ASH 2023: MRD Highlights in BioPharma Drug Development

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Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial.

Lin Yi, et al.
Nature Medicine
August 2023
Authors and Affiliates
Yi Lin  1 , Noopur S. Raje2, Jesús G. Berdeja  3, David S. Siegel  4, Sundar Jagannath  5, Deepu Madduri5, Michaela Liedtke6, Jacalyn Rosenblatt7, Marcela V. Maus  2, Monica Massaro8, Fabio Petrocca8, Ashish Yeri8, Olivia Finney8, Andrea Caia9, Zhihong Yang9, Nathan Martin9, Timothy B. Campbell9, Julie Rytlewski9, Jaymes Fuller9, Kristen Hege9, Nikhil C. Munshi  10 & James N. Kochenderfer  11 1Mayo Clinic, Rochester, MN, USA. 2Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA. 3Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN, USA. 4Hackensack University Medical Center, Hackensack, NJ, USA. 5Mount Sinai Medical Center, New York City, NY, USA. 6Stanford University Medical Center, Palo Alto, CA, USA. 7Beth Israel Deaconess Medical Center, Boston, MA, USA. 8 2SeventyBio, Inc, Cambridge, MA, USA. 9Bristol Myers Squibb, Princeton, NJ, USA. 10Dana-Farber Cancer Institute, Boston, MA, USA. 11Surgery Branch, National Cancer Institute/National Institutes of Health, Bethesda, MD, USA."

Measurable residual disease in Japanese patients with relapsed or refractory chronic lymphocytic leukemia treated with venetoclax.

Izutsu K, et al.
International Journal of Hematology
August 2023
Authors and Affiliates
Koji Izutsu1  Kazuhito Yamamoto2 Koji Kato3 Takayuki Ishikawa4 Noriko Fukuhara5 Yasuhito Terui6,7 Ilseung Choi8· Sumiko Okubo9 Natsumi Ogawa10 Mizu Sakai10 Yasuko Nishimura10 Brenda Chyla11 Yan Sun11 Dai Maruyama1,6 1 Department of Hematology, National Cancer Center Hospital, Tokyo, Japan2 Department of Hematology and Cell Therapy, Aichi Cancer Center, Aichi, Japan3 Department of Hematology, Oncology and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka, Japan4 Department of Hematology, Kobe City Medical Center General Hospital, Hyogo, Japan5 Department of Hematology, Tohoku University Hospital, Miyagi, Japan6 Department of Hematology Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan7 Department of Hematology, Saitama Medical University Hospital, Saitama, Japan8 Department of Hematology, National Hospital Organization, Kyushu Cancer Center, Fukuoka, Japan9 AbbVie GK, Osaka, Japan10 AbbVie GK, Tokyo, Japan11 AbbVie, Inc, North Chicago, IL, USA

Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results.

