Genmab A/S (CPH: GMAB), a biotechnology company specialising in the creation and development of differentiated antibody therapeutics for the treatment of cancer, on Friday reported topline results from the phase III CANDOR study, sponsored by Amgen, of daratumumab in combination with carfilzomib and dexamethasone (Kd) versus Kd alone in patients with multiple myeloma who have relapsed after one to three prior therapies.
The company said this study met the primary endpoint of improving progression free survival (PFS).
Also, there was a higher frequency of adverse events reported with daratumumab plus Kd, a three-agent regimen, than with Kd, a two-agent regimen. The types of observed adverse events were consistent with the known safety profiles of the individual agents. The most frequently reported treatment-emergent adverse events (greater than or equal to 20%) in the daratumumab plus Kd arm were thrombocytopenia, anaemia, diarrhoea, hypertension, upper respiratory tract infection, fatigue and dyspnoea.
According to the company, this CANDOR data will be submitted to a future medical meeting and Amgen will discuss the data with health authorities in preparation for regulatory submissions.
In August 2012, Genmab had granted Janssen Biotech Inc an exclusive worldwide license to develop, manufacture and commercialise daratumumab.
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