刚刚！罗氏新药III期成功，但8例死亡病例引发关注

Core Insights - Roche announced that its oral BTK inhibitor Fenebrutinib achieved the primary endpoint in the pivotal Phase III study (FENhance 1) for relapsing multiple sclerosis (RMS) [1][6] - This marks the completion of all three pivotal Phase III studies for Fenebrutinib in the multiple sclerosis (MS) field [2][8] Efficacy Results - The FENhance 1 study demonstrated a significant reduction in annualized relapse rate (ARR) by 51% compared to the active control drug teriflunomide over a treatment period of at least 96 weeks, consistent with the results from the previously published FENhance 2 study, which showed a 59% reduction in ARR [3][9] - Combined data from both studies indicate that patients treated with Fenebrutinib experience a relapse on average every 17 years, showcasing strong disease control capabilities [4][10] Secondary Endpoints and Safety - Both RMS studies showed statistically significant and clinically meaningful effects of Fenebrutinib in reducing brain lesions (MRI lesions) [4][10] - All disease progression-related endpoints, including the composite confirmed disability progression at 12 and 24 weeks (cCDP), indicated favorable trends for Fenebrutinib [4][10] - The overall tolerability of Fenebrutinib was good, with liver enzyme elevations comparable to the control drug teriflunomide, and only one case of asymptomatic and reversible Hy's Law observed in each treatment group [4][10] - Notably, there were 8 deaths of various causes reported in the Fenebrutinib group across the two RMS studies, compared to 1 in the control group, prompting further investigation by Roche to clarify the reasons [4][10] Drug Profile and Future Plans - Fenebrutinib is a non-covalent, reversible, and highly selective BTK inhibitor designed to target both the peripheral and central nervous systems, addressing both acute inflammation and chronic damage driving long-term disability progression [5][11] - Roche's Chief Medical Officer, Dr. Levi Garraway, stated that the key study results, combined with early data, provide strong evidence that Fenebrutinib could become the first high-efficacy oral therapy for both relapsing (RMS) and primary progressive multiple sclerosis (PPMS) [5][11] - Roche plans to present the complete data from the FENhance 1, FENhance 2, and FENtrepid studies at the 2026 American Academy of Neurology (AAN) annual meeting and submit it to regulatory authorities [5][11]