( がん免疫療法に対応するバイオマーカーとコンパニオン診断 )

Recent advances in cancer immunotherapy have generated excitement across all fields of oncology. However, the field is still experiencing a lack of predictive biomarkers and patient selection remains difficult. Challenges in discovering predictive biomarkers for cancer immunotherapy involve multiple cell types, multiple mechanisms of T-cell regulation, genetic heterogeneity of tumors, immune components, etc. Cambridge Healthtech Institute’s 2nd Annual Immuno-Oncology Biomarkers & Companion Dx program is designed to bring together clinical immuno-oncologists, researchers from pharmaceutical companies and laboratory medicine leaders to discuss the underlying mechanisms of cancer immunotherapy, its predictive biomarkers as well as existing and emerging clinical assays aiming to improve patient outcomes.

Final Agenda

Arrive Early for:

SUNDAY, MARCH 10, 2:00 - 5:00 PM (AFTERNOON SHORT COURSES)

SC7: Omic Technology for Cancer Immunology

SUNDAY, MARCH 10, 5:30 - 8:30 PM (DINNER SHORT COURSES)

SC14: Liquid Biopsy Technologies and Applications

MONDAY, MARCH 11, 8:00 - 11:00 AM (MORNING SHORT COURSES)

SC22: Cellular Phenotyping Assays in Oncology Trials

Monday, March 11

10:30 am Conference Program Registration Open

INFORMING COMBINATIONS

11:50 Chairperson’s Opening Remarks

Paul Robbins, PhD, Senior Director, Immuno-Oncology, Early Development & Translational Oncology, Pfizer, Inc.

12:00 pm KEYNOTE PRESENTATION: Biomarkers to Inform Trial Design and Combinations in Immuno-Oncology

Mazumder_RonRon Mazumder, PhD, MBA, Vice President, Oncology Biomarker Development & Companion Diagnostics, Genentech

I will discuss PD/MOA, predictive and surrogate biomarkers and their use in drug development.

 


12:30 KEYNOTE PRESENTATION: The Targeted Agent and Profiling Utilization Registry Study: Rationale, Design and Preliminary Findings

Richard SchilskyRichard L. Schilsky, MD, FACP, FSCT, FASCO, Senior Vice President, CMO, American Society of Clinical Oncology

The TAPUR Study, a Phase II, prospective, non-randomized, multi-basket, pragmatic clinical trial aims to identify signals of drug activity when FDA approved drugs are matched to pre-specified genomic targets in patients with advanced cancer. More than 1100 participants have thus far received one of 15 possible treatments. Four study cohorts have closed due to lack of anti-tumor activity and 16 have expanded to the second stage due to promising preliminary results.

1:00 Session Break

Visiopharm_NEW 1:10 Luncheon Presentation I: Multiplex Image Analysis in The Tumor Microenvironment Using Artificial Intelligence

Ben Freiberg, Visiopharm

The phenotypes of cells within the tumor microenvironment has been shown to correlate with disease progression and outcome in cancer patients.  Artificial Intelligence, including machine learning and deep learning, provides tools to accurately define these phenotypes to better understand cancer.

Medgenome 1:40 Luncheon Presentation II: Presentation to be Announced

2:10 Session Break

2:30 Chairperson’s Remarks

Paul Robbins, PhD, Senior Director, Immuno-Oncology, Early Development & Translational Oncology, Pfizer, Inc.

2:40 The Evolution of Precision Medicine for Immuno-Oncology: How Patient Selection and Combination Therapy Are Changing the Paradigm

Zhen SuZhen Su, MD, MBA, Senior Vice President & CMO, NA, EMD Serono, Inc.

The immuno-oncology treatment landscape has rapidly evolved over the past several years. We have seen unprecedented responses in subsets of patients that have provided hope to the future of medical oncology. However, non-responsive patient subsets remain a clinical challenge. Will combination therapy and patient selection result in increased patient response rates? And how can we best develop precision medicine approaches to ensure successful responses in real world settings?

3:10 Biomarkers in the Context of I/O Combinations

Robbins_PaulPaul Robbins, PhD, Senior Director, Immuno-Oncology, Early Development & Translational Oncology, Pfizer, Inc.

