Positive phase 3 results reported for twice yearly subcutaneous MS therapeutic
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Key takeaways:
- Ocrevus met primary and secondary endpoints in phase 3 OCARINA II clinical trial.
- Safety profile of 10-minute subcutaneous injection comparable with IV formulation.
Genentech announced positive results from its phase 3 OCARINA II clinical trial evaluating Ocrevus as a twice-a-year, 10-minute subcutaneous injection for those with relapsing forms of MS or primary progressive MS.
According to a company release, Ocrevus (ocrelizumab, Roche) met its primary and secondary endpoints of noninferiority in serum area under the curve from day 1 to 12 weeks after subcutaneous injection compared with IV infusion, as well as maximum serum concentration (Cmax) of Ocrevus; total number of active, gadolinium-enhancing T1 lesions at 8 and 12 weeks; and new or enlarging T2 lesions at 12 and 24 weeks.
Ocrevus subcutaneous injection was also comparable with Ocrevus IV in controlling MRI lesion activity in the brain over 12 weeks, while its safety profile was consistent with that of Ocrevus IV, the company added.
Per the release, Ocrevus 10-minute injection, designed without the customary infrastructure that IV administration requires, retains the twice-yearly dosing regimen of the IV formulation while providing an additional delivery option to simplify matching to needs of both patients and health care professionals.
“These results give people living with MS the possibility to receive the transformational benefits of Ocrevus in the way best suited to their lives while freeing up time and health care resources,” Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global Product Development, stated in the release. “This new subcutaneous injection will allow Ocrevus to be administered in 10 minutes twice a year, helping people living with MS to spend less time in treatment for this disease.’’
Detailed results from OCARINA II are expected to be presented at an upcoming medical meeting and submitted to global health authorities, Genentech added.