Roche公布Lunsumio联合来那度胺III期CELESTIMO研究结果
Roche Announces Phase III CELESTIMO Study Results for Lunsumio in Relapsed or Refractory Follicular Lymphoma
Roche公布III期CELESTIMO研究中期分析结果：Lunsumio（mosunetuzumab）联合来那度胺在复发/难治性滤泡性淋巴瘤（≥2线治疗）中，较利妥昔单抗联合来那度胺显著改善PFS，达到主要终点。安全性与此前已知一致，未发现新信号，详细数据将在后续医学会议公布。
关注Lunsumio联合方案在二线及以上FL的PFS获益能否支持注册推进与适应症拓展。
- 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.
来源：Chugai 中外制药｜中外制药 · chugai-pharm.co.jp