BioCentury
ARTICLE | Clinical News

Genmab's Darzalex passes second Phase III MM test

May 20, 2016 12:21 AM UTC

Genmab A/S (CSE:GEN) said an interim analysis of the Phase III POLLUX (MMY3003) study showed that Darzalex daratumumab met the primary endpoint of improving progression free survival (PFS) in relapsed or refractory multiple myeloma patients. Genmab said its partner, the Janssen Biotech unit of Johnson & Johnson (NYSE:JNJ), will unblind the trial early, and discuss potential regulatory submissions with regulators.

In the 569-patient study, Genmab said a combination of Darzalex plus Revlimid lenalidomide and dexamethasone reduced the risk of disease progression or death by 63% vs. Revlimid and dexamethasone alone at median follow-up of 13.5 months. Median PFS in the Darzalex arm has not yet been reached and was 18.4 months in the comparator group (HR=0.37, p<0.0001). ...