{"id":46348,"date":"2025-11-11T13:33:48","date_gmt":"2025-11-11T05:33:48","guid":{"rendered":"https:\/\/flcube.com\/?p=46348"},"modified":"2025-11-11T13:33:49","modified_gmt":"2025-11-11T05:33:49","slug":"roche-announces-positive-phase-iii-results-for-fenebrutinib-in-relapsing-primary%e2%80%91progressive-multiple-sclerosis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=46348","title":{"rendered":"Roche Announces Positive Phase\u202fIII Results for Fenebrutinib in Relapsing & Primary\u2011Progressive Multiple Sclerosis"},"content":{"rendered":"\n

Roche Holding AG<\/strong> (SWX: ROG<\/a>, OTCMKTS: RHHBY<\/a>) reported that both pivotal Phase\u202fIII trials of its oral Bruton\u2019s tyrosine\u2011kinase (BTK) inhibitor fenebrutinib<\/strong> have met their primary endpoints in two distinct forms of multiple sclerosis (MS)<\/strong>.<\/p>\n\n\n\n

Trial 1 \u2013 FENhance\u202f2 (Relapsing MS)<\/h2>\n\n\n\n
Parameter<\/th>Detail<\/th><\/tr><\/thead>
Study Design<\/strong><\/td>Randomised, double\u2011blind, active\u2011comparator (teriflunomide)<\/td><\/tr>
Population<\/strong><\/td>Patients with relapsing\u2011remitting MS (RMS)<\/td><\/tr>
Duration<\/strong><\/td>\u2265\u202f96\u202fweeks of continuous treatment<\/td><\/tr>
Primary Endpoint<\/strong><\/td>Annualised Relapse Rate (ARR) reduction<\/td><\/tr>
Result<\/strong><\/td>Statistically significant ARR reduction<\/strong> vs. teriflunomide (p\u202f<\u202f0.001)<\/td><\/tr>
Safety<\/strong><\/td>Liver\u2011enzyme profile consistent with earlier fenebrutinib data; no new safety signals identified<\/td><\/tr>
Status<\/strong><\/td>Data under further safety review; submission to regulatory agencies planned for 2026<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Trial 2 \u2013 FENtrepid (Primary\u2011Progressive MS)<\/h2>\n\n\n\n
Parameter<\/th>Detail<\/th><\/tr><\/thead>
Study Design<\/strong><\/td>Randomised, double\u2011blind, active\u2011comparator (ocrelizumab \u2013 OCREVUS)<\/td><\/tr>
Population<\/strong><\/td>Patients with primary\u2011progressive MS (PPMS)<\/td><\/tr>
Duration<\/strong><\/td>\u2265\u202f120\u202fweeks of treatment<\/td><\/tr>
Primary Endpoint<\/strong><\/td>Time to composite confirmed disability progression (CDP)<\/td><\/tr>
Result<\/strong><\/td>Non\u2011inferior<\/strong> to ocrelizumab; early numerical advantage for fenebrutinib observed at week\u202f24 and sustained through week\u202f120<\/td><\/tr>
Safety<\/strong><\/td>Comparable adverse\u2011event profile to ocrelizumab; no increase in serious infections or hepatic events<\/td><\/tr>
Implication<\/strong><\/td>First oral BTK inhibitor to demonstrate parity with the only approved PPMS therapy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Fenebrutinib \u2013 Mechanistic & Commercial Outlook<\/h2>\n\n\n\n