Janssen ends combo with daratumumab
Following reports of an increase in mortality in a study that combined Genmabs anti-CD38 daratumumab with a PD-L1 blocker, Genmabs partner Janssen has stopped a study combining daratumumab with its PD1 blocker JNJ-63723283 in multiple myeloma.
In an interim review of a Phase Ib/II study of daratumumab plus Roche’s anti-PDL1 antibody atezolizumab (CALLISTO/LUC2001) in patients with previously treated non-small cell lung cancer (NSCLC), a Data Monitoring Committee (DMC) noted a numerical increase in mortality-related events in the combination arm over atezolimumab monotherapy. Furthermore, the combo showed no efficacy benefit vs atezolimumab monotherapy. Based on these results, Janssen decided to terminate a Phase I study (MMY2036), in which daratumumab was tested in combination with Janssens PD1 blocker (JNJ-63723283) in patients with multiple myeloma.
According to Genmab, data of the Phase I trial are being further investigated. However, Janssen decided to discontinue the MMY2036 study. Janssen informed Health Authorities and has contacted its partner companies conducting daratumumab and anti-PD-(L)1 combination studies to discuss ceasing enrollment and dosing of the combination.
In August 2012, Genmab granted Janssen Biotech an exclusive worldwide license to develop, manufacture and commercialize daratumumab. While we are disappointed that the studies will be discontinued, Genmab fully supports Janssens 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, Ph.D., Chief Executive Officer of Genmab.
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