Combination Immunotherapy Header

The future of immuno-oncology drug development is positioned in combination therapies, where immunotherapy modalities are tested in rational combinations with other immunotherapies or targeted therapies for synergistic effects. Combination immunotherapy promises to deliver long-term survival benefits that may be unavailable with current approaches. The Inaugural Combination Immunotherapy meeting will explore the most effective combinations of immunotherapy with chemotherapy, other immunotherapy or targeted therapy. Coverage will include understanding the mechanism of action, managing toxicity, strategies to design synergistic combinations, biomarker development and case studies of ongoing combination immunotherapy studies from the leading researchers in industry and academia.

Final Agenda

Wednesday, May 3

12:00 pm Conference Registration

12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:30 Dessert Break in the Exhibit Hall with Poster Viewing

 

Plenary Keynotes

2:00 Chairperson’s Opening Remarks

Robert Iannone, M.D., Senior Vice President & Head, Immuno-Oncology, Global Medicines Development, AstraZeneca

2:05 Immunophenotyping to Differentiate Responder and Non-Responder Patients in Cancer Immunotherapy

George Poste, D.V.M., Ph.D., Chief Scientist, Complex Adaptive Systems, Arizona State University

The clinical benefits of immune checkpoint inhibitors in a variety of malignancies are unprecedented. Unfortunately, the level of positive therapeutic response is not consistent across different tumor classes and even in responsive tumor lineages non-responders still dominate. The need for comprehensive immunophenotyping to identify the mechanisms underlying these differential reponses and better predict responder patients is an urgent clinical and economic imperative.

2:30 Rational Combinations with PD-L1 Antagonists

Robert Iannone, M.D., Senior Vice President & Head, Immuno-Oncology, Global Medicines Development, AstraZeneca

2:55 Non-Clinical Approaches to Predict Single Agent vs. Combination Value and Clinical Development Strategies for Emerging Cancer Immunotherapies

James Smothers, Ph.D., Senior Director & Head, Discovery, Immuno-Oncology & Combinations DPU, GlaxoSmithKline

A rapidly growing number of immunotherapy treatments for cancer have entered clinical trials and are being evaluated for both single agent and combination therapeutic value. Currently approved or mature Phase III evaluations of immuno-oncology treatments are largely limited to strategies that employ either autologous T-cell treatments or use of monoclonal antibodies (mAbs) to block T-cell checkpoints of either activation or exhaustion. Other modalities being explored in late phase preclinical and early clinical development include agonistic mAbs that modulate healthy immune cell populations, small molecule chemistries to inhibit or drive enzymatic function, and other emerging or reconsidered approaches to experimental medicine design. Non-clinical research studies historically support preclinical development and regulatory submission satisfaction and provide critical support of early clinical development hypotheses and clinical trial design including managing expectations of single agent efficacy or setting strategic vision for combination value through biology synergies. Moreover, following early clinical development milestones, an experimental medicine requires ongoing translational review of the clinical readouts beyond efficacy which in turn requires additional non-clinical analyses and experimental execution to drive results-based decision making and data-informed design of late stage clinical trials in anticipation and hope of drug approvals. Examples of non-clinical studies to support all of these activities will be reviewed including choice of experimental models and design.

3:20 Refreshment Break in the Exhibit Hall with Poster Viewing

 

Biomarkers for Combination Immunotherapy

4:10 Chairperson’s Opening Remarks

David Kaufman, M.D., Ph.D., Executive Director, Translational Immunology & Oncology, Merck Research Laboratories

4:15 Evaluating the Role of Precision Medicine in Immuno-Oncology

David Kaufman, M.D., Ph.D., Executive Director, Translational Immunology & Oncology, Merck Research Laboratories

This presentation will cover: 1) examining the clinical utility of PD-L1 expression in classifying responders to immuno-oncology therapeutics, 2) evaluating novel biomarkers with the potential to describe fundamental features of tumor immunobiology across tumor types, and 3) forming a comprehensive biomarker signature approach – incorporating DNA and RNA-based biomarkers to determine patient treatment approaches in the era of combination cancer immunotherapy.

4:40 Driver-MapTM Targeted RNA Expression Profiling Solution: The Sensitivity of RT-PCR Combined with the Throughput and Range of NGS

Paul Diehl, Ph.D., COO, Cellecta



5:10 Biomarkers for Combination Immunotherapy

Jeffrey Wallin, Ph.D., Group Leader/Senior Scientist, Oncology Biomarker Development, Genentech

The immune system’s ability to detect and destroy abnormal cells is the foundation of cancer immunotherapy. Activation of anti-tumor immunity by immune checkpoint blockade has demonstrated efficacy in a variety of cancers and although durable responses have been observed, combination approaches will be required to extend this benefit beyond a subset of patients. This talk will focus on biomarkers, with specific examples from atezolizumab (anti-PD-L1) clinical combination studies.

5:35 Developing Immunotherapy and Biomarkers in Prostate Cancer: Challenges and Strategies

Ravi Madan, M.D., Clinical Director, Genitourinary Malignancies Branch, National Cancer Institute, National Institutes of Health

There are many studies investigating immunotherapy combinations in prostate cancer, including androgen deprivation therapy, anti-androgen therapy, chemotherapy and radiopharmaceuticals. Emerging data suggests the potential for the development immune biomarker platforms and possibly even imaging biomarkers. These preliminary findings may have relevance in many cancers beyond prostate cancer.

