Clinical Trials Testing Daratumumab With Checkpoint Inhibitors in Multiple Myeloma Halted
Posted: Monday, July 16, 2018
Genmab recently announced that the phase I randomized, multicenter MMY2036 study of daratumumab plus JNJ-63723283, an investigational anti–PD-1 antibody, in patients with multiple myeloma will be discontinued. This decision is based on a data monitoring committee recommendation that the phase Ib/2 LUC2001 trial of the combination of daratumumab and the PD-L1 inhibitor atezolizumab in patients with previously treated advanced or metastatic non–small cell lung cancer be terminated.
The data monitoring committee determined there was no observed benefit within the combination treatment arm (daratumumab plus atezolizumab). In addition to the lack of benefit, the data monitoring committee noted a numerical increase in mortality-related events in the combination arm.
The Health Authorities have been informed about these events, and partner companies conducting daratumumab and anti–PD-L1 combination studies have been contacted to consider ceasing enrollment and dosing of the combination while the data are being investigated further.
