Novartis announced Friday that ofatumumab met the primary endpoints of the Phase III ASCLEPIOS I and II trials, reducing annualised relapse rates compared to Sanofi's Aubagio (teriflunomide) in patients with relapsing forms of multiple sclerosis (MS). Novartis added that ofatumumab, a fully human antibody targeting CD20-positive B-cells, also met key secondary endpoints of delaying time to confirmed disability progression.
In the two head-to-head studies, a combined 1882 patients with relapsing forms of MS were randomised to treatment with once-monthly subcutaneous injections of ofatumumab or once-daily oral Aubagio. The primary endpoint of both trials was the annualised relapse rate in patients treated up to 30 months. Secondary endpoints included time to disability progression examined at three months and six months, disability improvement at six months, gadolinium enhancing T1 lesions, number of new or enlarging T2 lesions and rate of brain volume loss.
Novartis noted that the safety profile of ofatumumab was consistent with the findings in mid-stage trials. Top-line results of the ASCLEPIOS studies will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congress in September. The Swiss drugmaker added that it will initiate regulatory submissions of the therapy in relapsing MS by the end of this year.
Novartis acquired rights to ofatumumab for oncology indications as part of an asset swap  with GlaxoSmithKline in 2015. The Swiss drugmaker later purchased  the rights to the treatment for all other indications in a separate deal valued at potentially more than $1 billion. The drug was approved in the US  and Europe  in 2014 for the first-line treatment of chronic lymphocytic leukaemia (CLL) in patients who are not suitable for fludarabine-based therapy. The drug, which is marketed as Arzerra, has since also been cleared for use in combination with fludarabine and cyclophosphamide in relapsed CLL in both the US  and Europe .
Novartis chief medical officer John Tsai suggested that ofatumumab "could be a highly attractive treatment option for a broad [relapsing MS] patient population, including early MS." Meanwhile, Jan van de Winkel, chief executive at Genmab, which co-developed  the drug with GlaxoSmithKline, said "this data signifies a possible turning point for Arzerra 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."
Ofatumumab works similarly to Roche's MS therapy Ocrevus (ocrelizumab), targeting the immune system's B cells, with Zuercher Kantonalbank analyst Michael Nawrath saying "it would have been better to see a direct comparison between two MS drugs with the same mechanism of action." He added "as it stands, we'll only be able to make an indirect comparison of the data to predict whether the Novartis drug will be a threat to the market leader and, at this time, the best MS medicine, Ocrevus." Roche's drug generated  sales of CHF 1.7 billion ($1.7 billion) in the first half of this year.
Meanwhile, Bill Anderson, who heads Roche's Genentech unit, remarked that other companies' attempts to move in on the MS drugs market has only boosted its own sales, helping it to capture a 17% market share. According to Anderson, since the launch of Novartis' S1P receptor modulator Mayzent  (siponimod) in March for relapsing forms of MS, Ocrevus has actually gained market share.
For related analysis, see ViewPoints: Novartis sets up key data unveiling at ECTRIMS for Ocrevus competitor .