Lesokhin AM, et al.
Nature Medicine
August 2023
Authors and Affiliates
Alexander M. Lesokhin  1, Michael H. Tomasson2, Bertrand Arnulf3, Nizar J. Bahlis  4, H. Miles Prince  5, Ruben Niesvizky6, Paula Rodrίguez-Otero7, Joaquin Martinez-Lopez  8, Guenther Koehne9, Cyrille Touzeau10, Yogesh Jethava11, Hang Quach12, Julien Depaus13, Hisayuki Yokoyama14, Afshin Eli Gabayan15, Don A. Stevens16, Ajay K. Nooka  17, Salomon Manier18, Noopur Raje19, Shinsuke Iida20, Marc-Steffen Raab  21, Emma Searle22, Eric Leip23, Sharon T. Sullivan23, Umberto Conte24, Mohamed Elmeliegy25, Akos Czibere24, Andrea Viqueira26 & Mohamad Mohty27 1Division of Hematology and Oncology, Memorial Sloan Kettering Cancer Center/Weill Cornell Medical College, New York City, NY, USA. 2Department of Internal Medicine, University of Iowa, Iowa City, IA, USA. 3Hôpital Saint-Louis, Paris, France. 4Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, Alberta, Canada. 5Epworth Healthcare and University of Melbourne, Melbourne, Victoria, Australia. 6Weill Cornell Medical College/New York Presbyterian Hospital, New York City, NY, USA. 7Clinica Universidad de Navarra, Madrid, Spain. 8Hospital Universitario 12 de Octubre, Madrid, Spain. 9Miami Cancer Institute, Miami, FL, USA. 10University Hospital of Nantes, Nantes, France. 11Indiana Blood & Marrow Transplant, Indianapolis, IN, USA. 12University of Melbourne, St. Vincent’s Hospital Melbourne, Melbourne, Victoria, Australia. 13Université Catholique de Louvain, CHU UCL Namur, Yvoir, Belgium. 14Tohoku University Graduate School of Medicine, Sendai, Japan. 15Beverly Hills Cancer Center, Beverly Hills, CA, USA. 16Norton Cancer Center, Louisville, KY, USA. 17Winship Cancer Institute, Atlanta, GA, USA. 18Lille University Hospital and INSERM UMR-S1277, Lille, France. 19Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA. 20Department of Hematology & Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. 21Heidelberg Myeloma Center, Department of Hematology/Oncology, Heidelberg University Hospital, Heidelberg, Germany. 22The Christie Hospital, The University of Manchester, Manchester, UK. 23Pfizer Inc, Cambridge, MA, USA. 24Pfizer Inc, New York, NY, USA. 25Pfizer Inc, San Diego, CA, USA. 26Pfizer SLU, Madrid, Spain. 27Sorbonne University, Hôpital Saint-Antoine, and INSERM UMRs938, Paris, France.

Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma.

