Datopotamab deruxtecan (Dato-DXd) + rilvegostomig (rilve) in patients (pts) with locally advanced or metastatic urothelial cancer (a/mUC): Results from the phase II TROPION-PanTumor03 study. ESMO 2025;Abstract 3072MO.

Sheng X et al. Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression. ESMO 2025;Abstract LBA7.

Shore ND et al. EMBARK: Overall survival with enzalutamide in biochemically recurrent prostate cancer. ESMO 2025;Abstract LBA87.

Tagawa ST et al. Phase III trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition). ESMO 2025;Abstract LBA6.

van der Heijden MS et al. Health-related quality of life (HRQoL) outcomes from the NIAGARA trial of perioperative durvalumab (D) plus neoadjuvant chemotherapy (NAC) in muscle-invasive bladder cancer (MIBC). ESMO 2025;Abstract 3069MO.

Vulsteke C et al. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study. ESMO 2025;Abstract LBA2.

Faculty

TARGET AUDIENCE
This program is intended for medical oncologists, breast surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

LEARNING OBJECTIVES

• Review the pathophysiology and prognosis of hormone receptor (HR)-positive, HER2-positive breast cancer, and understand the implications for therapeutic decision-making.
• Appraise available clinical research data, current guideline recommendations and expert best practices to guide the selection of first-line and maintenance therapy for patients with newly diagnosed HR-positive, HER2-positive metastatic breast cancer (mBC).
• Assess recently published Phase III data with HER2-directed antibody-drug conjugate therapy as a component of first-line therapy, and consider the current role of this novel strategy in treatment for patients with HR-positive, HER2-positive mBC.
• Appreciate the biological rationale for and available research findings with CDK4/6 inhibition in combination with endocrine and anti-HER2 maintenance therapy for patients with HR-positive, HER2-positive mBC, and use this information to personalize treatment recommendations.

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 1.25 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 components and a post-test, enables the participant to earn up to 1.25 (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) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation component 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/FirstLineTherapyHER2mBC26/1/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:

Virginia F Borges, MD, MMSc
Professor of Medicine with Tenure
Robert F and Patricia Young Connor Endowed Chair in Young Women’s Breast Cancer Research
Deputy Division Head, Medical Oncology
Co-Director, Diane O’Connor Thompson Breast Center
Co-Director, Breast Cancer Research Program
Director, Young Women’s Breast Cancer Translational Program
University of Colorado Anschutz Medical Campus
Aurora, Colorado

Advisory Committees: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Pfizer Inc; Consulting Agreements: Gilead Sciences Inc, Olema Oncology, Pfizer Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Merck, Olema Oncology, Pfizer Inc.

Ian E Krop, MD, PhD
Associate Cancer Center Director for Clinical Research
Medical Director, Clinical Trials Office
Yale Cancer Center
Chief Scientific Officer
Translational Breast Cancer Research Consortium
New Haven, Connecticut

Advisory Committees: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Daiichi Sankyo Inc, EMD Serono Inc, Genentech, a member of the Roche Group, Lilly, Seagen Inc; Consulting Agreements: ALX Oncology, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Halda Therapeutics, Novartis; Contracted Research: Pfizer Inc; Data and Safety Monitoring Boards/Committees: Novartis, Seagen Inc.

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.

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 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.

Bischoff H, Petit T. CDK4/6 inhibitors in HER2-positive metastatic breast cancer. Clin Breast Cancer 2026;26(2):93-104. Abstract

Dieras V et al. HER2CLIMB-05: A phase III study of tucatinib versus placebo in combination with trastuzumab and pertuzumab as first-line maintenance therapy for HER2+ metastatic breast cancer. J Clin Oncol 2025;[Online ahead of print]. Abstract

Hamilton EP et al. HER2CLIMB-05: Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer. ASCO 2023;Abstract TPS1115.

Kuemmel S et al. heredERA Breast Cancer: A phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer. BMC Cancer 2024;24(1):641. Abstract

Loibl S et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for patients (pts) with HER2+ advanced/metastatic breast cancer (a/mBC): Additional analyses of DESTINY-Breast09 in key subgroups of interest. ESMO 2025;Abstract LBA18.

Metzger O et al. Palbociclib for hormone-receptor-positive, HER2-positive advanced breast cancer. N Engl J Med 2026;394(5):451-62. Abstract

Metzger O et al. Central nervous system outcomes from the phase III PATINA trial (AFT-38). San Antonio Breast Cancer Symposium 2025;Abstract RF4-01.

Swain SM et al. INAVO122: A phase III study of maintenance inavolisib or placebo + pertuzumab + trastuzumab following induction with pertuzumab + trastuzumab + a taxane in patients (pts) with PIK3CA-mutated, HER2-positive advanced breast cancer (HER2+ aBC). ASCO 2024;Abstract TPS1124.

Swain SM et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med 2015;372(8):724-34. Abstract

Tolaney SM et al. Trastuzumab deruxtecan plus pertuzumab for HER2-positive metastatic breast cancer. N Engl J Med 2025;[Online ahead of print]. Abstract

Tolaney SM et al. Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09. ASCO 2025;Abstract LBA1008.

Vaz-Luis IV et al. Health-related quality of life (HRQoL) from the PATINA trial (AFT-38): Impact of adding palbociclib to HER2 and endocrine therapy (ET) after induction in HR+/HER2+ metastatic breast cancer (MBC). ESMO 2025;Abstract 485MO.