I/O and non-I/O combinations are achieving unprecedented clinical successes and represent our best opportunity to expand the patient subsets who derive clinically meaningful benefit from treatment. Optimal use of I/O combinations requires detailed knowledge of the mechanisms and interdependencies of tumor biology and immunology underlying the disease and response to therapy. A key question is whether I/O biomarkers in use/development for monotherapy are appropriate for use with I/O and non-I/O combinations.

3:40 PANEL DICUSSION: Enhancing the Impact of Biomarkers in Clinical Trials with I/O Combinations

Moderator: Paul Robbins, PhD, Senior Director, Immuno-Oncology, Early Development & Translational Oncology, Pfizer, Inc.

Panelists: Speakers of the Day

  • Current and emerging biomarkers for patient selection for immuno-oncology therapies – will current assays be combined or completely superseded? Are standard clinical biomarkers being overlooked in I/O trials?
  • Beyond the biopsy - what is the current utility and future potential of blood-based biomarkers?
  • NGS panels have arrived – are we ready to analyze and interpret the data from complex transcript panels? How can biomarker data be used to improve target discovery and/or combo prioritization?
  • Harmonization of multiple assays for the similar biomarker(s) – should this be achieved during development and whose responsibility is it?

GuardantHealth 4:10 Presentation to be Announced

4:40 Refreshment Break and Transition to Plenary Session


5:00 Plenary Keynote Session

6:00 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:30 Close of Day

Tuesday, March 12

7:30 am Registration Open and Morning Coffee


8:00 Plenary Keynote Session

9:15 Refreshment Break in the Exhibit Hall with Poster Viewing

GENOMIC DETERMINANTS OF RESPONSE

10:15 Chairperson’s Remarks

Roopa Srinivasan, PhD, Senior Director, Head, Translational Research, Immuno-Oncology & Combinations, GSK

10:25 Genomic Determinants of Response to Pembrolizumab: Impact on Combination Strategies for Cancer Immunotherapy

Terri McClanahanTerri McClanahan, PhD, Executive Director, Molecular Discovery, Translational Medicine, Merck

Pan-cancer molecular biomarkers of immunotherapy response can identify patients likely to derive benefit from PD-1/PD-L1-directed monotherapy, while also proving useful for guiding the rational use of combination immunotherapy regimens. Data will be presented showing that somatic mutational load (ML) and a T-cell inflamed gene expression profile (GEP) are key determinants and independent predictors of response to pembrolizumab across multiple tumor types, and provide a framework for novel approaches to cancer therapy.

10:55 Biomarker Hypotheses Derivations to Drive Translational Research for IO Agents - Strengths and Challenges

Roopa Srinivasan, PhD, Senior Director, Head, Translational Research, Immuno-Oncology & Combinations, GSK

Biomarkers are critical in projecting pharmacodynamic activity and efficacy signals of various immuno-oncology drugs. The process of evaluation is continuous from bench to bedside and back to ensure that hypotheses projected are valid in clinical trials. Multiple approaches both non-clinical and clinical are necessary to define optimum biomarkers and functions they measure, some of which will be discussed.

11:25 Opportunities and Challenges of Liquid Biopsy IVDs for Cancer Immunotherapy

Destenaves_BenoitBenoit Destenaves, PharmD, Director, Diagnostics Lead, Precision Medicine and Genomics, Innovative Medicines and Early Development (IMED) biotech unit, AstraZeneca

Next Generation Sequencing and Liquid biopsies offer exciting novel opportunities to bring innovative drugs to patients. But these opportunities do not come without challenges and will need to be resolved particularly when looking at genomic signatures such as Tumor Mutational Burden (TMB).

TransHitBiomarkers 11:55 How Biospecimen Sourcing Can Impact Your R&D Results

Vanessa Tumilasci, PhD, Commercial Director, Trans-Hit Bio

Biospecimen sourcing is becoming a challenge for many scientists who need to respect timelines for R&D plans as well as regulatory and ethical constraints. Are the scientists working with the samples aware of all the imperatives to obtain them: quality, respect of laws, ethics and regulations?