San-Miguel J, et al.
New England Journal of Medicine
July 2023
Authors and Affiliates
Jesús San-Miguel, M.D., Ph.D., Binod Dhakal, M.D., Kwee Yong, Ph.D., Andrew Spencer, M.D., Sébastien Anguille, M.D., Ph.D., María-Victoria Mateos, M.D., Ph.D., Carlos Fernández de Larrea, M.D., Ph.D., Joaquín Martínez-López, M.D., Philippe Moreau, M.D., Ph.D., Cyrille Touzeau, M.D., Xavier Leleu, M.D., Irit Avivi, M.D., Michele Cavo, M.D., Tadao Ishida, M.D., Ph.D., Seok Jin Kim, M.D., Ph.D., Wilfried Roeloffzen, M.D., Niels W.C.J. van de Donk, M.D., Ph.D., Dominik Dytfeld, M.D., Surbhi Sidana, M.D., Luciano J. Costa, M.D., Albert Oriol, M.D., Ph.D., Rakesh Popat, M.D., Ph.D., Abdullah M. Khan, M.B., B.S., Yaël C. Cohen, M.D., P. Joy Ho, M.B., B.S., D.Phil., James Griffin, Ph.D., Nikoletta Lendvai, M.D., Carolina Lonardi, Pharm.D., Ana Slaughter, Ph.D., Jordan M. Schecter, M.D., Carolyn C. Jackson, M.D., Kaitlyn Connors, B.S., Katherine Li, M.S., Enrique Zudaire, Ph.D., Diana Chen, M.S., Jane Gilbert, M.Sc., Tzu-min Yeh, M.S., Sarah Nagle, M.D., Erika Florendo, M.S., Lida Pacaud, M.D., Nitin Patel, B.M., B.Ch., Simon J. Harrison, Ph.D., and Hermann Einsele, M.D. The Cancer Center Clínica Universidad de Navarra, Centro Investigación Medica Aplicada, Instituto de Investigación de Navarra, Centro Investigación Biomédica en Red Cáncer (CIBERONC), Pamplona (J.S.-M.), the University Hospital of Salamanca, Instituto de Investigación Biomédica de Salamanca, Centro Investigación del Cáncer, CIBERONC, Salamanca (M.-V.M.), the Amyloidosis and Myeloma Unit, Department of Hematology, Hospital Clínic of Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona (C.F.L.), the Hematological Malignancies Clinical Research Unit, Hospital 12 de Octubre Universidad Complutense, Centro Nacional de Investigaciones Oncológicas, CIBERONC, Madrid (J.M.-L.), and the Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Badalona (A.O.) — all in Spain; the Medical College of Wisconsin, Milwaukee (B.D.); the University College London Cancer Institute (K.Y.) and University College London Hospitals, NHS Foundation Trust (R.P.), London, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol (J. Griffin), and Janssen Research and Development, High Wycombe (J. Gilbert) — all in the United Kingdom; Monash University (A. Spencer) and the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Sir Peter MacCallum Department of Oncology, University of Melbourne (S.J.H.), Melbourne, VIC, and Royal Prince Alfred Hospital and the University of Sydney, Sydney (P.J.H.) — all in Australia; the Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, and the Division of Hematology and Center for Cell Therapy and Regenerative Medicine, Antwerp University Hospital, Edegem — both in Belgium (S.A.); the Department of Hematology, University Hospital Hôtel-Dieu, Nantes (P.M., C.T.), and Service d’Hématologie et Thérapie Cellulaire, Hôpital La Milétrie, and Centre d’investigation Clinique INSERM 1402, Poitiers University Hospital, Poitiers (X.L.) — both in France; Tel Aviv Sourasky Medical Center (I.A., Y.C.C.) and the Sackler Faculty of Medicine, Tel Aviv University (Y.C.C.) — both in Tel Aviv, Israel; IRCCS Azienda Ospedaliero– Universitaria di Bologna, Seràgnoli Institute of Hematology, and the Department of Medical and Surgical Sciences, Bologna University School of Medicine, Bologna, Italy (M.C.); the Department of Hematology, Japanese Red Cross Medical Center, Tokyo (T.I.); the Division of Hematology–Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (S.J.K.); the Department of Hematology, University Medical Center Groningen, Groningen (W.R.), and Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam (N.W.C.J.D.) — both in the Netherlands; Poznan University of Medical Sciences, Poznan, Poland (D.D.); Stanford University School of Medicine, Stanford, CA (S.S.); the University of Alabama at Birmingham, Birmingham (L.J.C.); Ohio State University Comprehensive Cancer Center, Columbus (A.M.K.); Janssen Research and Development, Raritan (N.L., J.M.S., C.C.J., K.C., T.Y., S.N.), and Legend Biotech, Somerset (E.F., L.P., N.P.) — both in New Jersey; Janssen, Buenos Aires (C.L.); Cilag International, Zug, Switzerland (A. Slaughter); Janssen Research and Development, Spring House, PA (K.L., E.Z.); Janssen China Research and Development, Shanghai (D.C.); and Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, Germany (H.E.).

Time-dependent prognostic value of serological and measurable residual disease assessments after idecabtagene vicleucel.

Paiva B, et al.
Blood Cancer Discovery
July 2023
Authors and Affiliates
Bruno Paiva1, Irene Manrique1, Julie Rytlewski2, Timothy Campbell3, Christian C Kazanecki2, Nathan Martin2, Larry D. Anderson Jr.4, Jesús G Berdeja5, Sagar Lonial6, Noopur S Raje7, Yi Lin8, Philippe Moreau9, Jesús F. San-Miguel1, Nikhil C Munshi10, Shari Kaiser2 1Clinica Universidad de Navarra, CCUN, Centro de Investigacion Medica Aplicada (CIMA) , Instituto de Investigacion Sanitaria de Navarra (IDISNA), CIBERONC number CB16/12/00369, Pamplona, Spain; 2Bristol-Myers Squibb, Seattle, WA, USA; 3Bristol-Myers Squibb, San Francisco, CA, USA; 4Myeloma, Waldenström’s, and Amyloidosis Program, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX, USA; 5Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN, USA; 6Emory School of Medicine, Atlanta, GA, USA; 7Massachusetts General Hospital, Boston, MA, USA; 8Mayo Clinic, Rochester, MN, USA; 9Centre Hospitalier Universitaire de Nantes, Nantes, France; 10The LeBow Institute for Myeloma Therapeutics and Jerome Lipper Multiple Myeloma Center, DanaFarber Cancer Institute, Harvard Medical School, Boston, MA, USA

