Phase III COLUMBA study of Darzalex multiple myeloma met both co-primary endpoints in multiple myeloma.- Genmab

Genmab announced topline results from the Phase III COLUMBA study (MMY3012) of subcutaneous (SC) versus intravenous (IV) Darzalex (daratumumab) for patients with relapsed or refractory multiple myeloma. The results showed that SC administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 is non-inferior to IV administration of daratumumab with regard to the co-primary end points of overall response rate (ORR) and Maximum Trough concentration (Ctrough) of daratumumab on day 1 of the third treatment cycle. The ORR for patients treated with SC daratumumab was 41.1% (n=263) versus 37.1% in patients treated with IV daratumumab (n= 259).

The lower limit of the 95% Confidence Interval (CI) for the ratio of the two met the specified non-inferiority criterion for this co-primary endpoint. The geometric mean of Ctrough for patients treated with SC daratumumab was 499 mg/mL (n=149) versus 463 mg/mL in patients treated with IV daratumumab (n= 146). The lower limit of the 95% CI for the ratio of the two met the specified non-inferiority criterion for this co-primary endpoint. No new safety signals were detected and Janssen Biotech, Inc., which licensed daratumumab from Genmab in 2012, will discuss the potential for a regulatory submission for this formulation with health authorities, and plans to submit the data to an upcoming medical conference and for publication in a peer-reviewed journal.