Studies of Daratumumab in Combination With Anti–PD-L1/Anti–PD-1 Agents Stopped

On May 26, Genmab A/S announced that following a planned review, the Data Monitoring Committee (DMC) has recommended that the phase Ib/II study (CALLISTO/LUC2001) of daratumumab (Darzalex) in combination with the anti–programmed cell death ligand 1 (PD-L1) antibody atezolizumab (Tecentriq) vs atezolizumab monotherapy in patients with previously treated advanced or metastatic non–small cell lung cancer (NSCLC) should be terminated. In addition, the phase I MMY2036 study of daratumumab plus JNJ-63723283, an anti–programmed cell death protein 1 (PD-1) antibody, in patients with multiple myeloma will be discontinued.

The DMC determined that there was no observed benefit within the combination daratumumab plus atezolizumab treatment arm 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. 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 are being further investigated.

In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture, and commercialize daratumumab.

“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,” said Jan van de Winkel, PhD, Chief Executive Officer of Genmab.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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