Roche Announces Phase III CELESTIMO Study Results for Lunsumio in Relapsed or Refractory Follicular Lymphoma

In an interim analysis of the Phase III CELESTIMO study of patients with relapsed or refractory follicular lymphoma who had received at least two lines of therapy, treatment with Lunsumio in combination with lenalidomide demonstrated a statistically significant and clinically meaningful reduction in the risk of disease progression compared with the control regimen of Rituxan/MabThera (rituximab) plus lenalidomide These findings further support the potential of the Lunsumio and lenalidomide combination to improve clinical outcomes while maintaining a safety profile consistent with what has been previously observed and offering the convenience of a simple dosing schedule and a fixed treatment duration through the combination of Lunsumio (an injectable formulation) and lenalidomide (an oral medication) TOKYO, September 17, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Roche issued a media release today regarding data from the global Phase III CELESTIMO study in patients with relapsed or refractory follicular lymphoma. The global Phase III CELESTIMO study evaluated Lunsumio® for Intravenous Infusion 1 mg and 30 mg (generic name: mosunetuzumab [genetical recombination]) in combination with lenalidomide versus rituximab plus lenalidomide in patients with relapsed or refractory follicular lymphoma receiving second-line or later treatment. In an interim analysis, the study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with the Lunsumio plus lenalidomide combination. The safety profile of Lunsumio in combination with lenalidomide was consistent with the known safety profiles of the individual study medicines, and no new safety signals were identified. Detailed results from the CELESTIMO study are planned to be presented at an upcoming medical meeting. Please refer to the link below for details of the media release: Roche’s Lunsumio-based regimen significantly improves progression-free survival in follicular lymphoma in phase III CELESTIMO study https://www.roche.com/media/releases/med-cor-2026-09-17 Trademarks used or mentioned in this release are protected by law.

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