Friday, January 24, 2020, San Francisco, California, 6:00 PM – 8:00 PM

Beyond the Guidelines: Clinical Investigator Perspectives on the Management of Hepatobiliary Cancers

Part 2 of a 2-Part CME Symposia Series

InterContinental San Francisco
888 Howard Street
San Francisco, CA 94103
Hotel Phone: (415) 616-6500

5:30 PM – 6:00 PM — Registration and Dinner Buffet
6:00 PM – 8:00 PM — Educational Meeting

Meeting Room
Grand Ballroom (Third Floor)

There is no registration fee for this event. However, preregistration is advised as seating is limited.  
Ghassan Abou-Alfa, MD
Memorial Sloan Kettering Cancer Center
New York, New York

Anthony El-Khoueiry, MD
Associate Professor of Clinical Medicine
Medical Director of Clinical Investigations
Support Office
Phase I Program Director
USC Norris Comprehensive Cancer Center
Los Angeles, California

Richard S Finn, MD
Professor of Clinical Medicine
Division of Hematology/Oncology
David Geffen School of Medicine at UCLA
Director, Signal Transduction and
Therapeutics Program
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California

Professor Dr Peter R Galle, PhD
I Dept of Internal Medicine
University Medical Center Mainz
Mainz, Germany

Andrew X Zhu, MD, PhD
Director, Jiahui International Cancer Center
Shanghai, China
Director Emeritus, Liver Cancer Research
Massachusetts General Hospital Cancer Center
Boston, Massachusetts

Neil Love, MD
Research To Practice
Miami, Florida

Not an official event of the 2020 Gastrointestinal Cancers Symposium. Not sponsored, endorsed, or accredited by any of the cosponsoring organizations of the 2020 Gastrointestinal Cancers Symposium.

Meeting Agenda and Format

To begin each module, results of interactive audience polling using networked iPads will be juxtaposed with the findings from a survey comprising case-based and related management questions completed by 25 clinical investigators prior to the meeting. Each faculty member will then deliver a presentation reviewing recently published research data and ongoing clinical trials related to the topics and questions addressed via the surveys. After each presentation, moderated panel discussion will take place to generate other relevant perspectives and dialogue.

MODULE 1: First-Line Systemic Therapy for Patients with Unresectable Hepatocellular Carcinoma (HCC) — Dr Finn

  • Design of, eligibility criteria for and key efficacy findings from the Phase III REFLECT study comparing lenvatinib to sorafenib as first-line therapy for unresectable HCC
  • Frequency of treatment-related side effects (eg, hypertension, hand-foot syndrome, decreased appetite, proteinuria), dose delays and discontinuations associated with lenvatinib and sorafenib in the REFLECT trial
  • FDA approval of lenvatinib as first-line therapy for unresectable HCC; patient selection for its use in routine practice
  • Results from the Phase III CheckMate 459 trial evaluating nivolumab as first-line treatment for advanced HCC; clinical and research implications
  • Biologic rationale for, early trial data with and FDA breakthrough therapy designation for atezolizumab/bevacizumab as first-line therapy for advanced HCC
  • Available efficacy and safety results from the Phase III IMbrave150 trial documenting the benefit of atezolizumab in combination with bevacizumab as first-line therapy for advanced HCC

MODULE 2: Available Data with and Patient Selection for Anti-angiogenic Therapy for Progressive Metastatic HCC — Dr Zhu

  • Key factors (eg, performance status, liver function, alpha-fetoprotein [AFP] level, prior therapy) influencing the selection of treatment for patients who experience disease progression after first-line therapy
  • Design, eligibility criteria and key efficacy and safety outcomes from the Phase III RESORCE trial comparing regorafenib to best supportive care for patients with disease progression on sorafenib; optimal starting dose of regorafenib as second-line therapy
  • Major efficacy and tolerability findings from the Phase III CELESTIAL trial comparing cabozantinib to placebo for patients with HCC who have experienced disease progression on sorafenib; outcomes for patients who had received more than 1 systemic anticancer regimen
  • FDA approval and off-protocol role of cabozantinib in the management of progressive HCC
  • Clinical significance and frequency of elevated AFP in patients with advanced HCC; proportion of individuals with advanced HCC with AFP-high (≥400 ng/mL) disease
  • Key findings from the Phase III REACH-2 study of ramucirumab for patients with progressive HCC and elevated AFP levels; recent FDA approval of ramucirumab and patient selection for this approach

MODULE 3: Published Data with and Appropriate Integration of Immune Checkpoint Inhibitors into the Care of Patients with Progressive Metastatic HCC — Dr El-Khoueiry

  • Clinical factors guiding the use of immunotherapy versus targeted therapy for patients experiencing disease progression on first-line sorafenib or lenvatinib (eg, Child-Pugh score, disease-free interval, tyrosine kinase inhibitor tolerability)
  • Long-term efficacy and safety from the Phase I/II CheckMate 040 study of nivolumab for patients with advanced HCC who refused or experienced progressive disease on sorafenib
  • Key efficacy and safety results from the Phase II KEYNOTE-224 trial evaluating pembrolizumab for patients with advanced HCC whose disease progressed on or who could not tolerate sorafenib; accelerated FDA approval of pembrolizumab for patients with HCC who have previously received sorafenib
  • Available data from the Phase III KEYNOTE-240 trial evaluating pembrolizumab versus best supportive care for patients with advanced HCC after disease progression on sorafenib; effect, if any, on future use
  • Autoimmune toxicity profile of immune checkpoint inhibitors in patients with HCC compared to those with other diseases; special considerations for patients with extensive liver disease, hepatitis B or C, prior liver transplant, et cetera

