Novartis Reports New Long-Term Phase 3 Data Demonstrating Sustained Efficacy and Safety of Kesimpta in Relapsing Multiple Sclerosis

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Recently, Novartis announced new long-term data from the Phase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension study. The data showed that Kesimpta (ofatumumab) demonstrated sustained efficacy and safety over four years of treatment in patients with relapsing multiple sclerosis (RMS), consistently reducing the risk of disability progression. Additionally, Kesimpta maintained a safety profile similar to that observed in the pivotal Phase 3 clinical trials, with no new safety risks identified.

In addition to confirming the sustained efficacy of Kesimpta for up to 4 years, patients who switched from the oral medication Aubagio (teriflunomide) to Kesimpta during the extension phase showed a significant reduction in relapse rates and MRI lesions. In patients treated with Kesimpta for 4 years, immunoglobulin G (IgG) levels remained stable, while average immunoglobulin M (IgM) levels decreased but remained above the lower limit of normal, with no observed association between Ig levels and serious infections. The overall incidence of adverse events (AEs) and serious AEs, as well as the overall incidence of serious infections, was consistent with what was observed in the Phase 3 ASCLEPIOS I/II trials and was not affected by the COVID-19 pandemic.

Moreover, data from the ongoing KYRIOS open-label prospective study show that multiple sclerosis (MS) patients treated with Kesimpta can mount an immune response to the COVID-19 mRNA vaccine. In the study, all patients who received the vaccine while continuing Kesimpta treatment developed an immune response one week after the initial vaccination. Patients who received a booster during treatment showed an immune response similar to those who had received a booster before treatment. In the ALITHIOS trial, which examined injection-related reactions (IRR) associated with Kesimpta subcutaneous injections, and in post-marketing reports, the severity of IRR was mostly mild to moderate (99%), with no medically confirmed fatal or life-threatening IRR related to Kesimpta found. These findings are consistent with the results from the phase 3 ASCLEPIOS I/II trials.

Public data show that multiple sclerosis is a chronic inflammatory disease of the central nervous system, characterized by demyelination and axonal damage in the brain, optic nerves, and spinal cord. It is estimated that MS affects approximately 2.3 million people worldwide.

Kesimpta is a novel targeted precision B-cell therapy that has been approved in the United States, the European Union, China, and other regions for the treatment of adult patients with relapsing multiple sclerosis. Kesimpta is a fully human anti-CD20 monoclonal antibody that works by binding to the CD20 molecule on the surface of B cells and inducing potent B-cell lysis and depletion. In terms of administration, the drug is self-administered via subcutaneous injection once a month.

Reference Source: Novartis Presents Positive New Data on Relapsing MS Treatment