Novartis announces data from the ALITHIOS study of Kesimpta

Novartis announced data from the ALITHIOS open-label extension study showing sustained efficacy of first-line, continuous Kesimpta treatment for up to six years in recently diagnosed treatment-naive people living with relapsing multiple sclerosis. These efficacy outcomes included 44% fewer relapses; 96.4% and 82.7% reductions in MRI lesions, respectively; and 24.5% and 21.6% fewer 3- and 6-month confirmed disability worsening events, respectively, versus those who switched to Kesimpta from teriflunomide. Study Results: In the first analysis, the low annualized relapse rate experienced by recently diagnosed treatment-naive people living with RMS receiving continuous Kesimpta during the core Phase III trials was further reduced in the ALITHIOS open-label extension study, from 0.104 to 0.050, corresponding to an adjusted ARR of one relapse per 20 years. Rates of 3- and 6-month progression independent of relapse activity with first-line Kesimpta were also lower versus switch. In RDTN people living with RMS initially randomized to teriflunomide, improvements across several efficacy outcomes were seen after switching to Kesimpta, including significant reductions in ARR and in MRI lesion activity, and rapid increase in rates of NEDA-3. However, rates of 3- and 6-month CDW events remained higher compared to patients receiving continuous Kesimpta, indicating that the efficacy benefit of first-line Kesimpta on delaying disability worsening was not fully achieved in the switch group. Across both continuous and switch groups, nine out of 10 participants achieved NEDA-3 at Year 6. Similar results were seen in the second analysis, which looked at the overall ALITHIOS population. Data showed sustained efficacy of continuous Kesimpta up to six years, including low ARR, suppression of MRI lesion activity, sustained reduction of 6-month CDW events, lower rates of 6-month PIRA, and sustained high rates of NEDA-3. At Year 6, NEDA-3 status was achieved in nine out of 10 participants in both the continuous and switch groups. The study also found that treatment with Kesimpta for up to six years was well-tolerated with no unexpected safety signals identified. The rates of adverse events, serious AEs, serious infections, and malignancies remained stable with no increased risks over six years.