Genentech, a member of the Roche Group (RHHBY), reported positive data for Fenebrutinib, its investigational candidate from the Phase 3, FENhance 1 and 2 studies in relapsing multiple sclerosis or RMS, which met its primary endpoint. Meanwhile, an overall imbalance was observed in reported fatalities across studies.
Fenebrutinib is an investigational oral, central nervous system penetrant, reversible and non-covalent Bruton's tyrosine kinase inhibitor.
Trial Details
FENhance 1 and 2 are two Phase 3 multicenter, randomized, double-blind, double-dummy, parallel-group studies to evaluate the efficacy and safety of investigational fenebrutinib compared with teriflunomide in a total of 1,497 adult patients with RMS.
In the trial, participants were randomised 1:1 to receive either oral Fenebrutinib twice a day and placebo matched to oral teriflunomide once a day, or oral Teriflunomide once a day (and placebo matched to oral fenebrutinib twice a day) for at least 96 weeks.
Key Findings
The primary endpoint is annualised relapse rate (ARR), in which the studies showed that Fenebrutinib reduced the annualised relapse rate (ARR) by 51.1% in FENhance 1 and 58.5% in FENhance 2 compared with teriflunomide in patients with relapsing multiple sclerosis (RMS) over 96 weeks.
Secondary endpoints showed that Fenebrutinib significantly reduced disease activity in the brain, as evidenced by MRI scans. In addition, Fenebrutinib reduced markers of active inflammation by 70.7% in FENhance 1 and 77.6% in FENhance 2 compared with teriflunomide, as measured by new T1 gadolinium-enhancing (T1-Gd+) lesions.
Chronic disease burden was reduced by 76.0% FENhance 1 and 82.5% in FENhance 2 with Fenebrutinib compared with Teriflunomide, as measured by new or enlarging T2 lesions.
Additional secondary endpoints showed positive trends toward reducing disability progression with fenebrutinib. Also, the firm noted that infection rates were comparable between the Fenebrutinib and Teriflunomide arms.
Serious adverse events (AEs) were reported in 8.6% of patients receiving Fenebrutinib, compared with 8.9% on Teriflunomide in FENhance 1, and 11.2% compared with 6.1% in FENhance 2.
Meanwhile, the overall imbalance in reported fatalities was such that in FENhance 1 and 2, there was one death in the Teriflunomide arm and seven deaths in the Fenebrutinib arm during the reporting period.
The firm noted that the deaths occurred at different time points and were caused by various causes, including neuro cryptococcosis gattii and pneumonia infections.
The totality of data from all Phase III Fenebrutinib studies will be submitted to regulatory authorities.
The results were shared as a late-breaking presentation at the 2026 American Academy of Neurology (AAN) Annual Meeting in Chicago.
RHHBY has traded between $35.07 and $60.85 over the last year. The stock closed Tuesday's trade at $49.93, down 2.73%.
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