Roche’s High-Dose Ocrevus Trial Misses Target, Reinforcing Standard Dose for MS Treatment” ###
Trial Outcome:
The Phase III MUSETTE trial testing high-dose intravenous Ocrevus failed to demonstrate additional benefits in slowing disability progression in relapsing multiple sclerosis (RMS) compared to the standard 600 mg dose245.
Efficacy of Standard Dose:
The currently approved 600 mg dose of Ocrevus continues to show low rates of disability progression and boasts the lowest annualized relapse rate (ARR) observed in a Phase III RMS study25.
Safety Profile:
Both the high-dose and standard dose were well tolerated, with no new safety concerns reported during the MUSETTE trial45.
Market Position:
Ocrevus remains the most prescribed disease-modifying therapy for MS globally, treating over 400,000 patients to date. It has set a new standard of care in MS treatment248.
Expansion of Options:
Roche recently introduced a subcutaneous formulation of Ocrevus, which offers comparable efficacy to intravenous administration and is designed for increased convenience and accessibility146.
Future Focus:
Roche is investing in new forms of Ocrevus delivery, such as a high-concentration formulation for on-body devices, while also exploring innovative treatments for neurological disorders beyond MS28.
Sources:
1. https://www.clinicaltrialsarena.com/news/roche-multiple-sclerosis-trial/
2. https://www.roche.com/investors/updates/inv-update-2025-04-02b
4. https://www.neurologylive.com/view/genentech-reports-high-dose-ocrelizumab-failed-show-additional-benefit-relapsing-ms
5. https://www.clinicaltrialsarena.com/news/roches-high-dose-ocrevus-fails-primary-endpoint-in-ms-trial/
6. https://www.roche.com/media/releases/med-cor-2023-07-13
8. https://www.stocktitan.net/news/RHHBY/roche-provides-update-on-phase-iii-ocrevus-high-dose-study-in-people-nq8xb96ymba4.html