Roche says MUSETTE trial did not meet primary endpoint

Genentech, a member of the Roche (RHHBY) Group, announced that the Phase 3 MUSETTE trial comparing a high dose of Ocrevus intravenous infusion to the currently approved Ocrevus IV 600 mg dose in people with relapsing multiple sclerosis did not meet its primary endpoint in showing additional benefit in slowing disability progression, as measured by a composite disability endpoint over a period of at least 120 weeks of treatment. The rates of disability progression were low and consistent with rates observed in the previous pivotal studies of Ocrevus IV 600 mg. In addition, in several predefined analyses on disease activity, Ocrevus IV 600 mg showed clinically meaningful results with the lowest annualized relapse rate observed during the double-blind period of a Phase III study in RMS, the company stated. “The MUSETTE data further support the efficacy and safety profile of the currently approved Ocrevus IV 600 mg dose for RMS,” Roche added. Levi Garraway, M.D., Ph.D., Genentech’s Chief Medical Officer and head of Global Product Development, said: “Ocrevus is the first and only B-cell therapy approved for RMS and PPMS and after more than ten years of treatment, the majority of people with RMS remain free from disease progression. These findings reaffirm that the current Ocrevus IV 600 mg is optimally dosed to significantly slow disability progression. Moreover, in several predefined analyses on disease activity, Ocrevus showed clinically meaningful results on relapses with a relapse occurring approximately once every 16 years, a first for an anti-CD20 RMS medicine.”