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Janssen to halt studies of daratumumab in combination with anti-PD-(L)1

PBR Staff Writer Published 28 May 2018

Genmab announced that Janssen will discontinue the phase Ib/II study of daratumumab in combination with atezolizumab against atezolizumab monotherapy in patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC).

The phase I MMY2036 study of daratumumab plus JNJ-63723283, an anti PD-1 antibody in patients with multiple myeloma, will also be terminated.

The Data Monitoring Committee (DMC) has recommended to stop the trial, as there was no observed benefit within the combination treatment arm daratumumab plus atezolizumab over atezolizumab monotherapy.

Janssen has decided to discontinue the MMY2036 study based on the results, which was assessing a combination of daratumumab and anti-PD-1 (JNJ-63723283) in patients with multiple myeloma.

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

Genmab CEO Dr Jan van de Winkel 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.”

The randomized, multicenter and phase Ib/II study recruited 98 patients with previously treated advanced or metastatic NSCLC.

Patients are randomized to secure daratumumab at 16 milligrams per kilogram (mg/kg) weekly for 3 cycles and on day 1 of every 21-day cycle thereafter.

According to Genmab, the primary endpoint of the study is percentage of patients with ORR, defined as percentage of patients with PR or CR as defined by Response Evaluation Criteria in Solid Tumors (RECIST).

The MMY2036 is a randomized, multicenter and multiphase study, which enrolled up to 386 patients with relapsed or refractory multiple myeloma.

Around six subjects will be recruited in Part 1(a safety run-in cohort) followed by 80 subjects randomly assigned in a 1:1 ratio to the two reatment arms in Part 2.

In the US, Darzalex (daratumumab) injection is indicated for intravenous infusion is indicated in combination with bortezomib, melphalan and prednisone to treat patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.