High NEDA rates after 2 years of ocrelizumab

In the CASTING open-label single-arm prospective trial of ocrelizumab, the proportion of patients with no evidence of disease activity (NEDA) at year 2 was high: 74.8%–80.4% of patients were free of clinical disease activity, while 91.5% of patients were free of MRI activity [1]. NEDA was maintained from year 1 over year 2.

CASTING is a phase 3b study evaluating the efficacy and safety of ocrelizumab in relapsing-remitting multiple sclerosis (RRMS) patients with suboptimal response to 1 or 2 prior disease-modifying treatments (DMTs). The intention-to-treat (ITT) population included 680 patients. After 2 years, 74.8% of patients had NEDA; 80.4% had no evidence of clinical activity, 91.5% had no evidence of MRI activity, and 89.8% had no relapses.

The exploratory endpoint of 2-year NEDA with MRI from screening was reached by 52.0% of patients. This lower percentage was mainly due to the lower percentage of patients with no evidence of MRI activity, which dropped to 63.8%. The percentage of no evidence of clinical activity after 2 years was 80.6%. NEDA was maintained in year 2 when analysed by epoch. In the first epoch (baseline to year 1), NEDA was 82.6%, in the second epoch (year 1 to year 2) 87%.

Safety results over 2 years were consistent with prior studies, with no newly observed signals. In the ITT population of 680 patients, 49 (7.1%) experienced a serious adverse event, leading to treatment discontinuation in 5 patients.

1. Vermersch P, et al. Abstract LBN05, EAN 2020.

 



Posted on 10 September 20205 November 2020