12:10 pm Advanced Multiplexing Reagents for Measuring Biomarker Expression and Cell Behavior in Tissue

Sean Downing, PhD, Director, Customer Engagement, Ultivue

The benefits of multiplex immunohistochemistry assays for tissue analysis are numerous. High-level multiplexing, whole slide imaging, workflow compatibility, and spatial analysis are all must-have requirements for effective multiplex IHC solutions. Ultivue’s InSituPlex® technology addresses each of these needs and enables researchers to unmask the true biology of tissue samples

12:25 Session Break

MolecularMD 12:35 Luncheon Presentation I :Co-development
 of a Drug and a Diagnostic…Controlling the Diagnostic Channel

Dan Snyder, President & CEO, MolecularMD

Discovery-Life-Sciences 1:05 Luncheon Presentation II: Large-Scale Cohort Development Supporting Companion Dx and IO
Biomarker Discovery.

Shawn Fahl, Senior Research Scientist, Discovery Life Sciences

This session will provide case studies in custom cohorts designed to expedite biomarker research through the integration of high-quality biosamples with clinical data, phenotypic, and genotypic characterizations. For example, a 200 patient NSCLC cohort including tissue microarray blocks, PD-L1 stains/imaging, and oncogene sequencing data for rapid biomarker analysis.

1:35 Refreshment Break in the Exhibit Hall with Poster Viewing

COMPANION DIAGNOSTICS IN IMMUNO-ONCOLOGY

2:05 Chairperson’s Remarks

Kenneth Emancipator, MD, Executive Medical Director and Head of Companion Diagnostics, Merck & Co., Inc.

2:10 Companion Diagnostics in Immuno-Oncology

Donna Roscoe, PhD, Chief, Molecular Genetics Branch, Division of Molecular Genetics and Pathology Devices, Office of In Vitro Diagnostics and Radiological Health, FDA CDRH

This session will focus on the implementation of immuno-oncology diagnostic tests in clinical trials, including understanding the regulatory implications of different approaches, validation of emerging pan-tumor CDx claims, and complementary diagnostics vs. companion diagnostics.

2:40 PD-L1 as a Companion Diagnostic for Tumors beyond Non-Small Cell Lung Cancer: It’s the Same Thing, Only Different

Emancipator_KennethKenneth Emancipator, MD, Executive Medical Director and Head of Companion Diagnostics, Merck & Co., Inc.

The PD-L1 companion diagnostic had a huge impact on the clinical development of pembrolizumab, making it the first immunotherapy approved as a first-line agent for non-small cell lung cancer. However, this is just the beginning of the story, not the end. Adapting the PD-L1 diagnostic to incorporate immune cell expression facilitated approval of pembrolizumab for several additional indications and may shed light on the mechanism of action of checkpoint inhibitors.

3:10 Companion Diagnostics for the Adjuvant Setting for Immune Therapy

Rimm_DavidDavid L. Rimm, MD, PhD, Professor of Pathology and of Medicine (Medical Oncology); Director of Pathology Tissue Services; Director of Translational Pathology, Yale University School of Medicine

Companion diagnostics for immune checkpoint blockade (ICB) therapy have all been designed and executed by the pharma companies producing the drugs. However, in the adjuvant setting, better markers are needed, but unlikely to come from pharma where the companion test is either already established or not required. In the adjuvant setting, since the side effects are toxic and only 1 in 5 benefits, biomarkers that predict which patients do NOT need drug are most important. Most likely these biomarkers will be produced by biotech, since they need to exclude rather than include the ICB drugs. Here we will discuss biomarkers with promise for selection in the adjuvant setting for ICB therapy. They will include both gene expression profiles and multiplex quantitative fluorescent tests with predictive potential.

NeoGenomics3:40 Presentation to be Announced

 

4:10 St. Patrick’s Day Celebration in the Exhibit Hall with Poster Viewing

5:00 Breakout Discussions in the Exhibit Hall

Precision Medicine in IO

Zhen Su, MD, Senior Vice President & CMO, EMD Serono

Theresa LaVallee, PhD, Vice President, Translational Medicine and Regulatory Affairs, Parker Institute for Cancer Immunotherapy

George Green, PhD, Head, Pharmacodiagnostics, Bristol-Myers Squibb

  • How can we better identify clinically relevant combination therapies upfront?
  • Are there ways to improve patient selection for IO therapy?
  • What are common challenges with IO therapy in the real-world setting?

