Friday, February 9, 2018, San Francisco, California, 7:15 PM – 9:15 PM (Pacific Time)

Cases from the Community: Clinical Investigators Provide Their Perspectives on the Use of Immune Checkpoint Inhibitors in the Management of Actual Patients with Genitourinary Cancers

Send Us A Patient Case For Discussion
Clinicians in practice are invited to submit one or more interesting bladder, renal cell and prostate cancer cases for potential discussion. Simply send a brief video recording of yourself (it can be shot with your cell phone) describing the case, along with any questions you have related to it, to GU2018Cases@ResearchToPractice.com. At the meeting we will use a selection of these video cases to generate discussion and debate among our expert panel.

Location:
San Francisco Marriott Marquis
780 Mission Street
San Francisco, CA 94103
Hotel Phone: (415) 896-1600

Time:
7:00 PM – 7:15 PM (Pacific Time) — Registration
7:15 PM – 9:15 PM (Pacific Time) — Educational Dinner Meeting

Meeting Room:
Yerba Buena Ballroom, Salon 9-15 (Lower B2 Level)

There is no registration fee for this event. However, preregistration is advised as seating is limited.

Faculty:
Charles G Drake, MD, PhD
Professor of Medicine
Co-Director, Cancer Immunotherapy Programs
Columbia University Medical Center
New York, New York

Peter H O’Donnell, MD
Assistant Professor of Medicine
Department of Medicine
The University of Chicago
Chicago, Illinois

Elizabeth R Plimack, MD, MS
Director, Genitourinary Clinical Research
Associate Professor, Department of Hematology/Oncology
Fox Chase Cancer Center, Temple Health
Philadelphia, Pennsylvania

Thomas Powles, MBBS, MRCP, MD
Professor of Urology Oncology
Director of St Bartholomew’s Cancer Centre
Queen Mary University of London
London, United Kingdom

David I Quinn, MBBS, PhD
Medical Director
Norris Cancer Hospital and Clinics
Head, GU Cancer Section
Division of Cancer Medicine and Blood Diseases
USC Norris Comprehensive Cancer Center
Los Angeles, California

Moderator:
Neil Love, MD
Research To Practice
Miami, Florida

Not an official event of the Genitourinary Cancers Symposium. Not sponsored, endorsed, or accredited by any of the cosponsoring organizations of the 2018 Genitourinary Cancers Symposium.

7:00 PM – 7:15 PM (Pacific Time) — Registration
7:15 PM – 9:15 PM (Pacific Time) — Educational Dinner Meeting

Overview
For this CME symposium, 5 genitourinary cancer investigators with a specialized interest in immunotherapy will serve as the faculty, and RTP president and medical oncologist Dr Neil Love will serve as the moderator. Prior to the event, RTP is inviting community-based clinicians to submit challenging cases from their own practices of patients with bladder, renal cell and prostate cancer treated with an immune checkpoint inhibitor for discussion during the event. A number of cases will be presented, and the program agenda will be divided into 5 modules, each of which will feature moderated discussion surrounding selected cases followed by a short, faculty member-led presentation reviewing recent data and ongoing research related to the scenarios in question. To cultivate a more interactive environment, clinician attendees will use iPads® to complete a survey centered on the cases and topics to be discussed. Survey results will be interspersed throughout the event to foster additional discussion and debate among the faculty.

MODULE 1: Biologic Rationale for the Use of Immune Checkpoint Inhibitors in Genitourinary (GU) Cancers and Predictors of Treatment Benefit — Dr Drake

Sample Community Oncologist
Case Presentation

A 56-year-old man presents with left flank pain, and CT scan reveals a large psoas muscle mass involving the left kidney with mediastinal adenopathy. Biopsy reveals metastatic renal cell carcinoma (RCC) with sarcomatoid features, and the patient is started on pazopanib, resulting in a partial response lasting 9 months. Disease progression is then noted with left cervical adenopathy and new lesions in the lungs, and the patient is placed on an anti-PD-1 antibody. After 3 doses the cervical adenopathy has doubled in size with redness and moderate pain, and repeat CT reveals stable disease in the abdomen, pelvis and lungs.

