Novartis on Friday presented detailed findings from the Phase III ASCLEPIOS I and II trials at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference, showing that ofatumumab reduced annualised relapse rates (ARR) by 50.5% and 58.5%, respectively, compared to Sanofi's Aubagio (teriflunomide), in patients with relapsing forms of multiple sclerosis (RMS). Last month, the Swiss drugmaker announced that both studies had achieved their primary endpoints.
Novartis' chief medical officer John Tsai commented "ofatumumab showed high efficacy and a favourable safety profile in people with RMS, offering a potential first B-cell therapy that can be self-administered in the home." Based on the findings, Novartis intends to pursue regulatory filings by the end of the year.
ASCLEPIOS I and II enrolled 1882 RMS patients with Expanded Disability Status Scale (EDSS) scores of 0 to 5.5 who were randomised to once-monthly subcutaneous injections with ofatumumab or once-daily oral Aubagio. The primary endpoint of both studies was reduction in frequency of confirmed relapses as evaluated by the ARR in patients treated up to 30 months. Secondary goals included time to disability progression confirmed at three and six months, confirmed disability improvement at six months, gadolinium enhancing T1 lesions, number of new or enlarging T2 lesions, serum levels of neurofilament light chain and rate of brain volume loss.
Novartis reported that the ARRs for the ofatumumab arms of the ASCLEPIOS I and II studies were 0.11 and 0.10, respectively, versus 0.22 and 0.25 for Aubagio. Ofatumumab also significantly suppressed both gadolinium T1 lesions and new or enlarging T2 lesions versus Aubagio, "demonstrating a profound suppression of new inflammatory activity," the company said. In addition, the treatment reduced the relative risk of three- and six-month confirmed disability progression by 34.4% and 32.5%, respectively, compared to Aubagio in pre-specified pooled analyses. Novartis noted that the safety profile of ofatumumab was consistent with previous observations in mid-stage testing.
Novartis gained rights to ofatumumab for oncology indications via its 2015 asset swap with GlaxoSmithKline, with the Swiss drugmaker later purchasing rights to the drug in all other indications in a deal potentially worth more than $1 billion.
"These further support our firm belief in the potential of subcutaneous ofatumumab to provide an excellent and very convenient option to profoundly improve the lives of patients living with RMS," remarked Jan van de Winkel, CEO of Genmab, which co-developed the drug with GlaxoSmithKline.
Ofatumumab has been authorised in the US and EU for the first-line treatment of chronic lymphocytic leukaemia (CLL) under the name Arzerra. The treatment was later approved by the FDA and European Commission for patients with relapsed CLL.
For related analysis, see Physician Views snap poll results: If efficacy data are compelling, Novartis' ofatumumab should provide a tangible threat to Roche's Ocrevus, and ViewPoints: Novartis sets up key data unveiling at ECTRIMS for Ocrevus competitor.
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