Darzalex meets endpoint in late-stage multiple myeloma trial

pharmafile | May 19, 2016 | News story | Research and Development Genmab, Janssen, daratumumab, darzalex, dexamethasone, lenalidomide, phase 3, phase III, trial 

Genmab has announced that positive results from a Phase III trial evaluating Darzalex (daratumumab), which is being developed in partnership with Janssen, in combination with other drugs for the treatment of multiple myeloma.

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterised by an excess proliferation of plasma cells. It is the third most common blood cancer after leukaemia and lymphoma, and it was estimated that 87,084 would die from the disease across the world in 2015.

The Phase III POLLUX study enrolled 569 patients who had relapsed or refractory multiple myeloma. The use of Darzalex in combination with lenalidomide and dexamethasone met the primary endpoint of improving progression free survival compared with those two drugs alone.

Patients receiving Darzalex in the drug combo had a 63% reduction in risk of their disease progressing, compared to patients not receiving Genmab’s drug.

Based on the results at the pre-planned interim stage, an independent data monitoring committee recommended that data be unblended. Patients originally receiving just lenalidomide and dexamethasone alone will now have the option of receiving Darzalex monotherapy.

Janssen, who licensed the drug from Genmab in 2012, will now interact with regulatory authorities to seek approval for Darzalex in this indication.

Jan van de Winkel, chief executive officer of Genmab, comments: “The POLLUX study is the second key Phase III study of daratumumab to meet the primary endpoint at a pre-planned interim analysis and demonstrates a favourable benefit-risk ratio. We have now seen that daratumumab can potentially be used to effectively treat relapsed or refractory multiple myeloma in combination with either lenalidomide or bortezomib, two standard of care multiple myeloma treatments.”

Sean Murray

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