Roche’s High-Dose Ocrevus Trial Fails to Show Added MS Benefit

Roche’s Phase III Musette trial evaluating higher doses of Ocrevus (ocrelizumab) in relapsing multiple sclerosis (MS) patients has failed to meet its primary endpoint. The study found that while 1,200mg and 1,800mg doses were well tolerated, they showed no greater impact on slowing disability progression than the approved 600mg dose. Conducted at 122 international sites with 864 participants, the trial assessed time to 12-week composite confirmed disability progression using measures like the EDSS scale. Despite the setback, Roche highlighted that Ocrevus maintained low progression and relapse rates consistent with prior studies, with one relapse every 16 years—marking the lowest annualized relapse rate (ARR) seen in a Phase III MS trial. Ocrevus remains the only B-cell therapy approved for both relapsing and primary progressive MS. Roche, whose drug earned $7.5 billion in 2024, expects continued growth after FDA approval of a subcutaneous version in September 2024.

07-04-2025

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