Mosunetuzumab Plus Polatuzumab Vedotin in Transplant-Ineligible Refractory/Relapsed Large B-Cell Lymphoma: Primary Results of the Phase III SUNMO Trial
Lihua E. Budde, Huilai Zhang, Won Seog Kim, Dai Maruyama, Eduardo Magalhães Rego, Lalita Norasetthada, Huangming Hong, Muhıt Özcan, Young‐Woo Jeon, Danielle Leão Cordeiro de Farias, Laura Fogliatto, Astrid Pavlovsky, Hideki Goto, Adam J. Olszewski, Nikesh Shah, Bei Hu, Shen Yin, Hao Wu, Iris To, Wahib S. Ead, Joan Ashby, Martin Janousek, Song Pham, Jue Wang, Antonia Kwan, Connie Lee Batlevi, Michael C. Wei, Jason R. Westin, Astrid Pavlovsky, Dorotea Fantl, Carolina Valeria Mahuad, Maria Custidiano, Laura Maria Fogliatto, Eduardo Rego, Diego Villa Cle, Joao Farias, Danielle Farias, John Kuruvilla, Stephane Doucet, Mark Bosch, Gwynivere Davies, Huilai Zhang, Xiaoxi Zhou, Huangming Hong, Li Yu, Jianzhen Shen, Yanyan Liu, Hongyan Tong, Zhiming Li, Itai Levi, Uri Abadi, Irit Avivi, Keiko Aizawa, Dai Maruyama, Yoshiaki Ogawa, Takahiro Kumode, Noriko Fukuhara, Motoko Yamaguchi, Hideki Goto, Koji Kato, Tadakazu Kondo, Tae Min Kim, Won Seog Kim, Ho-Jin Shin, Young-Woo Jeon, Jin Seok Kim, Myungwon Lee, Luis Rubalcava, David Gomez Almaguer, Gladys Patricia Agreda Vasquez, Juan Manuel Perez Zuniga, Gilberto Barranco Lampon, Samar Issa, Cesar Samanez, Luz Ventura, Archrob Khuhapinant, Kitsada Wudhikarn, Lalita Norasetthada, Chinadol Wanitpongpun, Mehmet Turgut, Senem Maral, Inci Alacacioglu, Zafer Gulbas, Muhit Ozcan, Ashraf Aziz, Elizabeth Budde, Adam Olszewski, Jason Westin, Mark Fesler, Ruemu Birhiray, Nihal Abdulla, Steven Liu, Bei Hu, Zaw Myint, Boone Goodgame, Izidore Lossos, Jason Salganick
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.