Genmab announced that based on a planned review by the Data Monitoring Committee (DMC), two studies using daratumumab in combination with PD-1 inhibitors will be discontinued. The studies include daratumumab with atezolizumab for non-small cell lung cancer and daratumumab with JNJ-6372383 in multiple myeloma.
The DMC determined that there was no observed benefit in the treatment arm non-small cell lung cancer study with an increase mortality-related events.
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.
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. 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.
The MMY2036 study was a study to include up to 386 patients with relapsed or refractory multiple myeloma and test the use of a new JNJ 63723283 (PD-1 antibody) administered in combination with daratumumab or the use of daratumumab alone.
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Myeloma survivor, patient advocate, wife, mom of 6. Believer that patients can help accelerate a cure by weighing in and participating in clinical research. Founder of Myeloma Crowd by HealthTree and the HealthTree Foundation.