Novartis Says New Mayzent Data Shows Sustained Effect In Delaying Disability

Novartis announced new Mayzent (siponimod) data in the April supplemental issue of Neurology, the medical journal of the American Academy of Neurology. The data build on existing clinical evidence that Mayzent has proven to slow physical disability progression and provide cognitive benefits in people living with secondary progressive multiple sclerosis (SPMS). Although every patient’s multiple sclerosis (MS) journey is unique, 1 in 4 relapsing-remitting MS (RRMS) patients on treatment transition to SPMS within 10 years of RRMS onset.

Data released from the five-year EXPAND open-label extension trial assessed the long-term efficacy and safety of Mayzent in patients with SPMS who on entering the extension trial either continued on Mayzent treatment (Mayzent group) or switched from placebo to Mayzent (placebo switch group). Patients in the Mayzent group were significantly less likely to experience both three- and six-month confirmed disability progression (CDP) (p=0.0064 and p=0.0048, respectively) compared with the placebo switch group, which underscores advantages of early treatment initiation. These data were included in the April supplemental issue of Neurology after the 2020 American Academy of Neurology Annual Meeting was cancelled due to COVID-19.

“The data continue to show that Mayzent has the ability to help patients maintain independence for longer through its long-term effect on delaying progression and cognitive impairment,” said Norman Putzki, MD, Global Head of Development Neuroscience. “Novartis is committed to reimagining medicine for patients with progressive diseases and with Mayzent, Novartis offers patients hope for improved health outcomes.”

The new data also show a 52% reduction in the annualized relapse rate (ARR) observed in the Mayzent group compared to the placebo switch group (p<0.0001). Risk of confirmed worsening of cognitive impairment (according to the Symbol Digit Modalities Test) at six-months was reduced by 23% for the Mayzent group compared with placebo switch group (p=0.0014). The benefits seen in the Mayzent group were sustained for up to five years, underscoring the advantages of early treatment initiation with Mayzent. The incidence of adverse events was consistent with the controlled treatment period. This EXPAND open-label extension is ongoing for up to a total of seven years.

Additional Mayzent data shared in the same Neurology issue includes a new post-hoc analysis from EXPAND, which showed Mayzent consistently reduced cortical grey matter (cGM) and thalamic atrophy in patients with SPMS, including those with less active and more advanced disease. Across the subgroups studied, Mayzent reduced cGM atrophy versus placebo by 48–116% (p<0.01 at both M12 and M24) and thalamic atrophy by 30– 68% (p<0.05 at both M12 and M24; except for ‘disease duration >15 years’ p=0.1029 at M12) Combined with other analyses, these findings could translate into a favorable impact on long-term clinical outcomes including disability progression and cognitive decline.

Further analysis from EXPAND, evaluating Mayzent’s effect on magnetization transfer ratio (MTR) changes in patients with SPMS, builds on existing pre-clinical evidence that suggests Mayzent may promote repair mechanisms in the central nervous system (CNS). MTR is a technique widely used for estimating myelin content in the brain. MTR results show that Mayzent significantly reduces de-myelination and substantiate previous pre-clinical findings on remyelination.

“These data highlight the critical importance of early treatment intervention with a disease-modifying treatment, such as Mayzent, to ensure the best possible long-term outcomes for patients with MS who are experiencing progression,” said Bruce Cree, MD, PhD, MAS, Clinical Research Director and George A. Zimmermann Endowed Professor in Multiple Sclerosis, University of California, San Francisco, School of Medicine. “It’s never too early to stay ahead of progression in multiple sclerosis, since the early identification of physical and cognitive changes – even subtle ones – can indicate MS disease progression and therefore allow for timely intervention.”