Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial

Lihua E. Budde, Adam J. Olszewski, Sarit Assouline, Izidore S. Lossos, Catherine Diefenbach, Manali Kamdar, Nilanjan Ghosh, Dipenkumar Modi, Waleed Sabry, Seema Naik, Amitkumar Mehta, Shazia K. Nakhoda, Stephen D. Smith, Kathleen Dorritie, Ting Jia, Song Pham, Ling Yuh Huw, Jing Jing, Hao Wu, Wahib S. EadIris To, Connie Lee Batlevi, Michael C. Wei, Julio C. Chavez

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6 Scopus citations


Relapsed/refractory aggressive large B cell lymphoma (LBCL) remains an area of unmet need. Here we report the primary analysis of a phase 1b/2 trial of outpatient mosunetuzumab (a CD20xCD3 T-cell-engaging bispecific antibody) plus polatuzumab vedotin (an anti-CD79B antibody–drug conjugate) in relapsed/refractory LBCL. The phase 2 component is a single arm of an ongoing multi-arm trial. The primary endpoint during dose expansion was independent review committee (IRC)-assessed best overall response rate. Secondary endpoints included investigator-assessed overall response rate, complete response, duration of response, progression-free survival and overall survival. At data cutoff, 120 patients were enrolled (22 dose escalation, 98 dose expansion). The primary endpoint was met during dose expansion, with IRC-assessed best overall response rate and complete response rates of 59.2% (58/98; 95% confidence interval (CI): 48.8–69.0) and 45.9% (45/98; 95% CI: 35.8–56.3), respectively (median follow-up, 23.9 months). Median duration of complete was not reached (95% CI: 20.5–not estimable (NE)). Median progression-free survival was 11.4 months (95% CI: 6.2–18.7). Median overall survival was 23.3 months (95% CI: 14.8–NE). Across dose escalation and expansion, the most common grade 3 or higher adverse events were neutropenia (25.0%, 30/120) and fatigue (6.7%, 8/120). Any-grade cytokine release syndrome occurred in 16.7% of patients. These data demonstrate that mosunetuzumab plus polatuzumab vedotin has a favorable safety profile with highly durable responses suitable as second-line therapy in transplant-ineligible relapsed/refractory LBCL. identifier: NCT03671018 .

Original languageEnglish (US)
Pages (from-to)229-239
Number of pages11
JournalNature Medicine
Issue number1
StatePublished - Jan 2024

All Science Journal Classification (ASJC) codes

  • General Biochemistry, Genetics and Molecular Biology

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