Isatuximab Plus Carfilzomib and Dexamethasone in East Asian Patients With Relapsed Multiple Myeloma: Updated IKEMA Subgroup Analysis

Kawano Y, et al.
Clinical Lymphoma Myeloma & Leukemia
July 2023
Authors and Affiliates
Yawara Kawano1, Kihyun Kim2, Chang Ki Min3, Youngil Koh4, Kenichi Ishizawa5, Sung Hyun Kim6, Shigeki Ito7, Junji Tanaka8, Michihiro Uchiyama9, Tadao Ishida10, Jin Seok Kim11, Philippe Moreau12, Thomas Martin13, Keisuke Tada14, Marie-Laure Risse15, Kenshi Suzuki16 1Department of Hematology, Kumamoto University Hospital, Kumamoto, Japan;2Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea;3Department of Hematology, Seoul St Mary’s Hospital, The Catholic University of Korea, Seoul, Republic of Korea;4Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea;5Department of Hematology and Cell Therapy, Yamagata University, Yamagata, Japan;6Department of Internal Medicine, Dong-A University College of Medicine, Busan, Republic of Korea;7Division of Hematology & Oncology, Department of Internal Medicine, Iwate Medical University School of Medicine, Yahaba, Japan;8Department of Hematology, Tokyo Women’s Medical University, Tokyo, Japan;9Department of Hematology, Japanese Red Cross Society, Suwa Hospital, Suwa, Japan;10Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan;11Department of Hematology, Severance Hospital, Seoul, Republic of Korea;12Department of Hematology, University Hospital of Nantes, 44093 Nantes, France;13Department of Medicine, University of California, San Francisco, CA;14Research and Development, Sanofi K.K., Tokyo, Japan;15Sanofi Research and Development, Vitry-sur-Seine, France;16Myeloma/Amyloidosis Center, Japanese Red Cross Medical Center, Tokyo, Japan

Efficacy and safety of isatuximab plus bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma ineligible/with no immediate intent for autologous stem cell transplantation.

Ocio EM, et al.
Leukemia
June 2023
Authors and Affiliates
Enrique M. Ocio 1, Aurore Perrot 2, Pierre Bories3, Jesus F. San-Miguel 4, Igor W. Blau5, Lionel Karlin6, Joaquin Martinez-Lopez7,Song-Yau Wang8, Sara Bringhen 9, Magda Marcatti10, María-Victoria Mateos 11, Paula Rodriguez-Otero 4, Stefania Oliva 12,Axel Nogai5, Nadia Le Roux13, Liyan Dong14, Sandrine Macé15, Matthieu Gassiot16, Thomas Fitzmaurice17, Corina Oprea18 and Philippe Moreau 1 1University Hospital Marqués de Valdecilla (IDIVAL), University of Cantabria, Santander, Spain. 2CHU de Toulouse, IUCT-O, Université de Toulouse, UPS, Service d’Hématologie,Toulouse, France. 3Toulouse University Institute of Cancer-Oncopole, Toulouse, France. 4Clinica Universidad de Navarra, CCUN, CIMA, IDISNA, CIBERONC, Pamplona, Spain. 5Charité Medical University, Berlin, Germany. 6Hôpital Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France. 7Hospital 12 de Octubre, Complutense University, CNIO, Madrid, Spain. 8Department of Hematology and Oncology, University of Leipzig, Leipzig, Germany. 9SSD Clinical Trial in Oncoematologia e Mieloma Multiplo, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy. 10Vita-Salute San Raffaele University, Milan, Italy. 11University Hospital of Salamanca, IBSAL, CSIC/CIC, Salamanca, Spain. 12Dipartimento di Oncologia ed Ematologia SC Ematologia 1 U, Torino, Italy. 13Sanofi Research & Development on behalf of Altran, Vitry-sur-Seine, France. 14Sanofi, Beijing, China. 15Sanofi Translational Medicine, Chilly-Mazarin, France. 16Sanofi Research & Development on behalf of Excelya, Montpellier, France. 17Sanofi, Cambridge, MA, USA. 18Sanofi Oncology, Vitry-sur-Seine, France. 19University of Nantes, Nantes, France.

