Following a planned review, the Data Monitoring Committee (DMC) has recommended that the Phase Ib/II study (CALLISTO/LUC2001) of daratumumab in combination with atezolizumab versus atezolizumab monotherapy in patients with previously treated advanced or metastatic non-small cell lung cancer should be terminated.
In addition the phase I MMY2036 study of daratumumab plus JNJ-63723283, an anti PD-1 antibody in patients with multiple myeloma will be discontinued.
In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
The DMC determined that there was no observed benefit within the combination treatment arm, daratumumab plus atezolizumab, over atezolizumab monotherapy, and recommended termination of the study. In addition to the lack of benefit, the DMC noted a numerical increase in mortality-related events in the combination arm. Based on these findings, Janssen has made the decision also to discontinue the MMY2036 study, which was evaluating a combination of daratumumab and anti-PD-1 (JNJ-63723283) in patients with Multiple Myeloma. Janssen has informed Health Authorities about these events and has contacted its partner companies conducting daratumumab and anti-PD-(L)1 combination studies to discuss ceasing enrollment and dosing of the combination while the data is being further investigated.
“While we are disappointed that the studies will be discontinued, Genmab fully supports Janssen’s decision as patient safety is paramount in drug development. We look forward to gaining a better understanding of the data upon further analysis. We are pleased that the development program for daratumumab remains expansive and continues to benefit patients with Multiple Myeloma” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.