#MSVirtual2020 – Novartis to Present Latest Data on Kesimpta, Mayzent and Gilenya

Marta Figueiredo, PhD avatar

by Marta Figueiredo, PhD |

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Novartis will present the latest clinical data on three of its approved multiple sclerosis (MS) therapies — Kesimpta (ofatumumab), Mayzent (siponimod), and Gilenya (fingolimod) — at the  MSVirtual2020 meeting that opens today.

The 8th joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) runs virtually through Sunday, Sept. 13.

Across 48 oral and posters presentations, Novartis will share new safety and effectiveness data on its leading MS portfolio.

“As a global leader in neuroscience, we have been committed to bringing life-changing therapies to people living with diseases like MS for more than 75 years,” Estelle Vester-Blokland, the company’s global head of Neuroscience Medical Affairs, said in a press release.

“For the first time in our growing portfolio, we are proud to be presenting data from three of our approved MS treatments across the MS disease spectrum, which is a significant milestone of our commitment to reimaging medicine for the MS community,” Vester-Blokland added.

Kesimpta — an anti-CD20 antibody that targets B-cells, the immune cells that drive attacks against myelin in MS — is the latest to enter Novartis’ MS portfolio of approved therapies.

It was approved in the U.S. in August for the treatment of adults with relapsing MS, including clinically isolated syndrome, relapsing-remitting disease (RRMS), and active secondary progressive MS (SPMS).

According to the company, Kesimpta is the first and only approved B-cell targeting therapy for MS that can be self-administered under the skin using an autoinjector pen, once a month, at home.

Kesimpta’s approval was based on results from two Phase 3 clinical trials — ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231) — which compared Kesimpta with Sanofi Genzyme’s oral MS therapy Aubagio. Aubagio is thought to work by blocking the activity of B-cells and T-cells, another type of immune cell involved in MS.

New data from the ASCLEPIOS trials being presented comes from a sub-group analysis. It shows that Kesimpta is superior to Aubagio at dropping relapse rates and delaying disease progression in newly diagnosed patients with no prior treatments.

These findings suggest that relapsing MS patients may benefit from using Kesimpta as a first-line therapy.

In addition, no new safety concerns were identified in an extended analysis of Kesimpta-treated patients, the company states, with the therapy showing a safety profile consistent with that previously reported. New data also support the use of neurofilament light chain (NfL) blood levels as a biomarker of a patient’s likely risk of new brain lesions and further brain shrinkage.

Novartis will also discuss new results from its two approved sphingosine-1-phosphate (S1P) receptor modulators: Mayzent and Gilenya. Both therapies work by preventing immune cells from leaving the lymph nodes, entering blood circulation and reaching the brain and spinal cord, where they can promote further inflammation and nerve cell damage.

According to the company, Mayzent is the first and only oral disease-modifying therapy (DMT) proven to slow disability progression in a broad range of SPMS patients, while Gilenya is the only oral DMT approved to treat adults and children, ages 10 and older, with relapsing forms of MS.

The ongoing and long-term Phase 3 EXPAND clinical trial (NCT01665144) is evaluating Mayzent’s safety and effectiveness in SPMS patients. It includes a completed placebo-controlled part, followed by an open-label extension in which all are given the therapy.

An interim analysis of the trial’s long-term data found sustained benefits in disability progression, cognitive performance, and relapse rates for up to five years in active SPMS patients continuously treated with Mayzent, compared with those who switched from placebo to Mayzent in the extension part.

These findings highlight the potential value of early treatment initiation with Mayzent. Further EXPAND results continue to show that Mayzent significantly delays cognitive decline in SPMS patients.

Data from the ongoing Phase 3 EXCHANGE trial (NCT03623243), a six-month study in relapsing MS patients switching from other treatments — oral, injectable, or infusion — to Mayzent, also show good safety and tolerability. This open-label trial is still enrolling up to 400 adults with advancing disease at select sites across the U.S. Information is available here.

Additional safety findings from Gilenya studies being presented highlight a low therapy-associated risk of progressive multifocal leukoencephalopathy (PML) and no increased risk of major congenital malformations in babies born of Gilenya-treated women. (PML is a rare and often fatal disease that can sometimes occur due to low immune cell numbers in the brain.)

Results from the completed Phase 4 FLUENT trial (NCT03257358), which assessed changes in immune biomarkers in relapsing MS patients on Gilenya, will also be presented at the meeting.

Novartis will also share new data on MSProDiscuss, a first-of-its-kind, clinically validated, algorithm-based digital tool developed by a team of researchers from Germany, Canada, its own company, and Adelphi Values.

The tool, for healthcare professionals, is designed to facilitate physician-patient conversations on signs of MS progression, and the earlier identification of people transitioning from RRMS to SPMS.

A large, real-world qualitative survey on MSProDiscuss in 34 countries found that the tool was indeed useful, easing progression-related conversations with MS patients in daily practice.

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