Sample Case Discussion Questions

  • Currently, are there any clinical or biologic factors that can be used to identify patients with GU cancers who are likely to respond to immune checkpoint inhibition?
  • For how long should anti-PD-1/PD-L1 antibodies be administered before benefit is assessed? For example, if a patient has obvious disease progression (new lesions) in the first few weeks of treatment, should therapy be continued?
  • How frequently have you observed pseudoprogression after the initiation of anti-PD-1/PD-L1 therapy, and are there any factors that you generally assess in trying to figure out if a patient’s disease is progressing definitively?
  • How frequently have you observed patients who experience rapid disease progression after the initiation of anti-PD-1/PD-L1 therapy
Faculty Presentation Topics

  • Current understanding of the biology of the immune system and the role of immune checkpoint inhibition in cancer treatment
  • Potential predictors of response to anti-PD-1/PD-L1 antibodies (eg, PD-L1 status, mutational and neoantigen burden, gene expression signatures, T-cell infiltration)
  • Incidence of pseudoprogression in patients receiving immune checkpoint inhibitors; practical strategies to discern pseudoprogression from definitive disease progression
  • Characterization and frequency of hyperprogressive disease in patients receiving anti-PD-1/PD-L1 antibody therapy

MODULE 2: Current and Future Integration of Immune Checkpoint Inhibitors into the Management of Urothelial Bladder Cancer (UBC) — Dr Powles

Sample Community Oncologist
Case Presentation

An 81-year-old woman underwent cystectomy 2 years ago for a T2b muscle-invasive UBC after declining neoadjuvant and adjuvant therapy. She recently presented with bilateral pulmonary nodules, and a biopsy of the lung lesion demonstrated metastatic UBC consistent with the primary. The patient has a performance status (PS) of 1.

Sample Case Discussion Questions

  • What therapy, if any, would you offer this patient? If you were going to offer her cytotoxic therapy, how might you modify the dose or schedule given her age and PS? What have you observed in your own practice with respect to the incidence of side effects with common cytotoxic approaches for older patients, and how does this compare to what might be expected with an immune checkpoint inhibitor?
  • How does the rapidity, likelihood and durability of response with anti-PD-1/PD-L1 antibodies compare to what has been historically achieved with second-line chemotherapy for UBC?
  • What factors affect your selection of a checkpoint inhibitor for patients with UBC who experience disease progression after first-line treatment? Do you feel all 5 of the available anti-PD-1/PD-L1 antibodies are fundamentally the same, or do you believe there are differences that might make one more or less effective than the others?
Faculty Presentation Topics

  • Published clinical trial results with FDA-approved anti-PD-1/PD-L1 antibodies: atezolizumab, avelumab, durvalumab, nivolumab and pembrolizumab
  • Practical application and optimal integration of anti-PD-1/PD-L1 antibodies into current clinical algorithms, including in the first-line setting for patients who are ineligible for cisplatin-based therapy
  • Ongoing evaluation of anti-PD-1/PD-L1 and anti-CTLA-4 combinations; other novel combination strategies under investigation

MODULE 3: Existing and Emerging Role of Anti-PD-1/PD-L1 Antibodies in RCC — Dr Plimack

Sample Community Oncologist
Case Presentation

A 61-year-old man presents with hematuria and mild back pain and is found to have metastatic clear cell RCC to the lungs and bone. Palliative radiation therapy is administered, and the patient is started on sunitinib, which he tolerates well except for slightly abnormal liver function tests that normalize after a dose reduction. The patient achieves stable disease for 4 months but subsequently experiences disease progression in the lungs.

Sample Case Discussion Questions

  • In general, how are you integrating anti-PD-1/PD-L1 antibodies into the management of RCC, and what has been your personal experience with these agents in terms of safety and efficacy?
  • Are there any situations in which you would consider immune checkpoint inhibition as first-line therapy outside of a protocol setting today?
  • What has been observed with respect to the degree of PD-L1 positivity and response to immune checkpoint inhibitors in RCC? Do you believe there is currently any role for assessing this biomarker to help guide decision-making outside of a protocol setting for these patients?
  • Should immune checkpoint inhibitors be administered to patients with RCC and baseline renal insufficiency given that these individuals were excluded from some of the clinical trials?
Faculty Presentation Topics

  • Available safety and efficacy data with anti-PD-1/PD-L1 monotherapy in RCC
  • Biologic rationale for and available and emerging research data with anti-PD-1/PD-L1 antibodies in combination with targeted agents (eg, IMmotion150/151, JAVELIN Renal 100 trials); additional ongoing Phase III trials (eg, JAVELIN Renal 101, KEYNOTE-426)
  • Results of the CheckMate 214 trial evaluating nivolumab combined with ipilimumab versus sunitinib in untreated advanced RCC; clinical and research implications

MODULE 4: Immune Checkpoint Inhibition in Prostate Cancer — Dr Quinn

Sample Community Oncologist
Case Presentation

A 71-year-old man with asymptomatic metastatic castration-resistant prostate cancer (mCRPC) to the bone and liver receives sipuleucel-T but 14 months later develops progressive disease. He is started on enzalutamide and fares well for 8 months until developing symptoms related to further disease progression. The patient’s mother died of colon cancer in her midfifties.