Prospective evaluation of minimal residual disease in the phase II FORTE trial: a head-to-head comparison between multiparameter flow cytometry and next-generation sequencing

Oliva S, et al.
The Lancet
June 2023
Authors and Affiliates
Stefania Oliva,a Elisa Genuardi,b Laura Paris,c Mattia D’Agostino,a,b Jennifer Rogers,d Delia Rota-Scalabrini,e Allison P. Jacob,f Francesca Patriarca,gMario Luppi,h Paola Bertazzoni,i Cristina Velluti,b Andrea Capra,b Elona Saraci,b Marco Rossi,j Alessandro Allegra,k Roberto Mina,a,b Massimo Gentile,l Ilan R. Kirsch,f Angelo Belotti,m Michele Cavo,n,o Benedetto Bruno,a,b Pellegrino Musto,p,q Mario Boccadoro,b Elena Zamagni,n,o and Francesca Gaya,b aDivision of Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy bDivision of Hematology, Department of Molecular Biotechnology and Health Sciences, University of Torino, Torino, Italy cDivision of Hematology, ASST Papa Giovanni XXIII, Bergamo, Italy dMultiple Myeloma Research Foundation (MMRF), Norwalk, CT, USA eMultidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO - IRCCS, Torino, Italy fAdaptive Biotechnologies, Seattle, WA, USA gHematologic Clinic and Transplant Center, University Hospital of Central Friuli, DAME, University of Udine, Udine, Italy hDipartimento di Scienze Mediche e Chirurgiche Materno Infantili e dell’Adulto, UNIMORE, UOC Ematologia, Azienda OspedalieroUniversitaria di Modena, Modena, Italy iASST Grande Ospedale Metropolitano Niguarda, Milano, Italy jSOC Ematologia, Department of Oncology/Hematology, Azienda Ospedaliera Pugliese-Ciaccio and Department of Experimental and Clinical Medicine, Magna Graecia University, Catanzaro, Italy kDivision of Hematology, Department of Human Pathology in Adulthood and Childhood “Gaetano Barresi”, University of Messina, Messina, Italy lUOC Ematologia, AO Cosenza, Cosenza, Italy mDepartment of Hematology, ASST Spedali Civili di Brescia, Brescia, Italy nIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli”, Bologna, Italy oDipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy pDepartment of Precision and Regenerative Medicine and Ionian Area, “Aldo Moro” University School of Medicine, Bari, Italy qHematology and Stem Cell Transplantation Unit, AOU Consorziale Policlinico, Bari, Ital

Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study.

