Positive top-line Phase III daratumumab results in MM

Danish biotech Genmab (Nasdaq: GMAB) late Wednesday released positive top-line results from the second part of the Phase III CASSIOPEIA (MMY3006) study of cancer drug daratumumab monotherapy as maintenance treatment versus observation (no treatment) for patients with newly-diagnosed multiple myeloma eligible for autologous stem cell transplant (ASCT).

Daratumumab, marketed under the trade name Darzalex, was licensed to Johnson & Johnson’s (NYSE JNJ) Janssen subsidiaries in 2012, and generated sales of $1.1 billion for the US group in the third quarter of this year, up 43.8% year-on-year.

The second part of the study, which is being conducted by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen Research & Development, met the primary endpoint of improving progression free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.53 (95% CI 0.42 – 0.68), p < 0.0001) resulting in a 47% reduction in the risk of progression or death in patients treated with daratumumab. The safety profile observed in this study was consistent with the known safety profile of daratumumab and no new safety signals were observed.