Roche’s fenebrutinib maintains near-complete suppression of disease activity and progression for up to two years in people with relapsing multiple sclerosis

Roche has recently announced their new 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis maintained no disability progression and low levels of disease activity for up to two years.

“These data show that patients treated with fenebrutinib experienced an annualised relapse rate equal to one relapse every 17 years and no observed disability progression up to two years,’’ said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Fenebrutinib is potent, highly selective and the only reversible BTK inhibitor currently in Phase III trials for multiple sclerosis, and we look forward to seeing the first of those results later this year.”

Note that ninety-nine patients entered the OLE and 93 remained in the OLE after 96 weeks. During the OLE period, patients treated with fenebrutinib for up to 96 weeks had a low annualised relapse rate of 0.06, and during this time there was no disability progression, as measured by the Expanded Disability Status Scale.

MRI scans showed that fenebrutinib treatment suppressed disease activity in the brain. At 96 weeks zero new T1 gadolinium-enhancing lesions, which are markers of active inflammation, were detected. In the treatment group that switched from placebo to fenebrutinib in the OLE, the annualised rate of new or enlarging T2 lesions, which represent chronic disease burden, decreased from 6.72 at the end of the 12 week double-blind period to 0.34 by 96 weeks.

Note that the safety profile of fenebrutinib in the OLE was consistent with previously reported data, with no new safety concerns identified at 96 weeks. The most common adverse events in ≥5% of patients were COVID-19, urinary tract infection, pharyngitis and respiratory tract infection. Serious AEs occurred in two patients. During the OLE, one patient experienced asymptomatic alanine aminotransferase elevation at OLE week 4, after 16 weeks on treatment, which resolved with treatment discontinuation.

 

---

---

Related Topics and Keywords

multiple sclerosis, relapsing multiple sclerosis, Roche, Roche’s fenebrutinib