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

Phase 3 Active, not recruiting NCT05171647

Condition	Non-Hodgkin Lymphoma
Phase	Phase 3
Sponsor	Hoffmann-La Roche
Status	Active, not recruiting
Enrollment	208 participants
Interventions	Mosunetuzumab, Polatuzumab vedotin, Tocilizumab, Rituximab, Gemcitabine
Start date	Apr 25, 2022
Completion date	Feb 17, 2025
Results posted	Mar 6, 2026

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).

Objective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP)

Up to approximately 23.8 months · percentage of participants

Arm A: Mosun-Pola	69.7 percentage of participants
Arm B: R-GemOx	44.1 percentage of participants

p-value	0.0008
Difference in Overall Response Rates	25.68 (95% CI 9.60–41.76)

Progression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans

Up to 32 months · months

Arm A: Mosun-Pola	11.5 months
Arm B: R-GemOx	3.8 months

p-value	<0.0001
Hazard Ratio (HR)	0.41 (95% CI 0.28–0.61)

Open in BENITIONS View on ClinicalTrials.gov

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This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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