Experts Review Actual Cases of Patients with Biliary Tract Cancers — Part 1 of 2 — Webinar Video Proceedings

Faculty

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 evaluation of immune checkpoint inhibitors for advanced biliary tract cancers (BTCs), and develop strategies to optimally incorporate anti-PD-1/PD-L1 antibody-based approaches into the care of patients 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 the role of FGFR inhibitors for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement to optimally select and sequence these agents.
• Evaluate available clinical trial findings with HER2-directed therapies for HER2-positive BTCs, and contemplate the current utility of these agents in treatment for appropriately selected patients.
• Recall available and emerging data with investigational agents and strategies currently in clinical testing for BTCs, and as applicable, refer eligible patients for trial participation.

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

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

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation component and a short 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) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation component and a short 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, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
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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/PPGI2025/1/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 conflicts of interest have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

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

John Bridgewater, MD, PhD
Chair, National Cancer Research Institute Upper Gastrointestinal Group
Senior Lecturer, Medical Oncology
UCL Cancer Institute
London, United Kingdom

No relevant conflicts of interest to disclose.

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: AbbVie Inc, ADC Therapeutics, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, Coherus BioSciences, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Hologic Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

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

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

These activities are supported by an educational grant from Jazz Pharmaceuticals Inc.

Release date: February 2025
Expiration date: February 2026

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

Abou-Alfa GK et al. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): A multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2020;21(6):796-807. Abstract

Al Mahmasani L et al. Obesity and biliary tract cancers: Changing epidemiology. Gastrointestinal Cancers Symposium 2025;Abstract 643.

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

Bridgewater JA et al. Global epidemiology trends in biliary tract cancer: A targeted literature review. EMSO GI 2024;Abstract 290P.

Bridgewater JA et al. Phase II results of the porcupine (PORCN) inhibitor zamaporvint (RXC004) in patients with pancreatic and biliary tract cancer. ESMO GI 2024;Abstract 391P.

Bridgewater JA et al. Real-world treatment patterns in patients with biliary tract cancer (BTC): Retrospective chart review survey in Europe (GARNET-2). ESMO 2023;Abstract 125P.

Cowzer D et al. Molecular and clinical determinants of targeted therapy (TT) outcomes in biliary tract cancer (BTC): Analysis of a prospectively maintained next generation sequencing (NGS) biorepository. Gastrointestinal Cancers Symposium 2025;Abstract 555.

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.

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

Harding J 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.

Harding JJ et al. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): A multicentre, single-arm, phase 2b study. Lancet Oncol. 2023 Jul;24(7):772-782. Abstract

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.

Kawamoto Y et al. Niraparib in patients with BRCA-mutated unresectable or recurrent biliary tract, pancreatic and other gastrointestinal cancers: An investigator-initiated phase 2 trial (NIR-B trial). Gastrointestinal Cancers Symposium 2025;Abstract 589.

Kefas J et al. Adjuvant therapy of biliary tract cancers. Ther Adv Med Oncol 2023:15. Abstract

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.

McNamara MG et al. ABC-12: Exploring the microbiome in patients (pts) with advanced biliary tract cancer (BTC) in a first-line study of durvalumab in combination with cisplatin/gemcitabine (cis/gem). ASCO 2023;Abstract TPS4183.

Mercade TM et al. HERIZON-BTC-302: A phase III study of zanidatamab with standard-of-care (SOC) therapy vs SOC alone for first-line (1L) treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced/metastatic biliary tract cancer (BTC). ESMO 2024;Abstract 62TiP.

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

Naleid N et al. Safety and efficacy of anti-HER2 agents in the treatment of biliary tract cancers: A systematic review. Gastrointestinal Cancers Symposium 2025;Abstract 639.

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.

Pant S et al. Results from the pivotal phase (Ph) 2b HERIZON-BTC-01 study: Zanidatamab in previously-treated HER2‑amplified biliary tract cancer (BTC). ASCO 2023;Abstract 4008.

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.

Rushbrook SM et al. British society of gastroenterology guidelines for the diagnosis and management of cholangiocarcinoma. Gut 2023;73(1):16-46. Abstract

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.

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):103488. Abstract

Yoo C et al. Phase 2 trial of bintrafusp alfa as second-line therapy for patients with locally advanced/metastatic biliary tract cancers. Hepatology 2023;78(3):758-70. Abstract

Zhu AX et al. Final overall survival efficacy results of ivosidenib for patients with advanced cholangiocarcinoma with idh1 mutation: The phase 3 randomized clinical ClarIDHy trial. JAMA Oncol 2021;7(11):1669-77. Abstract