Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study
Phase 2N = 90NCT02500407
- Population
- Follicular lymphoma (grade 1 to 3a), relapsed or refractory after two or more prior therapies; 90 patients enrolled.
- Design
- Single-arm, multicentre phase 2 study at 49 centres in seven countries of fixed-duration intravenous mosunetuzumab (cycle 1 step-up dosing 1 mg, 2 mg, then 60 mg; 30 mg from cycle 3; 21-day cycles; 8 cycles for patients in complete response and up to 17 cycles otherwise) in follicular lymphoma (grade 1 to 3a) relapsed or refractory after two or more prior therapies including an anti-CD20 antibody and an alkylating agent. Primary endpoint: independent review committee-assessed complete response rate in all enrolled patients, compared with a 14% historical control rate with copanlisib. 90 patients were enrolled.
- Primary endpoint
- CR rate
- Arms
- Mosunetuzumab (experimental, n = 90): Intravenous mosunetuzumab, 21-day cycles with cycle 1 step-up dosing (1 mg, 2 mg, 60 mg), then 30 mg from cycle 3; 8 to 17 cycles
- People
- Budde LE
Show the numbers
| Endpoint | Analysis | Mosunetuzumab | Control | Effect |
|---|---|---|---|---|
| CR rateAll enrolled patients (90) | primarymedian follow-up 18.3 monthsBudde 2022 | 60% (49.1–70.2%) | — | P<0.0001Independent review committee assessment, best response; 54 of 90 patients. P value is versus the 14% historical control rate. |
| Endpoint | Analysis | Mosunetuzumab | Control | Effect |
|---|---|---|---|---|
| CR rateAll enrolled patients (90) | primarymedian follow-up 18.3 monthsBudde 2022 | 60% (49.1–70.2%) | — | P<0.0001Independent review committee assessment, best response; 54 of 90 patients. P value is versus the 14% historical control rate. |