Emerging Technologies for IO Biomarkers

Majid Ghoddusi, DVM, PhD, Head, Pathology, Translational Science, Juno Therapeutics, A Celgene Company

Benoit Destenaves, PharmD, Director, Precision Medicine Lead, Precision Medicine and Genomics, Innovative Medicines and Early Development, AstraZeneca

Parallel Analysis of Circulating Biomarkers in Immunotherapy

Genevieve Boland, MD, PhD, Director, Melanoma Surgery Program, Massachusetts General Hospital; Director, Surgical Oncology Research Laboratories, Massachusetts General Hospital; Assistant Professor, Harvard Medical School; Associate Member, Broad Institute

  • Clinical application of blood-based biomarkers in melanoma
  • Unmet clinical needs in blood-based biomarkers
  • Microvesicle applications in immunotherapy

6:00 Close of Day

Wednesday, March 13

7:30 am Registration Open and Morning Coffee


8:00 Plenary Keynote Session

10:00 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall

PATIENT SELECTION APPROACHES

10:50 Chairperson’s Remarks

Theresa LaVallee, PhD, Vice President, Translational Medicine and Regulatory Affairs, Parker Institute for Cancer Immunotherapy

11:00 Immuno-Oncology Biomarkers:  What’s New?

Green_GeorgeGeorge Green, PhD, Head, Pharmacodiagnostics, Bristol-Myers Squibb

Precision medicine continues to transform treatment paradigms through development of new biomarkers and interpretation of clinical data. Testing for Immuno-Oncology biomarkers, such as PD-L1, and emerging ones, such as tumor mutational burden, may help optimize treatment decisions when assessed individually or in combination. The advancement of increasingly complex biomarkers also brings a need for advanced diagnostic tools.  We will discuss biomarkers, their dynamic monitoring, and assessment in the evolving field of pharmacodiagnostics.

11:30 The Parker Institute’s Collaborative and Integrated Approach to Immuno-Oncology: Innovative Clinical Trials and Biomarkers

LaVallee_TheresaTheresa LaVallee, PhD, Vice President, Translational Medicine and Regulatory Affairs, Parker Institute for Cancer Immunotherapy

The Parker Institute for Cancer Immunotherapy’s mission is to accelerate the development of breakthrough immune therapies to turn cancer into a curable disease. Through collaborative efforts utilizing innovative technologies and integrating clinical and correlative datasets, Parker is advancing the understanding and utilization of immuno-oncology biomarkers.

12:00 pm In silico Analysis of Concomitant Medications in Atezolizumab Trials

Nagarkar_DeeptiDeepti Nagarkar, PhD, Scientific Manager, Cancer Immunology, Research, Genentech

Concomitant medications (ConMeds) are relevant clinical covariates that may influence response to cancer immunotherapy (CIT). Pharmacological action based drug baskets were generated to explore immune modulation in cancer subjects receiving Atezolizumab. We observed changes in inflammatory response genes in diabetic patients receiving single or combination treatments at the start of the trial. This suggests that curation of ConMeds may help stratify immune set point of patients receiving CIT.

12:30 Session Break

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

1:10 Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing

T-CELL THERAPY AND COMBINATIONS: BIOMARKER CONSIDERATIONS

1:50 Chairperson’s Remarks

Iulian Pruteanu-Malinici, Investigator III, Lab Head, Immuno-Oncology, Novartis

2:00 Predicting Cellular Therapies Success Failure with Biomarkers: Where Do We Stand?

Majid GhoddusiMajid Ghoddusi, DVM, PhD, Majid Ghoddusi, Senior Director, Clinical Biomarkers, Poseida Therapeutics

Robust and durable responses have been the main drive for the excitement that promises cellular therapies to be yet another powerful tool in fight against cancer. There is now enough evidence at our disposal to know that these therapies do not work in all patients, and when they work the benefits may not last very long. We are at the beginning of the road to understand what characteristics are likely to predict which patient might benefit from a given cellular therapy. Data have also started to emerge that might shed light on why some patients fail to respond in a durable fashion.

Adaptive-Biotechnologies2:25 Talk Title to be Announced

Catherine Sanders, Senior Director, Research and Business Development, Adaptive Biotechnologies Corp.

 

2:40 T-Cell Receptor Expansion in Peripheral Blood as a Pharmacodynamic Biomarker for Immunomodulatory Agents

Davis_CraigCraig Davis, PhD, Senior Director, Immuno-Oncology, Early Development & Translational Oncology, Pfizer, Inc.

