Mosunetuzumab Plus Polatuzumab Vedotin in Transplant-Ineligible Refractory/Relapsed Large B-Cell Lymphoma: Primary Results of the Phase III SUNMO Trial
Abstract
PURPOSE Prognosis for patients with refractory/relapsed large B-cell lymphoma (LBCL) considered ineligible for curative-intent therapy is poor. The combination of mosunetuzumab, a T-cell–engaging bispecific antibody, and polatuzumab vedotin, an antibody-drug conjugate (Mosun-Pola), represents a novel fixed-duration outpatient therapy. METHODS In the phase III SUNMO trial, patients with refractory/relapsed LBCL who were ineligible for autologous stem-cell transplant were randomly assigned (2:1) to receive Mosun-Pola or rituximab, gemcitabine, and oxaliplatin (R-GemOx). Dual primary end points were centrally assessed overall response rate (ORR) and progression-free survival (PFS). Overall survival was a key secondary end point. RESULTS A total of 208 patients were randomly assigned to receive Mosun-Pola (n = 138) or R-GemOx (n = 70). At a median follow-up of 23.2 months, the primary analysis of SUNMO demonstrated that the median PFS was significantly longer with Mosun-Pola than with R-GemOx (11.5 months [95% CI, 5.6 to 18] v 3.8 months [95% CI, 2.9 to 4.1]; hazard ratio for progression or death, 0.41 [95% CI, 0.3 to 0.6]; P < .0001). ORR was significantly greater with Mosun-Pola versus R-GemOx (70% v 40%; P < .0001), with complete response rates of 51% and 24%, respectively. In the Mosun-Pola group, the rate of grade ≥2 cytokine release syndrome (CRS) and usage of tocilizumab occurred in <5% of patients and patient-reported outcomes were improved compared with R-GemOx. CONCLUSION Mosun-Pola demonstrated superior efficacy versus R-GemOx, with significant improvements in both ORR and PFS, and infrequent CRS events with a manageable safety profile.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (86)
Lihua E. Budde
1City of Hope National Medical Center, Duarte, CA
Won-Seog Kim
17Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
Eduardo M. Rego
5Instituto D'Or de Pesquisa e Ensino, Sao Paulo, Brazil
Danielle Leão Cordeiro de Farias
Hospital Beneficência Portuguesa de São Paulo, São Paulo, Brazil
Adam J. Olszewski
10Department of Medicine, Brown University, Providence, RI
Nikesh Shah
1Tampa General Hospital Cancer Institute, Tampa, United States
Shen Yin
Hao Wu
Iris To
12Genentech, Inc, South San Francisco, CA
Wahib S. Ead
11Genentech, Inc., South San Francisco, United States
Joan Ashby
12Genentech, Inc., South San Francisco, United States
Martin Janousek
13F. Hoffmann-La Roche Ltd, Basel, United States
Song Pham
13Hoffmann-La Roche Ltd, Mississauga, ON, Canada
Jue Wang
Beijing National Laboratory for Molecular Sciences, College of Chemistry and Molecular Engineering
Antonia Kwan
12Genentech, Inc, South San Francisco, CA
Connie L. Batlevi
11Genentech, Inc., South San Francisco, United States
Michael C. Wei
12Genentech, Inc, South San Francisco, CA
Astrid Pavlovsky
6Fundaleu, Buenos Aires, Argentina
Dorotea Fantl
7Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, Buenos Aires, Argentina
Carolina Valeria Mahuad
Maria Custidiano
44Instituto Alexander Fleming (IAF), Buenos Aires, Argentina
Laura Maria Fogliatto
11Department of Clinical Hematology, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil
Eduardo Rego
Diego Villa Cle
Joao Farias
Danielle Farias
John Kuruvilla
1Princess Margaret Cancer Centre
Stephane Doucet
Mark Bosch
