Benefit risk data analysis for Mavenclad to treat Multiple Sclerosis.- Merck KGaA.

Merck KGaA, announced positive benefit-risk data for its recently approved multiple sclerosis (MS) therapy, Mavenclad (Cladribine Tablets), at MS Paris 2017 (the Joint ECTRIMS-ACTRIMS Meeting) in Paris, France. A post hoc analysis in high disease activity subgroups from the 2-year CLARITY study has confirmed that Mavenclad significantly increased the proportion of patients with no evidence of disease activity (NEDA) compared with placebo (43.7% vs 9.0%). This analysis is consistent with results seen in the broader CLARITY patient population, and further supports the efficacy of Mavenclad for the treatment of relapsing MS.

Late-breaking safety analysis including patients with up to 8-years follow-up from the (3.5 mg/kg) cohorts of CLARITY, CLARITY Extension, ORACLE-MS studies and the PREMIERE registry also confirmed that despite the imbalance of malignancy cases in placebo-controlled trials, the overall incidence of malignancy in patients treated with Mavenclad (3.5 mg/kg) was not significantly different to the incidence in a matched population based on GLOBOCAN (0.97, 95% CI 0.44-1.85). Within the pooled safety analyses the incidence per 100 patient-years of malignancy was 0.293 (95% CI 0.158-0.544) for Mavenclad compared with 0.148 (95% CI 0.048-0.460) for placebo. The incidence of malignancies in the Mavenclad arm was shown to be constant and did not increase over time, in contrast to placebo.