Roche's BTK Inhibitor Fenebrutinib Shows Promise in Phase 3 Multiple Sclerosis Trials

Roche has reported significant wins for its Bruton's tyrosine kinase (BTK) inhibitor fenebrutinib in two phase 3 multiple sclerosis (MS) trials, marking a potential breakthrough in a field where competitors have struggled. The Swiss pharmaceutical giant's success comes at a time when other major players have faced setbacks in their BTK inhibitor programs for MS.

Fenebrutinib Demonstrates Efficacy in Relapsing MS

In the Fenhance trial, fenebrutinib showed a significant reduction in annualized relapse rate compared to Sanofi's Aubagio over at least 96 weeks of treatment in patients with relapsing MS. This achievement met the trial's primary endpoint, positioning fenebrutinib as a potential new option for patients with this form of the disease.

Non-Inferiority to Ocrevus in Primary Progressive MS

The Fentrepid trial, focusing on primary progressive MS (PPMS), demonstrated that fenebrutinib was non-inferior to Roche's own anti-CD20 antibody Ocrevus in delaying the onset of composite confirmed disability progression over at least 120 weeks of therapy. Notably, fenebrutinib showed numerically better performance than Ocrevus starting at Week 24, maintaining this edge throughout the observation period.

Safety Profile and Regulatory Outlook

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 at upcoming medical meetings and will consider regulatory submissions once data from a second Fenhance study becomes available in the first half of next year.

Competitive Landscape in BTK Inhibition for MS

Roche's success with fenebrutinib stands out in a field where other pharmaceutical companies have faced challenges:

• Sanofi's tolebrutinib is under FDA review, but has experienced delays and missed primary endpoints in relapsing MS trials.
• Merck KGaA discontinued its BTK inhibitor evobrutinib after failing to outperform Aubagio in relapsing MS studies.
• Biogen exited the BTK race in 2023, with Zenas BioPharma subsequently acquiring rights to their candidate.
• Novartis continues phase 3 development of its own BTK inhibitor for relapsing and secondary progressive MS.

As the multiple sclerosis treatment landscape evolves, Roche's fenebrutinib emerges as a promising contender, potentially offering new hope for patients across different forms of the disease. The pharmaceutical industry will be closely watching the upcoming full data release and regulatory decisions, which could reshape the MS treatment paradigm.