Data For Mayzent, Kesimpta Released at MSVirtual 2020

September 11, 2020

Data presented on a pair of Novartis MS therapies during MSVirtual2020.

Post-hoc data for a pair of Novartis multiple sclerosis (MS) therapies showed the ability of treatments to address the need for patients who are newly diagnosed with the disease and those with secondary progressive MS (SPMS).

The data were presented during MSVirtual 2020, convening online today through Sunday as the 8th joint meeting of ACTRIMS-ECTRIMS, which happens when the Americas and European Committees for Treatment and Research in Multiple Sclerosis gather for a joint meeting. Novartis announced the data in statements released Friday.

Kesimpta
New post-hoc data for Kesimpta (ofatumumab), a targeted B-cell therapy, show the treatment’s safety and efficacy as a first-line treatment for patients newly diagnosed with relapsing forms of MS. “These encouraging data show that newly diagnosed and treatment-naïve patients may benefit from lower disease activity when treated with Kesimpta,” said Amit Bar-Or, MD, FRCP, FAAN, FANA, University of Pennsylvania.

FDA approved a self-administered version of the drug, to be given once a month through an autoinjector pen, based on phase 3 results of the ASCLEPIOS I and II trials. Those trials randomly assigned 946 patients to receive the study drug, ofatumumab, and 936 to receive teriflunomide.

Friday's post-hoc analysis included a subgroup of 615 patients with early RMS (newly diagnosed and treatment-naïve) from the ASCLEPIOS trials. The findings show that Kesimpta significantly reduced the annualized relapse rate (ARR) by 50.3% compared with teriflunomide.

Safety data from the phase 3b ALITHIOS trial reported that patients who continued on Kesimpta from the ASCLEPIOS trials or the phase 2 APLIOS trial or switched from the teriflunomide in the ASCLEPIOS trial showed no new safety signals, highlighting the safety of Kesimpta in patients with relapsing MS (RMS).

“Collectively, these data add to the body of evidence that shows Kesimpta to be a powerful B-cell therapy with a favorable safety profile for people living with RMS, including those who are newly diagnosed or previously treated,” said Krishnan Ramanathan, Neuroscience Global Program Head at Novartis. “Novartis is committed to reimagining care and bringing innovative treatment options for people living with this disease.”

Mayzent
Additional data presented Friday during the virtual meeting show early treatment with Mayzent (siponimod) delays progression and offers benefits in cognitive performance in patients with secondary progressive multiple sclerosis (SPMS).

“One of the biggest goals for people living with MS is to be able to live their lives independently for as long as possible," said Norman Putzki, MD, global head of Development, Neuroscience. “The data presented (Friday) reinforces that through its beneficial effects on cognitive performance and delaying disability progression, and as an appropriate option for patients to safely switch to/from other treatments, Mayzent offers hope for people looking to achieve this important goal.”

The EXPAND study is a randomized, double-blind, placebo-controlled phase 3 study, comparing the efficacy and safety of Mayzent versus placebo in patients with SPMS with varying levels of disability. It enrolled 1,651 patients who were randomized 2:1 to take 2 mg of Mayzent once a day or placebo. Patients were evaluated every 3 months and when relapses occurred; an MRI took place at screening and at 12 months.

A post hoc EXPAND analysis found that in patients with active disease, an increased chance for clinically relevant improvement was observed and patients with active SPMS early and continuously treated with Mayzent experienced lower risk of disability progression and cognitive decline than patients who delayed Mayzent treatment. Post-hoc data also showed patients taking Mayzent saw improvements in cognitive processing speed, whether their SPMS was active or non-active, and these benefits could last as long as five years. Mayzent was safe and well-tolerated even when patients switched from an oral or injectable disease-modifying therapy.