Accreditation types: 1.25 ABIM MOC, ABS MOC, CME

Expires: August 2026

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Faculty

Haley Ellis

Haley Ellis

MD

Massachusetts General Hospital, Boston, Massachusetts

Medical Oncologist

Harvard Medical School, Boston, Massachusetts

Instructor of Medicine

James J Harding

James J Harding

MD

Memorial Sloan Kettering Cancer Center, New York, New York

Associate Attending

Weill Cornell Medical College, New York, New York

Assistant Professor of Medicine

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

LEARNING OBJECTIVES

  • Discuss the biological justification for the evaluation of immune checkpoint inhibitors for patients with advanced biliary tract cancers (BTCs), and develop strategies to optimally incorporate anti-PD-1/PD-L1 antibody-based approaches into the care of individuals with these diseases.
  • Recognize the molecular heterogeneity of cholangiocarcinomas and other BTCs, and appreciate the biological rationale for efforts to exploit documented abnormalities in patients with these diseases.
  • Assess key datasets supporting the recent FDA approvals of fibroblast growth factor receptor (FGFR) inhibitors for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement in order to optimally select and sequence these agents.
  • Evaluate available clinical trial findings with HER2-directed therapies for patients with HER2-positive BTCs, and contemplate the current utility of these agents for appropriately selected individuals.
  • Recall available and emerging data with investigational agents and strategies currently in clinical testing for BTCs, and appropriately refer patients for trial participation.

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

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

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation 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 each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

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

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation 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
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/PPGI2025/2/BTC/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:

Haley Ellis, MD
Medical Oncologist
Massachusetts General Hospital
Instructor of Medicine
Harvard Medical School
Boston, Massachusetts

Advisory Committees: AstraZeneca Pharmaceuticals LP, Cogent Biosciences, Jazz Pharmaceuticals Inc; Honoraria: Incyte Corporation, Jazz Pharmaceuticals Inc; Nonrelevant Financial Relationships: Medscape, OncLive, The Jackson Laboratory.

James J Harding, MD
Associate Attending
Memorial Sloan Kettering Cancer Center
Assistant Professor of Medicine
Weill Cornell Medical College
New York, New York

Consulting Agreements: Amgen Inc, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Cogent Biosciences, Elevar Therapeutics, Exelixis Inc, Jazz Pharmaceuticals Inc, Merck, RayzeBio Inc, Servier Pharmaceuticals LLC; Data and Safety Monitoring Boards/Committees: Merck.

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, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, 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, 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, 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 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 Incyte Corporation and Jazz Pharmaceuticals Inc.

Release date: August 2025
Expiration date: August 2026

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

Ayasun R et al. The role of HER2 status in the biliary tract cancers. Cancers (Basel) 2023;15(9). Abstract

Bekaii-Saab TS et al. FIGHT-302: First-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol 2020;16(30):2385-99. Abstract

Delaunay B et al. PemiBil: Efficacy and safety of pemigatinib in advanced cholangiocarcinoma with FGFR2 fusions/rearrangements in real-world, results of multicentric French cohort from ACABI consortium. ESMO 2023;Abstract 121P.

Fan J et al. A phase 3, randomized study of adjuvant rilvegostomig plus chemotherapy in resected biliary tract cancer: ARTEMIDE-Biliary01. ASCO 2024;Abstract TPS4199.

Finn R et al. Three-year follow-up data from KEYNOTE-966: Pembrolizumab (pembro) plus gemcitabine and cisplatin (gem/cis) compared with gem/cis alone for patients (pts) with advanced biliary tract cancer (BTC). ASCO 2024;Abstract 4093.

Galdy S et al. HER2/HER3 pathway in biliary tract malignancies; systematic review and meta-analysis: A potential therapeutic target? Cancer Metastasis Rev 2017;36(1):141-57. Abstract

Goyal L et al. Futibatinib for FGFR2-rearranged intrahepatic cholangiocarcinoma. N Engl J Med 2023;388(3):228-39. Abstract

Harding JJ et al. HERIZON-BTC-302: A phase 3 study of zanidatamab with standard-of-care (SOC) therapy vs SOC alone for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced/metastatic biliary tract cancer (BTC). Gastrointestinal Cancers Symposium 2025;Abstract TPS648.

