Interim Phase III data for Arzerra in CLL meets primary endpoint - Genmab

Genmab has announced additional data from the interim analysis of the Phase III study, PROLONG, of Arzerra (ofatumumab) in patients with Chronic Lymphocytic Leukemia (CLL). The study evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete response or partial response after 2nd or 3rd line treatment for CLL. The improvement in the study’s primary endpoint, progression free survival (PFS), met the prespecified statistical significance level for the interim analysis. Patients who received ofatumumab maintenance treatment lived 13.4 months longer without their disease worsening (median PFS) than patients who received no further treatment. Median PFS was 28.6 months for the ofatumumab treatment arm and 15.2 months for the observation arm.

The amount of time until patients started their next therapy was significantly longer in the ofatumumab treatment arm than in the observation arm (median 38.0 months vs 27.4 months). There were no unexpected safety findings. Adverse events occurred in 87% of patients in the ofatumumab treatment arm versus 75% in the observation treatment arm. In the ofatumumab treatment arm, 25% of patients experienced grade 3-4 adverse events compared to 17% in the observation arm. Data to be presented in oral session at ASH Annual Meeting.