CONTENTS. Sponsors. Introduction Letter. Program Agenda. Faculty Listing. Notes

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2 CONTENTS Sponsors Introduction Letter Program Agenda Faculty Listing Notes

3 SPONSORED BY: Advances in Minimal Residual Disease Testing in Myeloma: New York 2

4 Ola Landgren, MD, PhD Chief, Myeloma Service Memorial Sloan Kettering Cancer Center Professor of Medicine at the Weill Cornell Medical College Dear Colleagues, On behalf of the Organizing Committee for Advances in Minimal Residual Disease Testing in Multiple Myeloma: New York Meeting, we would like to thank you for your time and collaboration in joining us for this remarkable event for multiple myeloma patients. With recent scientific and technological advances, we know more than ever before about multiple myeloma and are now in a position to develop a common framework for accelerating the clinical development of much needed and promising minimal residual disease (MRD) testing in multiple myeloma. In reviewing emerging scientific data on MRD testing in multiple myeloma, it becomes clear that the field is moving fast forward. Using newer, modern drugs the vast majority of patients obtain deep clinical responses. Among patients who reach a complete response (CR), several studies consistently show that MRD negativity is associated with better progressionfree and overall survival. There is no doubt that MRD testing is important in multiple myeloma. During this workshop, participants will discuss and develop cutting edge strategies related to MRD testing in multiple myeloma, in the setting of standard of care, in clinical trials, and from a regulatory perspective. This is a seminal meeting focused on progress and actions to leverage the leading edge of science on behalf of patients, and patients will certainly be taking notice. Thank you again for your active participation in making this a very productive workshop to advance MRD testing in multiple myeloma! Welcome to New York City! Ola Landgren, MD, PhD Chief, Myeloma Service Memorial Sloan Kettering Cancer Center Professor of Medicine at the Weill Cornell Medical College Peter Brodhead Chief, CME Office Office of Physician-in-Chief Memorial Sloan Kettering Cancer Center Advances in Minimal Residual Disease Testing in Myeloma: New York 3

5 AGENDA Meeting Registration Welcome and Introduction: Overview of Advances in Myeloma MRD Testing in the Past 12 Months Ola Landgren, MD, PhD Regulatory Session Moderators: Faith Davies, MD; Noopur Raje, MD MRD as an endpoint in clinical trial for hematologic malignancies: approaches to drug approval in 2015 Nicole Gormley, MD Development of uniform MRD criteria in myeloma: next steps Sergio Giralt, MD MRD negativity is more important than given therapy to obtain MRD negativity: implications for drug development Roger Owen, MD MRD as a regulatory endpoint in multiple myeloma: on the path to drug approval Nicole Gormley, MD Group Discussion Regulatory Session Coffee Break Debate Session Moderators: Guenther Koehne, MD, PhD; Richard Little, MD Should MRD be an endpoint for all clinical trials for myeloma? YES: Nikhil Munshi, MD NO: Sundar Jagannath, MD Is MRD ready for prime time in standard clinical care? YES: Faith Davies, MD NO: Phil McCarthy, MD Is MRD ready as a regulatory endpoint in myeloma? YES: Roger Owen, MD NO: Suzanne Lentzsch, MD, PhD 7:00am 8:00am 8:00am 8:15am 8:15am 9:15am 9:15am 9:45am 9:45am 10:15am 10:15am 12:00pm Advances in Minimal Residual Disease Testing in Myeloma: New York 4

