Following a planned review, the Data Monitoring Committee (DMC) has recommended termination of the Phase Ib/II study of daratumumab in combination with atezolizumab versus atezolizumab monotherapy in patients with previously treated non-small cell lung cancer (NSCLC).
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This recommendation comes after the DMC found no observed benefit with the combination treatment arm over the monotherapy arm. Additionally, the committee noted a numerical increase in mortality-related events in the combination arm.
Based on these findings, Janssen (which was granted an exclusive worldwide licence to develop, manufacture and commercialise daratumumab by Genmab in August 2012) has taken the decision to discontinue the MMY2036 study — evaluating a combination of daratumumab and anti-PD-1 (JNJ-63723283) in patients with multiple myeloma. These events have been reported to the Health Authorities and partner companies have also been contacted to discuss the cessation of enrolment and dosing of the combination therapy while further investigations of the data are performed.
“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,” stated Jan van de Winkel, PhD, chief executive officer of Genmab.