Novartis’ new data demonstrates superiority in MS treatment

Novartis presented positive results of the Phase III ASCLEPIOS I and II studies at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, Sweden.

Data from both studies show ofatumumab (OMB157), a fully human anti-CD20 monoclonal antibody (mAb), was superior to Sanofi’s Aubagio (teriflunomide) in patients with relapsing forms of MS (RMS). The ASCLEPIOS I and II studies are twin, identical design, flexible duration (up to 30 months), double-blind, randomised, multi-center Phase III studies evaluating the safety and efficacy of ofatumumab 20mg monthly subcutaneous injections versus Aubagio 14mg oral tablets taken once daily in adults with RMS.

Both studies met the primary endpoints where ofatumumab showed a highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as the annualised relapse rate (ARR). Patients treated with ofatumumab had an ARR of 0.11 and 0.10 compared to Aubagio (ARR of 0.22 and 0.25) in ASCLEPIOS I and II respectively, corresponding to a reduction in ARR by 50.5% and 58.8% with ofatumumab (p<0.001 in both studies).

Ofatumumab showed highly significant suppression of both Gd+ T1 lesions and new or enlarging T2 lesions compared to Aubagio, demonstrating a profound suppression of new inflammatory activity. Additionally, ofatumumab showed a relative risk reduction of 34.4% (p=0.002) in 3-month confirmed disability progression (CDP†) and 32.5% (p=0.012) in 6-month CDP versus Aubagio in pre-specified pooled analyses[1]. Overall ofatumumab, a potent, fully-human antibody targeting CD20 positive B-cells, delivered efficacy with a favourable safety profile. The safety profile of ofatumumab as seen in the ASCLEPIOS studies is in line with the observations from Phase II results.

Novartis plans to initiate submissions to health authorities by end of 2019.

“It is clear that early initiation of highly effective treatment for MS improves long-term outcomes, and there is great need for potent, safe, and convenient therapy that can be used to treat MS from the start,” said Professor Stephen L. Hauser, Director of the UCSF Weill Institute for Neurosciences. “The results from ASCLEPIOS are wonderful news for patients who would like to take an extremely effective B-cell therapy with low requirement for monitoring, avoiding visits to an infusion center.”

“Ofatumumab showed high efficacy and a favorable safety profile in people with RMS, offering a potential first B-cell therapy that can be self-administered in the home,” said John Tsai, Head of Global Drug Development and Chief Medical Officer, Novartis. “This is a big step forward in our relentless efforts to advance and reimagine treatment in the MS journey of each patient.”

Under the brand name Arzerra, ofatumumab is an approved infusion treatment for adults with chronic lymphocytic leukemia, a blood cancer that typically develops in B-cells. Novartis acquired the rights to develop and commercialise ofatumumab under a license from Genmab.