Cambridge Healthtech Institute 第2回

Biomarkers for Immuno-Oncology
( がん免疫療法に対応するバイオマーカー )

がん免疫療法の指針となる予測バイオマーカーとコンパニオン診断
2017年8月29-30日 | Sheraton Boston | 米国マサチューセッツ州ボストン

がん免疫療法に対応するバイオマーカーをテーマにしたこのカンファレンスプログラムでは、製薬会社や研究機関に所属するバイオマーカーの専門家が一堂に会し、予測バイオマーカーや予後バイオマーカーを短期間で開発するための手法、臨床試験でのバイオマーカーの利用、コンパニオン診断薬としての可能性などについて議論します。



Final Agenda


TUESDAY, AUGUST 29

12:00 pm Registration

PRECISION IMMUNO-ONCOLOGY: BIOMARKERS FOR PATIENT SELECTION

1:15 Chairperson's Opening Remarks

Robert Anders, M.D., Ph.D., Associate Professor, Pathology, Johns Hopkins University


1:20 KEYNOTE PRESENTATION: Biomarker Strategies for Precision Immune-Oncology

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

1:50 Atezolizumab in Metastatic Triple-Negative Breast Cancer: Clinical and Biomarker Findings

Jakob Dupont, M.D., MA, Vice President, Global Head Breast & Gyn Cancer Development, Genentech, A Member of the Roche Group

2:20 Targeting Immune Responses in Multiple Myeloma

Raphael Clynes, M.D., Ph.D., Group Medical Director & Scientific Director, Human Immunology, Bristol-Myers Squibb

NeoGenomics2:50 Overlap Between Genomic and Immunohistological Immunotherapy Biomarkers

Maher Albitar, MD, SVP, Chief Medical Officer & Director, Research & Development, NeoGenomics Laboratories, Inc.

PD-L1 expression as detected by immunohistochemistry remains the most extensively studied and used biomarker in immunotherapy. However new molecular biomarkers are emerging as potential predictor of response in immunotherapy. This includes tumor mutation burden (TMB), microsatellite instability (MSI), abnormalities in DNA repair genes and others. In addition, combining immunotherapy with targeted therapy is being considered at this time and selecting biomarkers that can predict the efficacy of such combination is becoming a significant unmet need. Data correlating genomic biomarkers with PD-L1 expression as detected by IHC will be presented and discussed.

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


4:00 PLENARY KEYNOTE SESSION

Click here for details

5:30 Welcome Reception in the Exhibit Hall with Poster Viewing

5:30 Dinner Short Course Registration*

SC1: Bioinformatics for Immuno-Oncology and Translational Research

SC2: Microbiome in Immuno-Oncology

*Separate registration required, please click here for more information.

WEDNESDAY, AUGUST 30

7:00 am Registration

7:25 Breakout Discussion Groups with Continental Breakfast

PREDICTIVE BIOMARKERS IN IMMUNO-ONCOLOGY

8:25 Chairperson's Remarks

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

8:30 Are Biomarkers Still Necessary for the Era of Immuno-Oncology?

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

The recent breakthroughs in cancer immunotherapy have reshaped our understanding of tumor biology, especially its microenvironment. Despite the new promises from the first wave of immune checkpoint blockage therapies, only a minority of cancer patients can truly benefit from its long-term anti-tumor effect. As the result of the speedy approval and broad biological impacts of immunotherapy, there is a significant knowledge gap for the real-world adaptation of these new treatments and reliable biomarkers to guide safe and effective use of this new class of therapy in addition to the SOC.

9:00 Predictive Biomarkers in Immuno-Oncology

Jean-Marie Bruey, Ph.D., Companion Diagnostics Group Leader, Genentech

9:30 Building a Better Biomarker for Immune Therapy: Lessons Learned from Colon Cancer

Robert Anders, M.D., Ph.D., Associate Professor, Pathology, Johns Hopkins University

Cancer samples are predictive biomarkers that have long been used to select a patient's therapy. Predictive biomarkers such as the expression of specific proteins or presence of DNA mutations in an oncogenic pathway have been used to select patients for targeted therapies. It is unlikely a single biomarker will be specific for selecting patients for immunotherapy. These concepts will be discussed in the setting of colorectal cancer.

10:00 Sponsored Presentation (Opportunity Available)

10:30 Coffee Break in the Exhibit Hall with Poster Viewing


11:15 KEYNOTE PRESENTATION: Strategy for Development of Predictive Biomarkers for Immunotherapy

Ignacio I. Wistuba, M.D., Department Chair, Department of Translational Molecular Pathology, Division of Pathology & Lab Medicine, The University of Texas MD Anderson Cancer Center

As new immunotherapy strategies are being developed, particularly inhibition of immune checkpoints, there is an urgent need to develop predictive biomarkers for these therapies. We are increasing our ability to characterize the immune, molecular and genomic events associated with response or resistance to these treatments in tumor tissue, blood and other specimens of patients treated with these novel therapies. This approach will help to identify mechanisms of resistance to immunotherapy.

11:45 Predictive and Prognostic IO Biomarkers and Their Utility in Clinical Trials

Jaclyn Neely, Ph.D., Senior Research Investigator II, Translational Medicine, IO Biomarker Lead, Bristol-Myers Squibb

The clinical benefit of immunotherapies is only demonstrated in a subset of patients. Single biomarkers are often not sufficient to predict response to immunotherapies. This presentation will review the importance of collecting predictive biomarker data, the associated challenges and opportunities, and how this data may inform the appropriate treatment of patients.