Gwynivere Davies
1McMaster University, Department of Oncology, Hamilton, Canada
Huilai Zhang
Xiaoxi Zhou
Organometallic Chemistry Laboratory, RIKEN Pioneering Research Institute, 2-1 Hirosawa, Wako, Saitama 351-0198, Japan
Huangming Hong
2Sichuan Cancer Hospital & Institute, Chengdu, China
Li Yu
Jianzhen Shen
Yanyan Liu
College of Chemistry and Materials
Hongyan Tong
Zhiming Li
Itai Levi
5Soroka Medical Center, Hematology, Beer Sheva, Israel
Uri Abadi
12Meir Medical Center, Hematology, Kfar Saba, Israel
Irit Avivi
From Tel Aviv Sourasky Medical Center (Y.C.C., I.A.), and the Faculty of Medical and Health Sciences, Tel Aviv University (Y.C.C., H.M., I.A.), Tel Aviv, Chaim Sheba Medical Center, Ramat Gan (H.M.), and Hadassah Hebrew University Medical Center, Jerusalem (M.G.) — all in Israel; McGill University and McGill University Health Centre, Montreal (M.S.), and Alberta Health Services, Edmonton (M.P.C.) — all in Canada; Samsung Medical Center, Sungkyunkwan University School of Medicine (K.K.), Seoul St. Mary’s Hospital, Catholic University of Korea (C.-K.M.), and Seoul National University College of Medicine (S.-S.Y.) — all in Seoul, South Korea; Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Universidad de Cantabria, Santander (E.M.O.), Cancer Center Clínica Universidad de Navarra, Center for Applied Medical Research, Pamplona (P.R.-O.), Institut Català d’Oncologia, Josep Carreras Leukemia Research Institute, and the Hospital Germans Trias i Pujol, Barcelona (A.O.)...
Keiko Aizawa
Dai Maruyama
Cancer Institute Hospital, Japanese Foundation for Cancer Research, Koto-ku, Tokyo
Yoshiaki Ogawa
24Tokai University of School of Medicine, Kanagawa, Japan
Takahiro Kumode
15Kindai University, Department of Hematology and Rheumatology, Osaka, Japan
Noriko Fukuhara
1Tohoku University Graduate School of Medicine, Hematology, Sendai, Japan
Motoko Yamaguchi
Hideki Goto
Koji Kato
Tadakazu Kondo
1Kobe City Medical Center General Hospital, Hematology, Kobe, Japan
Tae Min Kim
Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
Won Seog Kim
Ho-jin Shin
Pusan National University Hospital, Busan, Korea, Republic of
Young-Woo Jeon
Yeouido St Mary's Hospital, Seoul, Republic of Korea
Jin Seok Kim
10Yonsei University College of Medicine, Severance Hospital, Seoul, Korea
Myungwon Lee
Chungnam National University Hospital, Jung-Gu, South Korea
Luis Rubalcava
David Gomez Almaguer
Gladys Patricia Agreda Vasquez
Juan Manuel Perez Zuniga
Gilberto Barranco Lampon
Samar Issa
Cesar Samanez
Luz Ventura
Archrob Khuhapinant
7Siriraj Hospital, Bangkok, Thailand
Kitsada Wudhikarn
Lalita Norasetthada
Chinadol Wanitpongpun
Mehmet Turgut
Ondokuz Mayıs University, Samsun, Turkey
Senem Maral
Department of Hematology, Faculty of Medicine, Istanbul Medipol University, Istanbul, Turkey
Inci Alacacioglu
Zafer Gulbas
14Anadolu Medical Center Hospital, Kocaeli, Türkiye
Muhit Ozcan
14Ankara University School of Medicine, Ankara, Türkiye
Ashraf Aziz
Elizabeth Budde
City of Hope National Medical Center, Duarte, CA
Adam Olszewski
Jason Westin
3Department of Lymphoma and Myeloma, MD Anderson Cancer Center, Houston, TX
Mark Fesler
9St. Luke's Hospital, Chesterfield, United States
Ruemu Birhiray
1Indy Hematology Education Inc, Carmel, United States
Nihal Abdulla
Steven Liu
Analysis Group, Inc., Boston, MA
Bei Hu
Zaw Myint
Boone Goodgame
9Dell Medical School, University of Texas at Austin, Austin, United States
Izidore Lossos
Jason Salganick