CONTENTS

Sponsors

Introduction Letter

Program Agenda

Faculty Listing

Notes

2

3

4

6

8

Advances in Minimal Residual Disease Testing in Myeloma: New York | 2

SPONSORED BY:

Advances in Minimal Residual Disease Testing in Myeloma: New York | 3

Ola Landgren, MD, PhDChief, 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 progression-free 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 | 4

AGENDA

Meeting Registration 7:00am – 8:00am

Welcome and Introduction: Overview of Advances in Myeloma MRD Testing in the Past 12 MonthsOla Landgren, MD, PhD

8:00am – 8:15am

Regulatory SessionModerators: 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

8:15am – 9:15am

Group Discussion Regulatory Session 9:15am – 9:45am

Coffee Break 9:45am – 10:15am

Debate SessionModerators: 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

10:15am – 12:00pm

Advances in Minimal Residual Disease Testing in Myeloma: New York | 5

Lunch Break 12:00pm – 1:00pm

My “Dream” Myeloma Study Design for a Clinical Trial Using MRD as a Primary EndpointModerator: Kim Jessup, MD

■ Mohamed Hussein, MD; Karim Iskander, PhD; Tahamtan Ahmadi, MD, PhD

1:00pm – 1:30pm

Science Session: MRD AssaysModerators: 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

1:30pm – 2:15pm

Group Discussion MRD Assays 2:15pm – 2:30pm

Coffee Break 2:30pm – 3:00pm

Science Session: Treatment and MRD TestingModerators: Herve Avet-Loiseau, MD; Saad Usmani, MD

■ Early diagnosis, optimal treatment: better overall survival in myeloma SigurdurKristinsson,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

3:00pm – 3:45pm

Group Discussion Treatment and MRD Testing 3:45pm – 4:00pm

Thank You! Adjourn of Meeting 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.

AGENDA

Advances in Minimal Residual Disease Testing in Myeloma: New York | 6

FACULTY

Tahamtan Ahmadi, MD, PhD Janssen Pharmaceuticals tahmadi@its.jnj.com 267.648.3297

Herve Avet-Loiseau, MD University Hospital avet-loiseau.h@chu-toulouse.fr +33 5 31 15 61 42

Faith Davies, MD University of Arkansas for Medical Sciences fedavies@uams.edu 501.526.6990 ext.8138

Malek Faham, MD, PhD Adaptive Biotechnologies mfaham@adaptivebiotech.com 650.243.3900

Sergio Giralt, MD Janssen Pharmaceuticals giralts@mskcc.org 212.639.3859

Nicole Gormley, MD Food and Drug Administration Nicole.Gormley@fda.hhs.gov 240.402.0210

Jens Hillengass, MD University of Heidelberg Jens.Hillengass@med.uni-heidelberg.de +49 6221 56

Mohamad Hussein, MD Celgene mhussein@celgene.com 908.673.9731

Karim Iskander, PhD Onyx / Amgen kiskander@onyx.com 650.266.1052

Sundar Jagannath, MD Mount Sinai Medical Center Mt. Sinai School of Medicine sundar.jagannath@mountsinai.org 212.241.7873

Kim Jessup, MD National Cancer Institute jessupj@mail.nih.gov 240.276.5952

Guenther Koehne, MD, PhD Memorial Sloan Kettering Cancer Center koehneg@mskcc.org 212.639.8599

Sigurdur Kristinsson, MD, PhD University of Iceland sigyngvi@hi.is +354 525 4000

Ola Landgren, MD, PhD Memorial Sloan Kettering Cancer Center landgrec@mskcc.org 212.639.5126

Suzanne Lentzsch, MD, PhD Columbia University Medical Center sl3440@columbia.edu 646.317.4840

Advances in Minimal Residual Disease Testing in Myeloma: New York | 7

Richard Little, MD National Cancer Institute littler@mail.nih.gov 240.276.6093

Phil McCarthy, MD Roswell Park Cancer Institute Philip.McCarthy@RoswellPark.org 716.845.4074

Gareth Morgan, MD, PhD, FRCP, FRCPath University of Arkansas for Medical Sciences GJMorgan@uams.edu 501.526.CURE (2873)

Nikhil Munshi, MD Dana-Farber Cancer Institute Harvard Medical School Nikhil_Munshi@dfci.harvard.edu 617.632.4218

Roger Owen, MD St James’s Institute of Oncology rogerowen@nhs.net +44 113 206 7851

Antonio Palumbo, MD University of Torino appalumbo@yahoo.com 3.9334901724e+011

Noopur Raje, MD Massachusetts General Hospital nraje@partners.org 617.726.8033

Mikhail Roshal, MD, PhD Memorial Sloan-Kettering Cancer Center mroshal@gmail.com 212.746.2096

Saad Usmani, MD Carolinas HealthCare System Levine Cancer Center Saad.Usmani@carolinashealthcare.org 980.442.5236

Paul Wallace, PhD Roswell Park Cancer Institute Paul.Wallace@RoswellPark.org 716.845.8471

FACULTY

Advances in Minimal Residual Disease Testing in Myeloma: New York | 8

NOTES

Advances in Minimal Residual Disease Testing in Myeloma: New York | 9

NOTES

Advances in Minimal Residual Disease Testing in Myeloma: New York | 10

NOTES

Advances in Minimal Residual Disease Testing in Myeloma: New York | 11

NOTES

Advances in Minimal Residual Disease Testing in Myeloma: New York | 12

NOTES

Advances in Minimal Residual Disease Testing in Myeloma: New York | 13

NOTES

Advances in Minimal Residual Disease Testing in Myeloma: New York | 14

NOTES

Multiple Myeloma Research Foundation383 Main Avenue, 5th Floor

Norwalk, CT 06851203.229.0464

www.themmrf.org