Changes in T-cell frequency can be tracked via quantitation of TCRB rearrangements using ImmunoSEQTM. A new method for measuring differential abundance of TCR clones in peripheral blood introduces a variance (dispersion) parameter to model typical biological variability based on the beta-binomial distribution. Application of the beta-binomial to data derived from peripheral blood from normal donors and cancer patients enables robust identification of TCRs that change abundance following intervention.

3:05 Clinical Predictors of T Cell Fitness for CAR T Cell Manufacturing and Efficacy in Multiple Myeloma Using RShiny, FlowType, Citrus and Spade

Pruteanu_IulianIulian Pruteanu-Malinici, Investigator III, Lab Head, Immuno-Oncology, Novartis

The optimal clinical setting for CAR T cell therapy in multiple myeloma (MM) remains uncertain. In CLL patients treated with anti-CD19 CAR T cells (CART19), frequency of an early memory (early-mem) T cell phenotype (CD27+ CD45RO- CD8+) at time of leukapheresis was predictive of clinical response independently of other patient- or disease-specific parameters and was associated with enhanced capacity for in vitro T cell expansion and CD19-responsive activation (Fraietta et al. Nat Med 2018); T cell fitness is therefore a major determinant of response to CAR T cell therapy. Here, we report that higher frequency of early-mem T cells and CD4/CD8 ratio in the leukapheresis product are associated with favorable clinical response to anti-BCMA CAR T cells (CART-BCMA) in relapsed/refractory MM patients.

3:30 Session Break

PREDICTIVE BIOMARKER ASSAY DEVELOPMENT

3:40 Chairperson’s Remarks

Kurt SchalperKurt A. Schalper, MD, PhD, Assistant Professor, Pathology and Medicine (Medical Oncology); Director, Translational Immuno-Oncology Laboratory, Yale Cancer Center


3:45 Validation of Multiplex Immunofluorescence Panels for Characterization of the Tumor Microenvironment

Pandya_DimpleDimple Pandya, MD, Principle Scientist, Bristol-Myers Squibb

Advances in immunotherapy have ushered a new era in cancer care and with it a need to identify predictive and prognostic biomarkers. Multiplex immunofluorescence (mIF) is a valuable tool for characterization and understanding of the interaction between the tumor and the immune system. Critical to transitioning this technology from bench to bedside is standardizing the validation process and an integrated digital and pathology workflow system. This talk will outline our experience on validating and designing a workflow process for analyzing multiplex immunofluorescent panels for immune profiling.

4:15 Development and Validation Considerations for Clinical Laboratory Methods for Mutational Burden Determination

Konnick_EricEric Konnick, MD, MS, Assistant Professor; Associate Director, Genetics and Solid

Tumors Laboratory, University of Washington

Recent studies have indicated that increased mutational burden and microsatellite instability may predict response to anti-cancer therapies targeting the immune system. Many pre-analytical, analytical, and design factors may contribute to the ability of a clinical diagnostic test to appropriately measure the biomarker of interest. A thorough understanding of the relevant factors that can impact patient results will allow an appropriate comparison of existing methods and implementation of new assays.

4:45 Deconvoluting Cellular Determinants of Anti-Tumor Immune Recognition

Ash AlizadehAsh Alizadeh, PhD, Associate Professor of Medicine, Divisions of Oncology & Hematology, Stanford University School of Medicine

I will discuss our work on developing techniques to characterize the cellular organization of tumor microenvironments, with a focus on compositional diversity and clinical significance of hematopoietic cell subsets. I will describe the genesis and application of deconvolution algorithms to resolve tumor subpopulations and cell type-specific expression programs from genomic profiles of diverse human tumors. I will discuss the clinical translational potential in the context of individualized approaches to immuno-oncology.

5:15 Close of Conference Program


Stay Late for:

MARCH 14-15

S5: Circulating Cell-Free DNA
S8: Adoptive Cell-Based Cancer Immunotherapy
S9: Neoantigen-Based Immunotherapies

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

Choose your language
Traditional Chinese
Simplified Chinese
Korean
English


更新履歴
2019/02/25
スポンサー更新
2019/02/13
イベント情報更新
2019/02/01
アジェンダ・スポンサー更新
2019/01/09
スポンサー更新




メール配信サービス