Positive top-line Phase III results for subcutaneous daratumumab

Danish biotech firm Genmab (OMX: GEN) has announced positive top-line results from the Phase III COLUMBA study (MMY3012) of subcutaneous (SC) versus intravenous (IV) daratumumab for patients with relapsed or refractory multiple myeloma.

The results showed that SC administration of daratumumab, marketed under the trade name Darzalex, 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 499mg/mL (n=149) versus 463mg/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.