Genentech Presents New Pivotal Trial Data Across Broad Neuroimmunology Portfolio at MSToronto2026
Fenebrutinib FENtrepid and FENhance 1 & 2 late-breaking data demonstrate a therapeutic effect on chronic active lesions, addressing a primary driver of long-term disability progression in multiple sclerosis (MS)
Fenebrutinib FENhance 1 & 2 Phase III pooled data show a 55% reduction in annualized relapse rate (ARR) vs active comparator
Ocrevus OPERETTA 2 Phase III data show 90% of children aged 10–17 remained relapse-free over two years, reinforcing consistent MS control across all ages
Featured in "Best of MSToronto2026," Enspryng METEOROID Phase III data highlight significant attack reduction and improved functional recovery in MOGAD, an underserved autoimmune disease
SOUTH SAN FRANCISCO, Calif., October 21, 2026--Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today new Phase III data for investigational fenebrutinib in multiple sclerosis (MS), demonstrating reduced markers of chronic brain inflammation as well as more comprehensive disease control versus active comparators. These findings, alongside new Ocrevus® (ocrelizumab) and Enspryng® (satralizumab) data, will be featured across more than 40 abstracts at MSToronto2026 (10th ACTRIMS-ECTRIMS Meeting), held October 21 to 23 in Toronto. Highlights include a fenebrutinib late-breaking presentation and an Enspryng presentation in the "Best of MSToronto2026."
"Addressing long-term disability progression to preserve people's independence remains a critical challenge in neuroinflammatory diseases, and particularly in multiple sclerosis," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Our recent data indicate that fenebrutinib can inhibit disease activity inside and outside the central nervous system, underscoring its potential to transform care for people living with relapsing and primary progressive forms of multiple sclerosis."
Fenebrutinib targets progressive biology inside the brain
New data from the pivotal trials in RMS (FENhance 1 and 2) and PPMS (FENtrepid) support the potential of fenebrutinib as the first and only high-efficacy oral medicine for both forms of MS.
Reduction of chronic active lesions (Late-breaking oral #O137): In the first prospective demonstration of a therapeutic effect on chronic active lesions in MS Phase III clinical trials, data show fenebrutinib reduced the volume of slowly expanding lesions (SELs) by up to 30% (p<0.001) in RMS (over 96 weeks) and PPMS (over 120 weeks), along with a 62% (p=0.001) reduction in accumulation of paramagnetic rim lesions (PRLs) in RMS, versus active comparators. These findings demonstrate that fenebrutinib directly targets chronic neuroinflammation in the brain, a primary driver of disability progression in MS.
Comprehensive disease control (Poster #P1434): In the pooled RMS trials, three quarters (75%) of fenebrutinib-treated patients showed no evidence of disease activity (NEDA-3) meaning zero relapses, zero MRI activity and zero worsening disability at nearly two years, a 70% reduction (p<0.001) versus the comparator. These results show fenebrutinib's potential to suppress disease activity and delay progression.
Preserving brain volume and function (Oral #O089): Pooled RMS data show fenebrutinib reduced the annualized relapse rate (ARR) by 55% versus the comparator (p<0.001) over 96 weeks. In addition, fenebrutinib reduced annual total brain volume loss by 23% (p<0.001) and 12-week composite confirmed disability progression by 16% (p=0.04). These findings demonstrate fenebrutinib's potential to control relapses, to slow brain tissue loss caused by neuronal cell death and to preserve function.