5:45 Short Course and ThinkTank Registration

 

6:15 - 9:15 Dinner Executive ThinkTank*

SC6: Complementary Diagnostics

6:15 - 9:15 Dinner Short Course*

SC7: Immune Monitoring in Cancer

*Separate registration required

Thursday, May 4

8:30 am Morning Coffee

 

Strategies for Immunotherapy Combinations

 9:00 Chairperson’s Remarks

Timothy Yap, M.D., Ph.D., Associate Professor, Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center

 9:05 The Art of Immuno-Oncology: Overcome the Barriers to Personalized Cancer Medicine

Zhen Su, M.D., MBA, Vice President & Head of Global Medical Affairs – Oncology, EMD Serono

Recent advancement in immuno-oncology has significantly changed oncology practice worldwide. The clinical benefit of immune checkpoint blockades has been shown in multiple tumor settings especially the “hot tumors” with significant T cell infiltration. However, due to rapid clinical development of these agents, there is a paucity of knowledge of how to integrate this new class of treatment into the treatment algorism in daily practice. In addition, the complexity and challenges in biomarker development to assist patient selection for the checkpoint blockade also complicated the adaptation of such treatment in the real world setting. A deep dive of recent data and holistic approach in clinical setting is warranted to overcome the barriers to integrate immune-oncology into the personalized cancer medicine era.

 9:30 Rational Design of Immunotherapy Combinations

Carol O’Hear, M.D., Ph.D., Associate Medical Director, Cancer Immunotherapy, Genentech

The cancer immunity cycle provides a framework to understand how alterations in the tumor micro-environment can be targeted to enhance clinical response to immunotherapy. In addition, biomarker data obtained through clinical trials has added to our understanding of how to optimize combination immunotherapy. Utilization of this information allows a patient’s immune deficiencies to be targeted rationally to maximize opportunities for clinical success.

9:55 Rational IO Combinations Based on the Presence or Absence of Tumor T Cell Inflammation

Jason Luke, M.D., Assistant Professor, Medicine, Melanoma and Developmental Therapeutics Clinics, University of Chicago

A subset of patients with cancer have a spontaneous anti-tumor immune response and T cell infiltration into tumor sites. The presence of this T cell-inflamed or non-inflamed tumor microenvironment can be most robustly described via gene expression profiling and can be used for IO combination target identification stratified by the presence or absence of T cell inflammation. This model and rationale IO combination therapies will be explored.

10:20 Networking Coffee Break

 

Immune Modulators and Combinations

10:45 PD-1 Antibody, a Broad Spectrum Antineoplastic Therapy, Is Transforming Management of a Number of Cancers

Roy D. Baynes, M.D., Ph.D., Senior Vice President and Head, Global Clinical Development, CMO, Merck Research Laboratories

In an efficient and biologically targeted screening Phase II program, pembrolizumab has shown activity across more than twenty different cancers. Randomized studies have shown survival benefit for pembrolizumab over standard of care in metastatic malignant melanoma, metastatic non-small cell lung cancer and 2nd line treatment of metastatic bladder cancer. Pembrolizumab is being explored in a number of different combination regimens, many of which are showing promising initial activity that has led to conducting randomized studies.

11:10 Immuno-Oncology Combinations: Raising the Tail of the Survival Curve

Timothy Yap, M.D., Ph.D., Associate Professor, Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center

There have been exponential gains in immuno-oncology in recent times through the development of immune checkpoint inhibitors. Already approved by the FDA for selected cancers, immune checkpoint inhibitors also appear to have significant antitumor activity in multiple other tumor types. Nevertheless, not all patients benefit, and efforts should thus now focus on improving the efficacy of immunotherapy through the use of combination approaches and predictive biomarkers of response and resistance.

11:35 Clinical Activity of PDR001, an Anti-PD-1 Antibody, in Advanced Solid Tumors

Jennifer Mataraza, Ph.D., Senior Investigator II, Exploratory Immune Oncology, Novartis Institutes of Biomedical Research

PDR001 is a humanized anti-PD-1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2 to PD-1. PDR001 binds to PD-1 with high affinity and inhibits the biological activity of PD-1. I will discuss patient case studies from our PDR001 Phase I FIH trial. In addition, I will highlight some of our early biomarker data from our PDR001 trials.

12:00 pm Novel Approaches for the Combination Immunotherapy of Cancer

Jon Wigginton, M.D., Senior Vice President, Clinical Development & CMO, MacroGenics

 

 

12:25  Session Break 

Mitra Biotech12:35 Luncheon Presentation: A Novel Phenotypic Platform for Predicting Tumor Response in Drug Development 

Mark Paris, Ph.D., Technical Liaison, Mitra Biotech

 

Combining Immunotherapy with Other Modalities

1:40 Chairperson’s Opening Remarks

1:45 Opportunities to Combine Targeted and Conventional Cancer Therapy with Immunotherapy

Philip Gotwals, Ph.D., Executive Director, Exploratory Immuno-Oncology, Novartis Institutes for BioMedical Research

Research in cancer therapeutics has largely focused on two distinct, independent lines of inquiry: efforts to understand the underlying cell autonomous, genetic drivers of tumorigenesis, and exploration of the mechanisms of protective tumor immunity. The integration of these potentially complementary research fields provides new opportunities to improve cancer treatments. This presentation will review insights into the effects of targeted therapies on the induction of anti-tumor immunity that may help advance the design of therapeutic combination strategies.

2:10 Combination Immunotherapy with Chemotherapy – Early Results from Clinical Trials

Glen J. Weiss, M.D., MBA, Director, Clinical Research and Phase I & II Clinical Trials, Cancer Treatment Centers of America, Goodyear, AZ

Recently, a number of new immunotherapies are available for clinical use for treating advanced cancer. A small portion of patients treated with single agent monoclonal antibody immunotherapy do experience an impressive durable response. Likely the next wave of approvals will involve combination therapy involving chemotherapy, targeted therapy, or additional immune-modulating agents. This lecture will highlight some of the current data on combination immunotherapy that have been evaluated in advanced cancers.

 2:35 Close of Conference