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.
[1]City Hope Natl Med Ctr, Duarte, CA USA
[2]Tianjin Med Univ, Canc Inst, Tianjin, Peoples R China
[3]Samsung Med Ctr, Seoul, South Korea
[4]Japanese Fdn Canc Res, Canc Inst Hosp, Tokyo, Japan
[5]Inst DOr Pesquisa & Ensino, Sao Paulo, Brazil
[6]Chiang Mai Univ, Chiang Mai, Thailand
[7]Si Chuan Canc Hosp, Chengdu, Peoples R China
[8]Ankara Univ, Sch Med, Ankara, Turkiye
[9]Yeouido St Marys Hosp, Seoul, South Korea
[10]Hosp Beneficencia Portuguesa Sao Paulo, Sao Paulo, Brazil
[11]Hosp Clin Porto Alegre, Porto Alegre, Brazil
[12]Fundaleu, Buenos Aires, Argentina
[13]Hokkaido Univ Hosp, Dept Hematol, Sapporo, Japan
[14]Brown Univ, Providence, RI USA
[15]Tampa Gen Hosp, Canc Inst, Tampa, FL USA
[16]Atrium Hlth Levine Canc Inst, Charlotte, NC USA
[17]Wake Forest Sch Med, Charlotte, NC USA
[18]Genentech Inc, South San Francisco, CA USA
[19]F Hoffmann La Roche Ltd, Basel, Switzerland
[20]Hoffmann La Roche Ltd, Mississauga, ON, Canada
[21]MD Anderson Canc Ctr, Houston, TX 77030 USA
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