Genentech unveils pivotal neuroimmunology Phase III data at MSToronto2026

Key highlights
  • 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

chemXplore Weekly

The week’s project milestones and project news from the chemical industry, free every Wednesday.

Free. One email a week. Unsubscribe any time.

Related articles

30 September 2026
Roche’s fenebrutinib accepted for FDA priority review for RMS and PPMS

Phase III data showed ARR reductions of 51% and 58% vs teriflunomide and a numerical 12% reduction in PPMS progression versus ocrelizumab; CNS‑penetrant, non‑covalent BTK inhibitor.

1 March 2026
Genentech's Fenebrutinib Shows Promise as BTK Inhibitor for MS in Phase III Study

Fenebrutinib reduced relapses by 51% in RMS, consistent with prior studies. Data will be submitted to regulators. Safety profile comparable to teriflunomide; further analysis on fatalities ongoing.

15 October 2026
Genentech's Enspryng approved by FDA as first at‑home subcutaneous IL‑6R therapy for thyroid eye disease

FDA clears the first at‑home subcutaneous IL‑6R treatment for TED; Phase III SatraGO‑2 showed marked proptosis and diplopia improvements and safety consistent with prior NMOSD data.

10 September 2026
Roche: FDA grants Priority Review for Enspryng in MOGAD

FDA to decide by 10 Jan 2027 on satralizumab for MOGAD after Phase III METEOROID showed 68% relapse risk reduction; EMA validation pending EC decision in Q3 2027.

9 September 2026
Genentech: FDA grants Priority Review for Enspryng in MOGAD

Priority Review follows Phase III METEOROID showing 68% relapse risk reduction; FDA decision expected Jan 10, 2027; EMA validated the MOGAD filing with EC decision due Q3 2027.