Fenebrutinib numerically reduced the risk of disability progression by 12% compared to Ocrevus as early as 24 weeks; additional analysis showed potential benefit in upper limb function
Genentech, part of the Roche Group, has released new late-breaking results from the Phase III FENtrepid study showing that its investigational Bruton’s tyrosine kinase inhibitor fenebrutinib met the primary endpoint of non-inferiority compared with Ocrevus in reducing disability progression in patients with primary progressive multiple sclerosis. Fenebrutinib reduced the risk of 12-week composite confirmed disability progression by 12 percent compared with Ocrevus with benefits visible as early as 24 weeks. The study measured disability using a composite endpoint that includes the Expanded Disability Status Scale for overall functional ability, the timed 25-foot walk for mobility, and the nine-hole peg test for upper limb function, with the strongest effect observed in upper limb performance, reducing risk by 26 percent.
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Professor Amit Bar-Or, Director of the Center for Neuroinflammation and Neurotherapeutics at the Perelman School of Medicine, University of Pennsylvania, noted that fenebrutinib showed consistent clinical benefit starting at week 24, particularly in preserving upper limb function, which is essential for independence in daily activities. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Genentech, added that fenebrutinib represents the first significant potential advancement for the PPMS community in over ten years and showed meaningful benefit compared with the only approved therapy for the disease. Genentech plans to advance regulatory submissions after the readout of the second pivotal RMS study, FENhance 1.
A post-hoc analysis indicated that fenebrutinib was superior to Ocrevus on a composite endpoint that included two of the three disability measures, showing a 22 percent reduction in risk. The safety profile was generally comparable to Ocrevus. Common adverse events in the fenebrutinib group included infections, nausea, and hemorrhage, with reversible liver enzyme elevations observed more frequently in the fenebrutinib arm. Serious adverse events occurred in 19.1 percent of patients on fenebrutinib versus 18.9 percent on Ocrevus. Fatal events were rare, occurring in 1.4 percent of fenebrutinib patients and 0.2 percent of Ocrevus patients, with investigators assessing them as unrelated to treatment.
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The FENtrepid study is a Phase III, randomized, double-blind, double-dummy trial including 985 adult patients with PPMS. Participants were assigned to receive either daily oral fenebrutinib with a placebo IV infusion or IV Ocrevus with a placebo oral tablet for at least 120 weeks. The study’s primary endpoint is time to onset of 12-week composite confirmed disability progression. The composite captures multiple aspects of disability and is more sensitive than the EDSS alone. Key secondary endpoints include 24-week composite confirmed disability progression and 12- and 24-week confirmed disability progression measures. After completing the double-blind period, participants may continue in an open-label extension receiving fenebrutinib.
This study highlights fenebrutinib as a promising oral therapy for PPMS with potential to improve functional outcomes and provide a new treatment option for patients facing a progressive disease with limited approved therapies.
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