Roche Reports Phase 3 Success for BTK Inhibitor in Multiple Sclerosis Trials
Roche has announced positive results from two phase 3 clinical trials evaluating its Bruton's tyrosine kinase (BTK) inhibitor, fenebrutinib, in multiple sclerosis (MS) patients. The studies, Fenhance and Fentrepid, demonstrated the drug's efficacy in both relapsing MS and primary progressive MS (PPMS) populations, potentially positioning Roche as a leader in the competitive BTK inhibitor landscape.
Fenhance Trial: Fenebrutinib Outperforms Aubagio in Relapsing MS
In the Fenhance study, fenebrutinib showed a significant reduction in annualized relapse rate compared to Sanofi's Aubagio over at least 96 weeks of treatment. This outcome met the trial's primary endpoint, marking a crucial win for Roche in the relapsing MS market. The company plans to consider these data, along with results from a second ongoing Fenhance study due in the first half of next year, for submission to regulatory authorities.
Fentrepid Trial: Non-inferiority to Ocrevus in PPMS
The Fentrepid trial, focusing on PPMS patients, demonstrated fenebrutinib's non-inferiority to Roche's own anti-CD20 antibody, Ocrevus – currently the only approved treatment for PPMS. The study measured the delay in the onset of composite confirmed disability progression over at least 120 weeks of therapy. Notably, fenebrutinib showed numerically better performance than Ocrevus starting from Week 24, maintaining this edge throughout the observation period.
Safety Profile and Industry Landscape
Roche reported that the liver safety profile of fenebrutinib was consistent with previous studies, addressing a key concern associated with BTK inhibitors. The company plans to share full results, including additional safety data, at upcoming medical meetings.
These positive outcomes for fenebrutinib come at a time when several pharmaceutical companies have faced setbacks in their BTK inhibitor programs. Sanofi's tolebrutinib is under FDA review but has experienced delays and missed endpoints in relapsing MS trials. Merck KGaA recently discontinued its BTK inhibitor evobrutinib after failing to outperform Aubagio in relapsing MS studies. Biogen exited the BTK race in 2023, while Novartis continues phase 3 development of its candidate in relapsing and secondary progressive MS.
References
- Roche reports phase 3 multiple sclerosis wins for BTK inhibitor, succeeding where rivals failed
Roche has reported wins for its BTK inhibitor fenebrutinib in a pair of phase 3 multiple sclerosis trials. One victory was based on the finding that the candidate was non-inferior to Ocrevus, despite the company originally designing the study to show superiority to the incumbent MS treatment.
Explore Further
What factors might contribute to fenebrutinib's potential industry leadership among BTK inhibitors for multiple sclerosis?
What are the reported differences in safety profiles between fenebrutinib and other BTK inhibitors currently in development or on the market?
How does the efficacy of fenebrutinib in PPMS compare to Ocrevus over extended treatment periods, as suggested by the trial data?
What challenges have other pharmaceutical companies faced in developing BTK inhibitors for relapsing MS, and how has Roche addressed similar obstacles?
What is the projected market impact of fenebrutinib if approved for both relapsing MS and PPMS?