Mosunetuzumab plus polatuzumab vedotin in transplant-ineligible refractory/relapsed large B-cell lymphoma: primary results of the phase 3 SUNMO trial
Lihua E. Budde, Huilai Zhang, Won-Seog Kim, Dai Maruyama, Eduardo M. Rego, Lalita Norasetthada, Huangming Hong, Muhit Ozcan, Young-Woo Jeon, Danielle Leão Cordeiro de Farias, Laura Maria 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 L. Batlevi, Michael C. Wei, Jason WestinPURPOSE
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 3 SUNMO trial, patients with refractory/relapsed LBCL who were ineligible for autologous stem cell transplant were randomized (2:1) to receive Mosun-Pola or rituximab, gemcitabine, and oxaliplatin (R-GemOx). Dual primary endpoints were centrally-assessed overall response rate and progression-free survival. Overall survival was a key secondary endpoint.
RESULTS
A total of 208 patients were randomized 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 progression-free survival was significantly longer with Mosun-Pola than with R-GemOx
(11.5 months [95% confidence interval (CI), 5.6–18] vs 3.8 months [95% CI, 2.9–4.1]; hazard ratio for progression or death, 0.41 [95% CI, 0.3–0.6]; P<0.0001). Overall response rate was significantly greater with Mosun-Pola versus R-GemOx (70% vs 40%; P<0.0001), with a complete response rate of 51% and 24%, respectively. In the Mosun-Pola group, the rate of grade ≥2 cytokine release syndrome and usage of tocilizumab occurred in less than 5% of patients, and patient-reported outcomes were improved compared with R-GemOx.
CONCLUSION
Mosun-Pola demonstrated superior efficacy verus R-GemOx, with significant improvements in both overall response rate and progression-free survival, and infrequent cytokine release syndrome events with a manageable safety profile.
(Funded by F. Hoffmann-La Roche Ltd;