12:15 pm Multi-Omics Artificial Intelligence-Based Approaches for Identifying Immunotherapy Responders

Olivier Elemento, Ph.D., Cancer Systems Biology and Precision Medicine, Weill Cornell Medicine

In this talk I will present my group's work on the (CLIA) whole-exome sequencing-based genomic test for precision cancer medicine and immunotherapy. A novel analytical pipeline that analyzes genomic profiles to unravel the immune landscape of tumors and integrates multi-omics features using machine learning to predict immunotherapy response will be described. Finally, high-throughput single cell genomics approaches to dissect the tumor microenvironment and unravel immune repertoires at the single cell resolution will be presented.

12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Session Break

COMPLIMENTARY AND COMPANION DIAGNOSTICS: PD-L1 AND BEYOND

1:55 Chairperson's Remarks

Deepti Aurora-Garg, Ph.D., Director, Companion Diagnostics, Merck

2:00 Development of a Complimentary Diagnostic for Tecentriq

Zachary Boyd, Ph.D., Companion Diagnostic Program Leader - Tecentriq (Atezolizumab), Genentech

Tecentriq (Atezolizumab) is the first anti-PD-L1 cancer immunotherapy to approved for the treatment of advanced non-small cell lung cancer (NSCLC) and urothelial carcinoma (UC). To assess the association of PD-L1 expression with therapeutic benefit, we partnered with Ventana Medical Systems to develop an immunohistochemistry assay to detect PD-L1 expression on specific cell types within the tumor microenvironment. The Ventana SP142 PD-L1 IHC was co-labeled with Tecentriq as a complementary diagnostic in NSCLC and UC. In this talk, I will review the underlying biomarker hypotheses that informed development of the SP142 assay and ultimate approval as a complementary diagnostic.

2:30 Evaluation of Multiple Biomarkers in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) in Response to Keytuda®

Deepti Aurora-Garg, Ph.D., Director, Companion Diagnostics, Merck

HNSCC is generally associated with deficiencies of the immune system. Tumor-infiltrating lymphocytes activate interferon-mediated signaling that in turn induces expression of immune suppressive molecules (eg, PD-L1, PD-L2, IDO1) on cells in the tumor environment. Upregulation of immune suppressive molecules enables tumors to evade immune surveillance and progress. Keytruda, an anti-PD-1 antibody, blocks the interaction between PD-1 and its ligands. Hence in the Keytruda trials PD-L1, PD-L2 and gene expression signatures were evaluated to understand their utility in predicting response to Keytruda.

3:00 Biomarkers and Companion Diagnostics in Oncology Drug Development: Is It Paying Off?

Abdel Halim, Ph.D., Vice President, Translational Medicine, Biomarkers & Diagnostics, Celldex Therapeutics

3:30 Refreshment Break in the Exhibit Hall with Poster Viewing

BIOMARKERS OF RESPONSE AND RESISTANCE TO IMMUNOTHERAPY

4:15 Molecular Biomarkers of Response to Keytruda

Andrey Loboda, Ph.D., Director, Genetics and Pharmacogenomics, Merck

The talk will address molecular biomarkers of response to Pembrolizumab, including the role of tumor antigenicity, as measured by mutational load (ML) and T-cell inflamed microenvironment in predicting the response to Pembrolizumab. Data will be presented that prospectively validates the utility of both biomarkers as tumor type agnostic and orthogonal measures of response. These findings provide a biomarker framework for development of Pembrolizumab as a monotherapy and for characterizing responses to novel immunotherapy regimens.

4:45 Pathologic Response Patterns in Neoadjuvant Trials with Immunotherapy

Janis Taube, M.D., Associate Professor, Dermatology & Pathology, Johns Hopkins University

Neoadjuvant therapeutic response is graded by surgical pathology upon receipt of the resection specimen. Histopathologic features of response to immunotherapy in the neoadjuvant setting differ from features seen in response to neoadjuvant chemotherapy and targeted therapies. Those histopathologic features will be highlighted in the context of early clinical trials of immunotherapeutics in the neoadjuvant setting. These specimens also provide opportunity to study mechanisms of response and resistance to immunotherapy.

5:15 Understanding the Heterogeneity and Dynamics of Responses to Checkpoint Blockade in Melanoma

Alexandre Reuben, Ph.D., Postdoctoral Fellow, Surgical Oncology, The University of Texas MD Anderson Cancer Center

The success of immune checkpoint blockade has led to major efforts to identify biomarkers and mechanisms of response and resistance, specifically in melanoma. Here, we performed molecular (whole exome sequencing, gene expression profiling) and immune (immunohistochemistry, T cell receptor sequencing) profiling of longitudinal samples from patients treated with sequential CTLA-4 and PD-1 blockade. These studies shed light on biomarkers of response and mechanisms of resistance to immune checkpoint blockade.

5:30 Biomarkers of Response/Progression in RCC Patients Receiving PD-1/PD-L1 Inhibitors

Aly-Khan Lalani, M.D., Genitourinary Oncology Fellow, Dana-Farber Cancer Center

We review in situ biomarkers (PD-1/PD-L1) and the challenges associated with wider implementation, including localization and tumor heterogeneity. What role can genomic and immune signatures play to help? We also touch on the importance of pharmacodynamic changes on therapy and upon resistance. Finally, we summarize ongoing and future efforts, particularly with plasma and non-invasive biomarkers.

5:45 Close of Biomarkers for Immuno-Oncology




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