Roche: Lunsumio plus lenalidomide improves PFS in relapsed/refractory follicular lymphoma
- Phase III CELESTIMO met its primary endpoint at interim analysis, showing a statistically significant and clinically meaningful reduction in risk of progression for follicular lymphoma patients with ≥1 prior systemic therapy.
- Overall survival data were immature at the time of the interim analysis.
- Safety of the Lunsumio plus lenalidomide combination was consistent with known profiles of the individual medicines; no new safety signals were identified.
- Lunsumio is part of Roche’s CD20xCD3 bispecific programme, already approved for 3L+ FL in 60 countries and used in over 3,800 patients; CELESTIMO data will be submitted to regulators and presented at a medical meeting.
CELESTIMO primary result
The phase III CELESTIMO study comparing Lunsumio (mosunetuzumab) plus lenalidomide versus rituximab plus lenalidomide in people with relapsed or refractory follicular lymphoma who had received at least one prior systemic therapy met its primary endpoint at an interim analysis, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival. Overall survival data were immature at the time of the interim analysis.
Safety and administration
The safety profile of the Lunsumio and lenalidomide combination was reported as consistent with the known profiles of the individual medicines and no new safety signals were identified. Roche notes the regimen offers outpatient administration, a simple dosing schedule and flexibility between intravenous and subcutaneous routes.
Regulatory and development context
CELESTIMO is a confirmatory study required to convert the accelerated approval/conditional marketing authorisation of Lunsumio monotherapy for third-line or later follicular lymphoma to full approval and to secure an indication in second-line or later disease. Roche will submit the CELESTIMO data to health authorities and present the results at an upcoming medical meeting. Lunsumio is already approved for 3L+ FL in 60 countries and has been used in over 3,800 patients.
Broader programme
Lunsumio is a CD20xCD3 T‑cell engaging bispecific antibody designed to redirect a patient’s T cells against malignant B cells. Roche’s clinical programme for Lunsumio spans multiple settings, including ongoing studies such as the phase III MorningLyte trial in first-line FL and a submitted sBLA for Lunsumio plus polatuzumab vedotin in second-line or later DLBCL based on the SUNMO study.
Source: Roche
