Novartis Highlights Significant Efficacy of Kesimpta, a Subcutaneous Anti-CD20 B-Cell Therapy, in Newly Diagnosed Relapsing Multiple Sclerosis Patients

September 12, 2020 /Bio ValleyBIOON/ --Novartis(Novartis) recently at the 8th ACTRIMS-ECTRIMS JointMeetingAt MSVirtual2020, results were presented evaluating the multiple sclerosis drug Kesimpta (ofatumumab, formerly OMB157) for the treatment of newDiagnosisNew post-hoc analysis data from two pivotal global Phase III studies (ASCLEPIOS I and II; n=615) evaluating the efficacy and safety of Kesimpta in patients with relapsing multiple sclerosis (RMS), along with results from ongoing safety studies. These data further support Kesimpta as a preferred treatment option for adults with RMS.

Kesimpta is a novel targeted B-cell therapy that received U.S. approval in August this yearFDAApproved as a subcutaneous injection for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

It is worth mentioning that,Kesimpta is the first and only B-cell therapy that can be easily administered and managed at home, delivered via the Sensoready autoinjector pen as a once-monthly subcutaneous injection.Clinical data demonstrate that it exhibits very high efficacy and a similar safety profile compared to the oral drug Aubagio (teriflunomide), positioning it as the preferred treatment option for a broad population of patients with relapsing multiple sclerosis (RMS). Aubagio, an oral multiple sclerosis (MS) medication from Sanofi, is a leading oral disease-modifying therapy (DMT) for MS in the industry.

One of the goals of managing RMS is to preserve neurological function and slow the progression of disability. Although several disease-modifying therapies (DMTs) are available for the treatment of RMS, most patients with RMS still experience disease activity. Evidence suggests that early initiation of high-efficacy therapy can improve long-term outcomes in patients with RMS. Data from two pivotal Phase III ASCLEPIOS studies demonstrated that, compared with Aubagio, Kesimpta significantly reduced the risk of relapse, confirmed disability progression, gadolinium-enhancing T1 brain lesions, and new or enlarging T2 lesions. Post hoc analyses also indicated that Kesimpta may suppress new disease activity in patients with RMS.

NovartisDedicated to bringing Kesimpta to patients around the world, with additional regulatory filings currently underway globally; Kesimpta is expected to receive regulatory approval in Europe by the second quarter of 2021.

The post-hoc analysis presented at this meeting evaluated the efficacy and safety of Kesimpta in a subgroup of patients with early relapsing multiple sclerosis (RMS), specifically those who were newly diagnosed and treatment-naïve. The baseline characteristics of the newly diagnosed (within 3 years prior to screening) and treatment-naïve (no prior disease-modifying therapy [DMT]) subgroup were typical of patients with early multiple sclerosis (median age and sinceDiagnosisThe durations of multiple sclerosis since onset were 36 years and 0.35 years, respectively).

The study results indicated that: (1) Compared with Aubagio, Kesimpta significantly reduced the annualized relapse rate (ARR) by 50.3% (0.09 vs. 0.18; p<0.001). (2) Compared with Aubagio, Kesimpta significantly reduced the mean number of gadolinium-enhancing (Gd+) T1 lesions by 95.4% (0.02 vs. 0.39; p<0.001) and the mean number of new or enlarging T2 lesions by 82.0% (0.86 vs. 4.78; p<0.001). (3) Compared with Aubagio, Kesimpta reduced the relative risk of 3-month confirmed disability worsening (CDW) by 38% (P=0.065) and the relative risk of 6-month CDW by 46% (P=0.044).

Another post hoc analysis presented on the same poster at the MSVirtual2020 conference showed that in the same newDiagnosisIn the subgroup of treatment-naïve patients, compared with Aubagio, the likelihood of achieving no evidence of disease activity (NEDA-3: no relapses, no MRI lesions, and no disability progression) with Kesimpta was significantly more than 3-fold higher in the first year (0–12 months) (47.0% vs. 24.7%, p < 0.001) and more than 14-fold higher in the second year (12–24 months) (92.1% vs. 46.8%, p < 0.001). Overall, the safety profile of Kesimpta was similar to that of Aubagio.

Another safety analysis (n=1,873) from the ongoing Phase IIIb ALITHIOS trial reported on long-term treatment with Kesimpta in patients with relapsing multiple sclerosis (RMS). The ALITHIOS trial included patients who continued Kesimpta treatment from the Phase III ASCLEPIOS trials or the Phase II APLIOS trial (continuous), as well as patients who switched from Aubagio to Kesimpta in the ASCLEPIOS trials (new switchers). The results showed no new safety signals, highlighting that the safety profile of Kesimpta in RMS patients is consistent with the data reported in the core studies.

Furthermore, another analysis combining the ASCLEPIOS trials demonstrated the prognostic value of serum neurofilament light chain (NfL) in assessing the future disease course in patients with relapsing multiple sclerosis (RMS). The value of measuring serum NfL is also supported by the results of the APLIOS study, which showed a significant association between NfL and disease activity, whether manifested as new gadolinium-enhancing T1 lesions or relapses.

Dr. Amit Bar-Or of the University of Pennsylvania commented, “These encouraging data indicate that newDiagnosisand treatment-naïve patients receiving Kesimpta have the potential to benefit from reduced disease activity.”.

Krishnan Ramanathan, Global Program Head for Neuroscience at Novartis, stated, “Overall, these data add to the substantial body of evidence demonstrating that Kesimpta is a potent B-cell therapy for patients with RMS, including those newDiagnosisor in patients who had previously received treatment, with a favorable safety profile.Novartis"Committed to reimagining care, bringing innovative treatment options to people living with this disease."

As a next-generation B-cell depleting agent, Kesimpta offers the advantage of more rapid B-cell depletion while preserving immune function, along with the convenience of self-administration via once-monthly subcutaneous injection. Since its market launch, it is poised to challenge Roche’s rapidly growing CD20-targeted therapy, Ocrevus (ocrelizumab), whose global sales surged by 57% in 2019, reaching an impressive CHF 3.708 billion.

Multiple Sclerosis (MS) impairs the normal functioning of the brain, optic nerves, and spinal cord through inflammation and tissue damage, affecting approximately 2.3 million people worldwide. The disease is typically classified into three types: Relapsing-Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS, generally defined by the overall accumulation of cognitive and physical changes and disability), and Primary Progressive Multiple Sclerosis (PPMS). Approximately 85% of patients initially present with the relapsing form of multiple sclerosis.

In this field,NovartisThe product portfolio includes: Gilenya (fingolimod, an S1P modulator), Mayzent (siponimod, a next-generation S1P modulator), and Extavia (interferon beta-1b for subcutaneous injection). In addition, its Sandoz division markets Glatopa (glatiramer acetate, 20 mg/mL and 40 mg/mL) in the United States, which is a generic version of Teva’s blockbuster multiple sclerosis drug Copaxone. (Bioon.com)

Original Source: Novartis presents data at ACTRIMS-ECTRIMS for Kesimpta® (ofatumumab) in newly diagnosed treatment-naïve adults with relapsing multiple sclerosis