Sample Case Discussion Questions

  • What would you recommend for this patient at this point outside of a protocol setting?
  • Are there any particular clinical trials evaluating immunotherapeutic approaches that you might prioritize for this patient at this point?
  • From a biologic standpoint is there any reason to believe anti-PD-1/PD-L1 therapy might work better or worse for a patient who fared well on sipuleucel-T?
  • How frequently have you observed high microsatellite instability (MSI) or DNA mismatch repair (MMR) deficiency in patients with prostate cancer? Given the patient’s family history of colon cancer, is there any role for MSI/MMR testing for this man? How, in general, are you approaching this type of assessment for patients with prostate cancer?
Faculty Presentation Topics

  • Frequency of high MSI or MMR deficiency in patients with metastatic prostate cancer; indications for MSI/MMR assessment
  • Potential impact of exposure and development of subsequent resistance to enzalutamide on levels of PD-L1 expression; early data with pembrolizumab in patients with enzalutamide-resistant mCRPC
  • Biologic rationale for and potential role of anti-PD-1/PD-L1 antibodies in combination with other systemic approaches (eg, secondary hormonal therapy, immunotherapy, radium-223 chloride)
  • Ongoing and planned studies of immune checkpoint inhibitors for patients with prostate cancer

MODULE 5: Incidence and Management of Toxicities Associated with Immune Checkpoint Inhibitors; Autoimmune Contraindications to Treatment — Faculty to Be Announced

Sample Community Oncologist
Case Presentation

A 59-year-old man receives neoadjuvant cisplatin/gemcitabine for muscle-invasive UBC. At cystectomy, the patient is found to be in a pathologic complete remission. However, 11 months later biopsy-proven lung metastases are discovered and the patient is started on an anti-PD-L1 antibody. He appears to be responding but has recently developed significant diarrhea accompanied by fatigue.

Sample Case Discussion Questions

  • Is it currently possible to identify which patients are more likely to experience toxicities from immune checkpoint inhibitors?
  • How should dose reductions and/or delays be approached for patients experiencing significant side effects, and are there specific toxicities that warrant permanent discontinuation of therapy?
  • Which preexisting autoimmune diseases, if any, would represent absolute contraindications to an anti-PD-1/PD-L1 antibody for patients with metastatic UBC, RCC or prostate cancer?
  • How much additional toxicity is observed when anti-PD-1/PD-L1 and anti-CTLA-4 antibodies are administered concurrently to patients with GU cancers?
Faculty Presentation Topics

  • Recognition, time course and management of immune-mediated toxicities with the use of anti-PD-1/PD-L1 antibodies in patients with GU cancers
  • Incidence of pneumonitis associated with anti-PD-1/PD-L1 therapy in patients with RCC versus other solid tumors
  • Frequency and severity of immune-mediated adverse events observed in CheckMate 214 and implications for the use of nivolumab/ipilimumab in RCC treatment
  • Autoimmune contraindications to treatment with immunotherapy; clinical experience with the use of checkpoint inhibitors in patients with preexisting autoimmune disorders

Target Audience
This activity has been designed to meet the educational needs of medical oncologists and other allied healthcare professionals involved in the treatment of prostate cancer, urothelial bladder cancer and renal cell carcinoma (RCC).

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

  • Compare and contrast the mechanisms of action, efficacy and safety/toxicity of approved and investigational immunotherapies for the treatment of prostate cancer, RCC and bladder cancer to determine the current and/or potential utility of these agents in clinical practice.
  • Appraise the rationale for and clinical data with approved anti-PD-1 and anti-PD-L1 antibodies in patients with metastatic RCC and bladder cancer, and use this information to select patients for treatment with an immune checkpoint inhibitor.
  • Describe ongoing research to assist in the identification of biomarkers, tumor characteristics or other clinical features that are indicative of response to immune checkpoint inhibitors in patients with genitourinary (GU) cancers.
  • Evaluate typical and atypical patterns of response to immune checkpoint inhibitors in an effort to identify patients who may or may not be benefiting from these agents.
  • Recognize immune-related adverse events and other common side effects associated with approved and developmental immune checkpoint inhibitors, and use this information to develop supportive management plans for patients with GU cancers undergoing treatment with these agents.
  • Consider available and emerging data with investigational anti-PD-1/PD-L1 antibodies alone or in combination with other systemic approaches currently in Phase II/III testing for select GU cancers, and, where applicable, refer eligible patients for trial participation or expanded access programs.

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.

Supporters
This activity is supported by educational grants from Genentech BioOncology and Merck.

San Francisco Marriott Marquis
780 Mission Street
San Francisco, CA 94103
Hotel Phone: (415) 896-1600

Meeting Room:
Yerba Buena Ballroom, Salon 9-15 (Lower B2 Level)

Directions:
The San Francisco Marriott Marquis is located just 2 blocks (less than 0.2 miles) from the Moscone Center.

 

This activity has been designed to meet the educational needs of medical oncologists and other allied healthcare professionals involved in the treatment of prostate cancer, urothelial bladder cancer and renal cell carcinoma.

There is no registration fee for this event. However, preregistration is advised as seating is limited.

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