Novartis Multiple Sclerosis Drug Kesimpta Shows Substantial Benefit Of Up To 6 Years

Novartis AG NVS released data from the ALITHIOS open-label extension study showing sustained efficacy of first-line, continuous Kesimpta (ofatumumab) treatment for up to six years in recently diagnosed relapsing multiple sclerosis.

Recently diagnosed is defined as untreated patients starting treatment within three years of initial diagnosis.

These efficacy outcomes included 44% fewer relapses; 96.4% and 82.7% reductions in MRI lesions (Gd+ T1 and neT2), respectively; and 24.5% and 21.6% fewer 3- and 6-month confirmed disability worsening (CDW) events, respectively, versus those who switched from Sanofi SA’s SNY Aubagio (teriflunomide) to Kesimpta.

In the first analysis, the low annualized relapse rate (ARR) experienced by recently diagnosed treatment-naïve RMS patients was further reduced in the ALITHIOS open-label extension study, from 0.104 to 0.050 (52.0% reduction), corresponding to an adjusted ARR of one relapse per 20 years.

• Rates of 3- and 6-month progression independent of relapse activity (PIRA) with first-line Kesimpta were also lower versus switch.
• The observed rapid increase in the proportion of participants with no evidence of disease activity (NEDA-3) with continuous first-line Kesimpta treatment was maintained up to six years.
• Patients initially randomized to teriflunomide, improvements across several efficacy outcomes were seen after switching to Kesimpta, including significant reductions in ARR (71.3%) and in MRI lesion activity (Gd+ T1: 98.5% reduction; neT2: 93% reduction), and rapid increase in rates of NEDA-3.1.
• 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.

The second analysis looked at the overall ALITHIOS population:

• Data showed sustained efficacy of continuous Kesimpta up to six years, including low ARR (49.9% reduction between core Phase III trials and extension phase), suppression of MRI lesion activity (Gd+ T1: 56.7% reduction; neT2: 89.3% reduction), sustained reduction of 6-month CDW events (14.1%, relative to the switch group), lower rates of 6-month PIRA, and sustained high rates of NEDA-3.2.
• People switching from teriflunomide to Kesimpta experienced reductions in ARR (73.8%) and MRI lesion activity (Gd+ T1: 97.7% reduction; neT2: 91.8% reduction) and a rapid increase in NEDA-3 rates during the extension period.

Treatment with Kesimpta for up to six years was well-tolerated with no unexpected safety signals identified.

In fiscal year 2023, Kesimpta’s sales almost doubled to $2.2 billion.

Price Action: NVS shares are up 0.15% at $93.34 on the last check Wednesday.

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