Roche: CELESTIMO Phase III shows PFS benefit for Lunsumio plus lenalidomide
- Interim analysis of Phase III CELESTIMO met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression‑free survival for Lunsumio plus lenalidomide versus rituximab plus lenalidomide.
- Study population: patients with relapsed or refractory follicular lymphoma receiving second‑line or later therapy.
- Lunsumio was evaluated as intravenous infusion formulations of 1 mg and 30 mg in combination with oral lenalidomide; the comparator was rituximab plus lenalidomide.
- Safety of the combination was consistent with known profiles of the individual medicines with no new safety signals identified; detailed results will be presented at an upcoming medical meeting.
Study results
The global Phase III CELESTIMO study compared Lunsumio (mosunetuzumab) intravenous infusion (1 mg and 30 mg) plus lenalidomide against rituximab plus lenalidomide in patients with relapsed or refractory follicular lymphoma receiving second‑line or later therapy. An interim analysis met the study's primary endpoint, showing a statistically significant and clinically meaningful improvement in progression‑free survival for the Lunsumio plus lenalidomide arm versus the rituximab plus lenalidomide control.
Safety
The safety profile observed for the Lunsumio and lenalidomide combination was consistent with the known safety profiles of the individual medicines and no new safety signals were identified in the interim analysis.
Next steps and regimen details
Detailed results from the CELESTIMO study are planned for presentation at an upcoming medical meeting. The trial evaluated a regimen combining an injectable Lunsumio formulation with oral lenalidomide, offering a fixed treatment duration and a simple dosing schedule as described in the release.
Source: Chugai Pharmaceutical