Wednesday, May 18
11:00 am Conference Registration
12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
12:45 Dessert Break in the Exhibit Hall with Poster Viewing
1:30 Chairperson’s Opening Remarks
Marisa Dolled-Filhart, Ph.D., Director, Pathology and Companion Diagnostics, Translational Biomarkers, Merck
1:35 Development of PD-L1 as a Companion Diagnostic for Pembrolizumab
Marisa Dolled-Filhart, Ph.D., Director, Pathology and Companion Diagnostics, Translational Biomarkers, Merck
The rapid clinical development of pembrolizumab required rapid development of a PD-L1 immunohistochemistry assay. This talk will focus on Merck’s determination of whether or not PD-L1 was a predictive biomarker, use of the assay to enrich in clinical trials, and partnership to develop the assay as a companion diagnostic, which was subsequently approved by the FDA.
2:00 PD-L1: A Complementary Diagnostic for Nivolumab Checkpoint Therapy in Advanced Cancer
Julie Dixon, Ph.D., Group Director, Global Regulatory Sciences, Bristol-Myers Squibb
2:25 Comparing CDx Tests: What’s a Pathologist to Do?
David Rimm, M.D., Ph.D., Professor, Pathology, Yale University
2:50 From Eligibility to CDx: Developing and Implementing Effective Biomarker Strategies for Immuno-Oncology Trials
Patrice Hugo, Ph.D., CSO, Q² Solutions
Patrick Hurban, Ph.D., Senior Director and Global Head, Genomic Development/Esoteric Assays, Q² Solutions
By capitalizing on fundamental cancer and immunology research, Immuno-Oncology (I-O) has led to exciting breakthroughs. A deep understanding of the tumor and the anti-tumor immune response is needed to fully exploit this strategy, requiring a fresh perspective on biomarker strategies and a comprehensive toolkit for biomarker testing. I-O trials face particular challenges, and we will discuss how we have engaged Pharma and focused critical tools—anatomic pathology, flow cytometry, and genomics—on these challenges, as well as how we have leveraged this knowledge to facilitate transitioning to companion diagnostic development.
3:20 Refreshment Break in the Exhibit Hall with Poster Viewing
4:25 Diagnostic Strategies for Cancer Immune Therapies
Andy Williams, Ph.D., Companion Diagnostics Group Leader, Cancer Immune Therapies, Genentech
Current and future opportunities for diagnostics for cancer immune therapies will be covered. This will include companion diagnostics as well as other informative tests.
4:50 FDA Regulatory Review of Companion Diagnostics in Cancer Immunotherapy
Shyam Kalavar, MPH, CT(ASCP), Scientific Reviewer, Diagnostic Devices, Center for Devices and Radiological Health, US Food and Drug Administration
This talk will focus on regulatory considerations for companion diagnostics that guide cancer immunotherapy. The talk will cover issues related to the use of diagnostics in biomarker-related drug trials with a focus on immunohistochemistry assays. FDA regulatory review of these diagnostics for approval purposes will also be discussed.
Thursday, May 19
7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:25 Chairperson’s Remarks
Roy Baynes, M.D., Ph.D., Senior Vice President and Head, Global Clinical Development, Merck Research Laboratories
8:30 Integration of Cancer Immunotherapy into Precision Medicine
Zhen Su, M.D., MBA, Senior Vice President, Global Head of Medical Affairs Oncology, EMD Serono
8:55 PD-1 Antibody – A Broad Spectrum Anti-Cancer Therapeutic
Roy Baynes, M.D., Ph.D., Senior Vice President and Head, Global Clinical Development, Merck Research Laboratories
An adaptive Phase 1 study enabled rapid development and approval of pembrolizumab, a humanized anti PD-1 monoclonal antibody, for patients with metastatic melanoma and non-small cell lung cancer along with a companion diagnostic. An efficient Phase II program informed by various big data sets has led to the identification of meaningful activity in more than 20 different cancer types. An extensive array of Phase III studies is being conducted across these cancer types. Further refinements are underway to identify patients most likely to benefit from monotherapy and those for whom additional therapeutic strategies should be considered.
9:20 Supporting CAR T Trials in GBM through NGS: Patient Selection and Monitoring
Jennifer J.D. Morrissette, Ph.D., Assistant Professor, Clinical Pathology & Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania
9:45 The Emergence of icScore™ as a Novel Immune-Based Approach for Monitoring Cancer Patients
Henry Hepburne-Scott, Ph.D., Director, Business Development, Serametrix
• Cancer immunotherapies offer great promise but some patients fail to respond
• Immune-based biomarker assays can help predict clinical response to this emerging drug class
• Serametrix has developed icScore™, an immune monitoring system designed for cancer patients
10:15 Networking Coffee Break
10:45 Drivers, Checkpoints and other Obstacles to Oncology Biomarker Development
Nicholas C. Dracopoli, Ph.D., Vice President & Head, Translational Research, Oncology, Janssen Research & Development
11:10 Talk Title to be Announced
Jakob Dupont, M.D., Senior Vice President & CMO, OncoMed Pharmaceuticals
11:35 Predictive Biomarkers for Cytokine Release Syndrome Following Chimeric Antigen Receptor Therapy for Acute Lymphoblastic Leukemia
Simon F. Lacey, Ph.D., Director, The Center for Cellular Immunotherapies Translational and Correlative Studies Laboratory, Center for Advanced Cell Therapies, University of Pennsylvania
Chimeric antigen receptor-equipped T (CART) cells have shown remarkable efficiency in targeting B cell malignancies. Often, this therapy is accompanied by severe cytokine release syndrome. In my talk I will highlight the biology of CART cell therapy and describe our latest findings in biomarkers associated with and predictive of cytokine release syndrome.
12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:00 Chairperson’s Remarks
Andrey Loboda, Ph.D., Director, Systems Immuno-Oncology Analytics, Genetics and Pharmacogenomics, Merck Research Labs
1:05 Biomarker Analysis for Immuno-Oncology, the Convergence of Immunology, Oncology and “Omics” Technologies
Randi Isaacs, M.D., Clinical Site Head, Translational Clinical Oncology, Novartis Institutes for BioMedical Research
1:30 Molecular Epidemiology Analysis of Immune Activation across a Large Cohort of Human Tumors Accelerates Clinical Development of the Anti-PD1 Inhibitor Pembrolizumab
Andrey Loboda, Ph.D., Director, Systems Immuno-Oncology Analytics, Genetics and Pharmacogenomics, Merck Research Labs
I will talk about development of gene expression biomarkers of response anti-PD1 and explore the prevalence of biomarker-positive tumors across large cohorts of human tumor gene expression profiles. The impact it had on the clinical development of anti-PD1 inhibitor pembrolizumab will be discussed.
1:55 Deep Profiling of Tumor Infiltrating Immune Cells with Flow Cytometry and Correlation with Clinical Outcome
Adil Daud, M.D., Professor, Hematology/Oncology, University of California, San Francisco; Director, Melanoma Clinical Research, UCSF Helen Diller Family Comprehensive Cancer Center
The development of biomarkers for PD-1 inhibitors is critical as ~40-50% of patients will not benefit in melanoma. PDL-1 immunohistochemistry has been studied most extensively as a biomarker but is limited in both sensitivity and specificity. We have developed a novel biomarker that determines the fraction of “exhausted” PD-1 /CTLA4 dual positive CD8+ T cells within tumors. In addition, we determine the T reg and DC population characteristics within tumors and use these to define the immune milieu within tumors.
2:20 Close of Conference