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Mosunetuzumab monotherapy in patients with R/R FL after ≥2 prior lines of therapies: 3-year follow-up results from the phase II trial
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A phase II trial (NCT02500407) assessed the safety and efficacy of mosunetuzumab, a CD20×CD3 T-cell-engaging bispecific antibody, in patients with R/R FL after ≥2 prior lines of therapy.1 Based on results from this trial, mosunetuzumab was approved by the FDA and the European Commission for the treatment of patients with R/R FL after ≥2 prior lines of therapy. The 3-year follow-up results of this trial were presented at the SOHO 2024 Annual Meeting by Schuster.1 The data cut-off was May 2, 2023, and study endpoints were PFS, OS, DoR, safety, and uMRD.1 |
| Key learnings |
| With a median follow-up of >3 years, mosunetuzumab achieved long-lasting remissions, with 3-year PFS and OS rates of 43.2% and 82.4%, respectively. The median DOR was 35.9 months and the 30-month DOR rate was 56.6%. |
| No new safety signals were reported during this long-term follow-up. The most common AEs and mosunetuzumab-related AEs with an incidence of ≥15% were CRS (44%; all resolved), fatigue, and headache; these were mostly Grade 1 or 2. |
| MRD analysis showed early deep molecular responses. Among patients achieving CR, uMRD was attained at C4 and C8 in 93% and 100% of patients, respectively. |
| Exploratory analysis showed detectable B-cell recovery at a median time of 18.4 months after the end of treatment. |
| Data from the pivotal phase II trial demonstrate the durable clinical efficacy and tolerable safety of mosunetuzumab monotherapy, supporting its use in patients with R/R FL after ≥2 prior lines of therapy. |
Abbreviations: AE, adverse event; C, cycle; CR, complete response; DoR, duration of response; FDA, U.S. Food and Drug Administration; FL, follicular lymphoma; MRD, minimal residual disease; OS, overall survival; PFS, progression-free survival; R/R, relapsed and refractory; SOHO, Society of Hematologic Oncology; uMRD, undetectable MRD.
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