Ofatumumab Demonstrates Superiority Versus Teriflunomide in Two Head-to-Head Phase III Multiple Sclerosis Studies
Company Announcement
In ASCLEPIOS I and II, ofatumumab (OMB157) met primary endpoints to reduce the annualized relapse rate (ARR) over teriflunomide in patients with relapsing forms of multiple sclerosis (RMS)
Key secondary endpoints of delaying time to confirmed disability progression were also met
Ofatumumab delivered sustained efficacy with a safety profile in line with observations from prior Phase II results
Novartis plans to initiate submissions to health authorities by end of 2019
Copenhagen, Denmark; August 30, 2019 – Genmab A/S (Nasdaq: GMAB) announced today that its partner for ofatumumab, Novartis, reported positive results for ofatumumab (OMB157) from the Phase III ASCLEPIOS I and II studies. The ASCLEPIOS studies, which investigated the efficacy and safety of monthly subcutaneous ofatumumab 20mg versus once daily oral teriflunomide 14mg in adults with relapsing forms of multiple sclerosis (RMS), met the primary endpoints where ofatumumab showed a highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as the annualized relapse rate (ARR). Key secondary endpoints of delaying the time to confirmed disability progression were also met. According to Novartis, ofatumumab delivered sustained efficacy and the safety profile of ofatumumab as seen in the ASCLEPIOS studies is in line with the observations from prior Phase II results.
“This data signifies a possible turning point for ofatumumab and provides support for our belief that it has the potential, if approved, to become the first subcutaneous B-cell therapy for relapsing MS that can be self-administered by patients at home. We look forward to feedback from regulatory authorities and to this exciting next phase in ofatumumab’s development,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Based on the ASCLEPIOS data, Novartis, which has the rights to develop and commercialize ofatumumab under a license from Genmab, plans to initiate submissions to health authorities by end of 2019.
Results of the Phase III ASCLEPIOS studies will be presented as a late-breaker presentation on September 13 at the prestigious 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place September 11–13, 2019, in Stockholm, Sweden.