International biotechnology company Genmab said a data monitoring committee (DMC) recommended that the Phase Ib/II study (CALLISTO/LUC2001) being run by partner Janssen should be terminated. The DMC concluded that there was no observed benefit within the combination treatment arm [May 26 2018]. The DMC also noted a numerical increase in mortality-related events in the combination arm.
In addition, the phase I MMY2036 study of daratumumab plus JNJ-63723283, an anti PD-1 antibody in patients with multiple myeloma will be discontinued.
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.
Jan van de Winkel, chief executive officer of Genmab, said: “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.”
In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialise daratumumab.