A combination of daratumumab (Janssen’s Darzalex) and atezolizumab (Roche’s Tecentriq) has failed to show any benefit over the latter alone in a mid-stage trial involving patients with pre-treated metastatic non-small cell lung cancer.
Genmab said a data monitoring committee recommended that the Phase Ib/II study (CALLISTO/LUC2001) being run by partner Janssen should be terminated, having concluded that there was no observed benefit within the combination treatment arm.
Moreover, the DMC also noted a numerical increase in mortality-related events in the combination arm.
Based on the findings, Janssen said it would also terminate a Phase I MMY2036 study of daratumumab plus the anti PD-1 antibody JNJ-63723283 in patients with multiple myeloma.
“While we are disappointed that the studies will be discontinued, Genmab fully supports Janssen’s decision as patient safety is paramount in drug development,” said the firm’s chief executive Jan van de Winkel.
“We look forward to gaining a better understanding of the data upon further analysis.”
In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialise daratumumab.