Genentech unveils pivotal neuroimmunology Phase III data at MSToronto2026
- Fenebrutinib reduced slowly expanding lesion volume up to 30% and paramagnetic rim lesion accumulation by 62% versus active comparators.
- In pooled RMS trials, 75% of fenebrutinib-treated patients achieved NEDA-3 and ARR was reduced by 55% over 96 weeks versus comparator.
- Ocrevus: 90% of children aged 10–17 remained relapse-free over two years in the OPERETTA 2 trial.
- Enspryng METEOROID analyses show reduced relapse risk and improved recovery in MOGAD; U.S. FDA decision expected January 2027.
Conference coverage
Genentech presented new Phase III data across more than 40 abstracts at MSToronto2026, including late-breaking fenebrutinib results and a "Best of MSToronto2026" Enspryng presentation.
Fenebrutinib pivotal Phase III findings
Pivotal trials in relapsing (FENhance 1 & 2) and primary progressive (FENtrepid) MS show fenebrutinib reduced slowly expanding lesion (SEL) volume up to 30% (RMS 96 weeks; PPMS 120 weeks) and decreased paramagnetic rim lesion (PRL) accumulation by 62% in RMS versus active comparators. In pooled RMS analyses, 75% of fenebrutinib-treated patients achieved no evidence of disease activity (NEDA-3), and annualized relapse rate (ARR) fell 55% over 96 weeks versus comparator. Additional findings include 23% lower annual total brain volume loss and a 16% reduction in 12-week composite confirmed disability progression.
Ocrevus across ages
OPERETTA 2 pediatric data show 90% of participants aged 10–17 remained relapse-free over two years. Analyses reported selective B‑cell depletion with preservation of other immune cells and maintained pre-existing vaccine immunity in most patients. In adults >55, 53% showed no disability progression at two years, similar to younger cohorts.
Enspryng in MOGAD
Exploratory METEOROID analyses indicate Enspryng reduced relapse risk and was associated with numerically superior recovery at 12 weeks post-relapse (median EDSS change -2 vs -0.5 versus placebo), supporting its potential in MOGAD; an FDA decision is expected in January 2027.
Source: Genentech