Siddiqi T, et al.
The Lancet
June 2023
Authors and Affiliates
Tanya Siddiqi, David G Maloney, Saad S Kenderian, Danielle M Brander, Kathleen Dorritie, Jacob Soumerai, Peter A Riedell, Nirav N Shah, Rajneesh Nath, Bita Fakhri, Deborah M Stephens, Shuo Ma, Tatyana Feldman, Scott R Solomon, Stephen J Schuster, Serena K Perna, Sherilyn A Tuazon, San-San Ou, Eniko Papp, Leanne Peiser, Yizhe Chen, William G Wierda Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA, USA (T Siddiqi MD);Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA (Prof D G Maloney MD); Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA(S S Kenderian MBChB); Division of Hematologic Malignancies & Cellular Therapy, Duke University Health System, Durham, NC, USA(D M Brander MD); Division of Hematology/Oncology, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA(K Dorritie MD); Department of Medicine, Center for Lymphoma, Massachusetts General Hospital Cancer Center, Boston, MA, USA(J Soumerai MD); Section of Hematology/Oncology, Department of Medicine, The David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago, IL, USA(P A Riedell MD); Cancer Center, Froedtert Hospital, Medical College of Wisconsin, Milwaukee, WI, USA(N N Shah MD); Stem Cell Transplantation Cellular Therapy and Acute Leukemia, Banner MD Anderson Cancer Center, Gilbert, AZ, USA(R Nath MD); Department of Medicine, Division of Hematology and Blood and Marrow Transplant, University of California San Francisco, San Francisco, CA, USA(B Fakhri MD); Internal Medicine and Division of Hematology and Hematologic Malignancies, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA(D M Stephens DO); Hematology and Oncology, Robert H Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, USA(Prof S Ma MD); T Cell Lymphoma Program, John Theurer Cancer Center at Hackensack Meridian Health, Hackensack Meridian Health School of Medicine, Hackensack, NJ, USA (T Feldman MD); Transplant and Cellular Immunotherapy Program, Northside Hospital Cancer Institute, Atlanta, GA, USA (S R Solomon MD);Lymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA(Prof S J Schuster MD); Bristol Myers Squibb, Princeton, NJ, USA (S K Perna MD, Y Chen PhD);Bristol Myers Squibb, Seattle, WA, USA (S A Tuazon MD, S-S Ou MS, E Papp PhD, L Peiser DPhil); Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA(Prof W G Wierda MD)

Impact of Minimal Residual Disease on Progression-Free Survival Outcomes After Fixed-Duration Ibrutinib-Venetoclax Versus Chlorambucil-Obinutuzumab in the GLOW Study.

Munir T, et al.
Journal of Clinical Oncology
June 2023
Authors and Affiliates
Talha Munir, MBBS1 ; Carol Moreno, MD2; Carolyn Owen, MD3; George Follows, PhD4; Ohad Benjamini, MD5; Ann Janssens, MD, PhD6;Mark-David Levin, MD7 ; Anders Osterborg, MD, PhD8; Tadeusz Robak, MD, PhD9 ; Martin Simkovic, MD, PhD10 ; Don Stevens, MD11;Sergey Voloshin, MD, PhD12; Vladimir Vorobyev, PhD13 ; Munci Yagci, MD14; Loic Ysebaert, MD, PhD15 ; Keqin Qi, PhD16 ; Qianya Qi, PhD17;Lori Parisi, MPH17; Srimathi Srinivasan, PhD18 ; Natasha Schuier, MD19; Kurt Baeten, PhD20; Angela Howes, PhD21;Donne Bennett Caces, MD, PhD17; Carsten U. Niemann, MD, PhD22 ; and Arnon P. Kater, MD, PhD23 1 St James’s Hospital, Leeds, United Kingdom 2; Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Josep Carreras Research Leukaemia Research Institute, Barcelona, Spain3; Tom Baker Cancer Centre, Calgary, Canada 4;Addenbrookes Hospital, Cambridge, United Kingdom 5;Sheba Medical Center, Ramat Gan, Israel 6; UZ Leuven Gasthuisberg, Leuven, Belgium 7;Albert Schweitzer Hospital, Dordrecht, the Netherlands 8; Karolinska University Hospital, Stockholm, Sweden 9; Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland 10; University Hospital Hradec Kralove, Hradec Kralove, Czech Republic 11;Norton Cancer Institute, Louisville, KY 12; Russian Scientific and Research Institute of Hematology and Transfusiology, St Petersburg, Russia 13; S.P. Botkin Moscow City Clinical Hospital, Moscow, Russia 14; Gazi Universitesi Tip Fakultesi, Ankara, Turkey 15; Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France 16; Janssen Research & Development, Titusville, NJ 17; Janssen Research & Development, Raritan, NJ 18; Oncology Translational Research, Janssen Research & Development, Lower Gwynedd Township, PA 19; Janssen Research & Development, Dusseldorf, Germany ¨20; Janssen Research & Development, Beerse, Belgium 21;Janssen Research & Development, High Wycombe, United Kingdom 22; Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark 23; Amsterdam Medical Centers, University of Amsterdam, Amsterdam, the Netherlands