6 AGENDA Lunch Break My Dream Myeloma Study Design for a Clinical Trial Using MRD as a Primary Endpoint Moderator: Kim Jessup, MD Mohamed Hussein, MD; Karim Iskander, PhD; Tahamtan Ahmadi, MD, PhD Science Session: MRD Assays Moderators: Ola Landgren, MD, PhD; Gareth Morgan, MD Molecular and cell-based MRD testing: opportunities and challenges Malek Faham, MD, PhD Third generation flow cytometry based MRD testing Mikhail Roshal, MD, PhD Implementation of MRD testing in a multicenter myeloma trial Paul Wallace, PhD Group Discussion MRD Assays Coffee Break Science Session: Treatment and MRD Testing Moderators: Herve Avet-Loiseau, MD; Saad Usmani, MD Early diagnosis, optimal treatment: better overall survival in myeloma Sigurdur Kristinsson, MD, PhD Importance of deep clinical response for optimal outcome in myeloma Antonio Palumbo, MD Image-guided biopsies to capture residual disease and perform molecular characterization of MRD Jens Hillengass, MD Group Discussion Treatment and MRD Testing Thank You! Adjourn of Meeting 12:00pm 1:00pm 1:00pm 1:30pm 1:30pm 2:15pm 2:15pm 2:30pm 2:30pm 3:00pm 3:00pm 3:45pm 3:45pm 4:00pm 4:00pm A live web-cast summarizing the meeting will take place from 4:30 5:00pm. Meeting participants are welcome to stay as audience. Advances in Minimal Residual Disease Testing in Myeloma: New York 5

7 FACULTY Tahamtan Ahmadi, MD, PhD Janssen Pharmaceuticals Herve Avet-Loiseau, MD University Hospital Faith Davies, MD University of Arkansas for Medical Sciences fedavies@uams.edu ext.8138 Malek Faham, MD, PhD Adaptive Biotechnologies mfaham@adaptivebiotech.com Sergio Giralt, MD Janssen Pharmaceuticals giralts@mskcc.org Nicole Gormley, MD Food and Drug Administration Nicole.Gormley@fda.hhs.gov Jens Hillengass, MD University of Heidelberg Jens.Hillengass@med.uni-heidelberg.de Mohamad Hussein, MD Celgene mhussein@celgene.com Karim Iskander, PhD Onyx / Amgen kiskander@onyx.com Sundar Jagannath, MD Mount Sinai Medical Center Mt. Sinai School of Medicine sundar.jagannath@mountsinai.org Kim Jessup, MD National Cancer Institute jessupj@mail.nih.gov Guenther Koehne, MD, PhD Memorial Sloan Kettering Cancer Center koehneg@mskcc.org Sigurdur Kristinsson, MD, PhD University of Iceland sigyngvi@hi.is Ola Landgren, MD, PhD Memorial Sloan Kettering Cancer Center landgrec@mskcc.org Suzanne Lentzsch, MD, PhD Columbia University Medical Center sl3440@columbia.edu Advances in Minimal Residual Disease Testing in Myeloma: New York 6

8 FACULTY Richard Little, MD National Cancer Institute Phil McCarthy, MD Roswell Park Cancer Institute Gareth Morgan, MD, PhD, FRCP, FRCPath University of Arkansas for Medical Sciences CURE (2873) Nikhil Munshi, MD Dana-Farber Cancer Institute Harvard Medical School Roger Owen, MD St James s Institute of Oncology rogerowen@nhs.net Antonio Palumbo, MD University of Torino appalumbo@yahoo.com e+011 Noopur Raje, MD Massachusetts General Hospital nraje@partners.org Mikhail Roshal, MD, PhD Memorial Sloan-Kettering Cancer Center mroshal@gmail.com Saad Usmani, MD Carolinas HealthCare System Levine Cancer Center Saad.Usmani@carolinashealthcare.org Paul Wallace, PhD Roswell Park Cancer Institute Paul.Wallace@RoswellPark.org Advances in Minimal Residual Disease Testing in Myeloma: New York 7

9 NOTES Advances in Minimal Residual Disease Testing in Myeloma: New York 8

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15 NOTES Advances in Minimal Residual Disease Testing in Myeloma: New York 14

16 Multiple Myeloma Research Foundation 383 Main Avenue, 5th Floor Norwalk, CT