Ikeda M et al. Randomized, open-label, multicenter, phase III study of trastuzumab deruxtecan (T-DXd) with rilvegostomig vs standard of care (SOC) in first-line, human epidermal growth factor receptor 2 (HER2)-expressing, locally advanced or metastatic (LA/m) biliary tract cancer (BTC): DESTINY-BTC01. ESMO Asia Congress 2024;Abstract 261TiP.

Jacobi O et al. ERBB2 pathway in biliary tract carcinoma: Clinical implications of a targetable pathway. Oncol Res Treat 2021;44(1-2):20-7. Abstract

Javle M et al. Biliary cancer: Utility of next-generation sequencing for clinical management. Cancer 2016;122(24):3838-47. Abstract

Kehmann L et al. Evolving therapeutic landscape of advanced biliary tract cancer: From chemotherapy to molecular targets. ESMO Open 2024;9(10). Abstract

Kim RD et al. Survival outcomes for zanidatamab-hrii compared to chemotherapy in previously treated HER2-positive (IHC3+) biliary tract cancer (BTC): HERIZON-BTC-01 vs a real-world (RW) external control arm (ECA). ASCO 2025;Abstract 4101.

Lee CK et al. Impact of HER2-positivity on prognosis and targeted therapeutic outcomes in advanced biliary tract cancer. Gastrointestinal Cancers Symposium 2025;Abstract 629.

Li C et al. A phase IIa clinical trial of first-line cyclical therapy alternating gemcitabine, cisplatin, and durvalumab with pemigatinib for advanced biliary tract cancers with FGFR2-alterations. Gastrointestinal Cancers Symposium 2025;Abstract TPS645.

Meric-Bernstam F et al. Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: Primary results from the DESTINY-PanTumor02 phase II trial. J Clin Oncol 2024;42(1):47-58. Abstract

Oh D-Y et al. Antitumour activity and safety of first-line zanidatamab + cisplatin-gemcitabine in patients with HER2-expressing biliary tract cancer (BTC). ESMO GI 2025;Abstract 319P.

Oh D-Y et al. Three-year survival, safety and extended long-term survivor (eLTS) analysis from the phase III TOPAZ-1 study of durvalumab (D) plus chemotherapy in biliary tract cancer (BTC). ESMO GI 2024;Abstract 279MO.

Oh D-Y et al. Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-expressing biliary tract cancer (BTC) and pancreatic cancer (PC): Outcomes from DESTINY-PanTumor02 (DP-02). ASCO 2024;Abstract 4090.

Pant S et al. Zanidatamab in previously-treated HER2-positive (HER2+) biliary tract cancer (BTC): Overall survival (OS) and longer follow-up from the phase 2b HERIZON-BTC-01 study. ASCO 2024;Abstract 4091.

Paz-Ares L et al. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): A randomised, multicentre, open-label, phase 3 trial. Lancet 2025;405(10495):2129-43. Abstract

Paz-Ares LG et al. Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial. ASCO 2025;Abstract 8006.

Porębska N et al. Targeting cellular trafficking of fibroblast growth factor receptors as a strategy for selective cancer treatment. J Clin Med 2018;8(1):7. Abstract

Rha SY et al. Zanidatamab (Zani) + chemotherapy (CT) in first-line (1L) human epidermal growth factor receptor 2-positive (HER2+) advanced/metastatic colorectal cancer (mCRC). ESMO 2024;Abstract 516MO.

Smit EF et al. Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-mutated metastatic non-small cell lung cancer (NSCLC): Interim results of DESTINY-Lung01. ASCO 2020;Abstract 9504.

Søreide K et al. Biliary tract cancer. Eur J Surg Oncol 2025;51(6):108489. Abstract

Theocharopoulos C et al. HER2-targeted therapies: Unraveling their role in biliary tract cancers. Crit Rev Oncol Hematol 2025;208:104655. Abstract

Trueman S et al. Zanidatamab dose optimization in patients with HER2-positive biliary tract cancer (BTC). Gastrointestinal Cancers Symposium 2025;Abstract 546.

Uzunparmak B et al. HER2-low expression in patients with advanced or metastatic solid tumors. Ann Oncol 2023;34(11):1035-46. Abstract

Vogel A et al. An open-label study of pemigatinib in cholangiocarcinoma: Final results from FIGHT-202. ESMO Open 2024;9(6). Abstract