A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Summary
This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).
Timeline
- Start
- 2022-04-25
- Primary completion
- 2025-02-17
- Completion
- 2027-02-28
Outcome
Met primary endpoint
registry analysis (superiority test); Arm A: Mosun-Pola vs Arm B: R-GemOx; p = 0.0008; Difference in Overall Response Rates 25.68 (95% CI 9.60 to 41.76); Cochran-Mantel-Haenszel NCT05171647 ↗
registry analysis (superiority test); Arm A: Mosun-Pola vs Arm B: R-GemOx; p <0.0001; Hazard Ratio (HR) 0.41 (95% CI 0.28 to 0.61); Log Rank NCT05171647 ↗
release “Pivotal Phase III SUNMO study demonstrated an 11.5 month median progression-free survival – three times longer than R-GemOx” gene.com ↗
release “demonstrated a clinically meaningful and statistically significant improvement in its primary endpoints of progression-free survival (PFS) and objective response rate (ORR)” gene.com ↗
release “Mosunetuzumab plus polatuzumab vedotin is superior to R-GemOx in transplant-ineligible patients with R/R LBCL: primary results of the Phase III SUNMO trial.” roche.com ↗
release “Genentech’s Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-Cell Lymphoma” gene.com ↗
Publications
- Maruyama D, Goto H, Kumode T, Aizawa K, Fukuhara N, Westin JR, Kim WS, Mori C, Imaizumi T, Kato K. Efficacy and safety of subcutaneous mosunetuzumab plus polatuzumab vedotin in patients with relapsed/refractory large B-cell lymphoma: Japan subgroup analysis of the phase III SUNMO trial. Int J Clin Oncol. 2026 Jun 15. doi: 10.1007/s10147-026-03042-x. Online ahead of print.
- Chavez JC, Bastos-Oreiro M, Diefenbach C, Lossos IS, Shah N, Assouline S, Olszewski AJ, Naik S, Ghosh N, Pham S, Wei MC, Batlevi C, To I, Ead W, Makadia S, Penuel E, Jing J, Budde LE. A Randomized Phase II Study of Subcutaneous Mosunetuzumab in Combination With Polatuzumab Vedotin Compared With Rituximab Plus Polatuzumab Vedotin in Patients With Relapsed or Refractory Large B-Cell Lymphoma. Am J Hematol. 2026 Jun 12. doi: 10.1002/ajh.70403. Online ahead of print.
- Budde LE, Zhang H, Kim WS, Maruyama D, Rego EM, Norasetthada L, Hong H, Ozcan M, Jeon YW, Leao Cordeiro de Farias D, Fogliatto LM, Pavlovsky A, Goto H, Olszewski AJ, Shah N, Hu B, Yin S, Wu H, To I, Ead WS, Ashby J, Janousek M, Pham S, Wang J, Kwan A, Batlevi CL, Wei MC, Westin J. Mosunetuzumab Plus Polatuzumab Vedotin in Transplant-Ineligible Refractory/Relapsed Large B-Cell Lymphoma: Primary Results of the Phase III SUNMO Trial. J Clin Oncol. 2025 Dec 20;43(36):3799-3811. doi: 10.1200/JCO-25-01957. Epub 2025 Oct 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | — | Intravenous |
| Subject | Mosunetuzumab | Monoclonal antibody | — | Subcutaneous |
| Comparator | Oxaliplatin | Small molecule | — | Intravenous |
| Subject | Polatuzumab Vedotin | Other / unclassified | — | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | — | Intravenous |
| Background | Tocilizumab | Monoclonal antibody | — | Intravenous |