Genmab reports stopping of studies of Daratumumab in combination with anti-PD-(L)1 by Janssen.
M2 PHARMA-May 28, 2018-Genmab reports stopping of studies of Daratumumab in combination with anti-PD-(L)1 by Janssen
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Biotechnology company Genmab A/S (CPH:GEN) announced on Friday that following a planned review, the Data Monitoring Committee (DMC) has recommended that the phase Ib/II study (CALLISTO/LUC2001) of daratumumab in combination with atezolizumab versus atezolizumab monotherapy in patients with previously treated advanced or metastatic non-small cell lung cancer should be terminated.
Also, the phase I MMY2036 study of daratumumab plus JNJ-63723283, an anti PD-1 antibody in patients with multiple myeloma will be discontinued.
Reportedly, the DMC determined that there was no observed benefit within the combination treatment arm, daratumumab plus atezolizumab, over atezolizumab monotherapy, and recommended termination of the study. In addition to the lack of benefit, the DMC noted a numerical increase in mortality-related events in the combination arm.
According to the company, based on these findings, Janssen Biotech Inc (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 enrolment and dosing of the combination while the data is being further investigated.
Genmab added that it fully supports Janssen's decision as patient safety is paramount in drug development.
In August 2012, Genmab had granted Janssen an exclusive worldwide license to develop, manufacture and commercialise daratumumab. A comprehensive clinical development programme for daratumumab is ongoing, including multiple phase III studies in smouldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases, such as NKT-cell lymphoma, myelodysplastic syndromes, B and T-ALL. Daratumumab has received two Breakthrough Therapy Designations from the US FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.
Genmab is specialising in the creation and development of differentiated antibody therapeutics for the treatment of cancer. The company has two approved antibodies, DARZALEX (daratumumab) for the treatment of certain multiple myeloma indications and Arzerra (ofatumumab) for the treatment of certain chronic lymphocytic leukaemia indications.
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|Date:||May 28, 2018|
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