MODULE 4: Novel Approaches Under Investigation for Advanced HCC — Prof Galle

  • Results from the Phase Ib KEYNOTE-524 trial/Study 116 evaluating pembrolizumab in combination with lenvatinib as first-line treatment for advanced unresectable HCC not amenable to locoregional treatment; FDA breakthrough therapy designation and developmental plans
  • Available safety and efficacy findings with and ongoing evaluation of combined anti-PD-1/PD-L1 and anti-CTLA-4 antibodies in HCC (eg, nivolumab/ipilimumab, durvalumab/tremelimumab)
  • FDA acceptance of supplemental Biologics License Application and priority review status for nivolumab with ipilimumab for advanced HCC previously treated with sorafenib
  • Active Phase III trials attempting to improve outcomes over standard biologic therapy for patients with newly diagnosed, advanced HCC (eg, LEAP-002, COSMIC-312, HIMALAYA)
  • Other novel agents and strategies under late-stage investigation in advanced HCC

MODULE 5: Current and Future Management of Advanced Biliary Tract Cancers — Dr Abou-Alfa

  • Heterogeneity of advanced biliary tract cancers; variability of clinical presentation, outcomes and available treatments based on primary tumor location (intrahepatic bile ducts versus extrahepatic bile ducts versus gallbladder)
  • Spectrum of molecular alterations among advanced biliary tract cancers; utility of next-generation sequencing to identify actionable molecular abnormalities
  • Frequency of IDH mutations in patients with advanced cholangiocarcinoma and early data with novel agents targeting these abnormalities
  • Results from the Phase III ClarIDHy study evaluating the IDH1 inhibitor ivosidenib for patients with previously treated cholangiocarcinoma with an IDH1 mutation
  • Biologic rationale supporting FGFR inhibition as a rational therapeutic strategy for patients with metastatic cholangiocarcinoma
  • Findings from the Phase II FIGHT-202 trial of the selective FGFR inhibitor pemigatinib for patients with advanced or surgically unresectable cholangiocarcinoma and an FGFR2 translocation for whom at least 1 previous treatment had failed; FDA acceptance for priority review of pemigatinib and potential role in clinical practice
  • Design, eligibility criteria and estimated completion date for the Phase III FIGHT-302 study of pemigatinib versus gemcitabine/cisplatin as first-line therapy for unresectable or metastatic cholangiocarcinoma with an FGFR2 rearrangement
  • Available clinical trial experience with other targeted therapeutic approaches (eg, infigratinib, erdafitinib, dabrafenib/trametinib) and anti-PD-1/PD-L1 antibodies in advanced biliary tract cancers

Target Audience
This activity is intended for medical oncologists, hematology-oncology fellows, surgeons and other healthcare providers involved in the treatment of gastrointestinal cancers.

Learning Objectives
At the conclusion of this activity, participants should be able to:

  • Develop evidence-based strategies to properly diagnose and stage hepatocellular carcinoma (HCC), and use this information to counsel patients regarding long-term prognosis.
  • Consider age, performance status, degree of liver function and other clinical factors in the selection of up-front therapy for patients with newly diagnosed unresectable or metastatic HCC.
  • Acknowledge the available Phase III data with and the FDA approvals of regorafenib and cabozantinib for progressive HCC, and discern how these agents can be optimally integrated into the clinical care of patients.
  • Develop an understanding of the biologic rationale for, available clinical data with and FDA approvals of nivolumab and pembrolizumab for the treatment of progressive HCC, and identify patients appropriate for therapy with these agents.
  • Understand published Phase III data with and the rationale for investigation of ramucirumab for patients with advanced HCC and elevated alpha-fetoprotein who have experienced disease progression after treatment with sorafenib, and use this information to appropriately integrate ramucirumab into current treatment algorithms.
  • Counsel patients regarding the incidence and manifestation of side effects and toxicities associated with existing and emerging targeted agents and immunotherapeutic approaches in the management of advanced HCC.
  • Recall available and emerging data with other investigational agents and strategies currently in clinical testing for HCC, and where applicable, refer eligible patients for trial participation or other expanded access programs.
  • Consider available clinical research findings and the perspectives of gastrointestinal cancer investigators on the formation of evidence-based therapeutic algorithms for the management of unresectable and metastatic biliary tract cancers.
  • Recognize the molecular heterogeneity of biliary tract cancers, appreciate the biologic rationale for efforts to exploit documented abnormalities, and use this information to identify patients who may be eligible for studies evaluating novel targeted agents.

CME Credit Form
A CME credit form will be given to each participant at the conclusion of the activity.

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
Research To Practice designates this live activity for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosure Policy
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. Financial disclosures will be provided in meeting course materials.

This activity is supported by educational grants from Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb Company, Exelixis Inc, Genentech, Incyte Corporation and Lilly.

InterContinental San Francisco
888 Howard Street
San Francisco, CA 94103
Hotel Phone: (415) 616-6500

Meeting Room
Grand Ballroom (Third Floor)

The InterContinental San Francisco hotel is adjacent to the Moscone Center, where the 2020 Gastrointestinal Cancers Symposium is taking place.


Thank you for your interest in our CME program. At this time online preregistration is closed for this event. SEATS ARE STILL AVAILABLE FOR THIS SESSION.  Our ONSITE REGISTRATION DESK will be open starting at 5:30 PM on Friday January 24th.  If you are interested in attending, please visit our registration desk located outside the Grand Ballroom (3rd Floor) of the InterContinental San Francisco hotel (888 Howard Street) near the Moscone Convention Center. 

We will accept onsite registrations, with priority given to clinicians in practice, on a first come, first served basis. Please note, onsite registration does not guarantee participation in the session or meal service.

If you have any questions, please feel free to contact us via email at or call (800) 233-6153.

Registration for this event is independent of registration for the Gastrointestinal Cancers Symposium.