Amgen says Kyprolis, Darzalex combination hits main goal in Phase III multiple myeloma trial

Amgen announced results Friday from a Phase III study showing that its cancer drug Kyprolis (carfilzomib) in combination with Johnson & Johnson's Darzalex (daratumumab) plus dexamethasone significantly prolonged progression-free survival (PFS) compared with Kyprolis and dexamethasone alone in patients with relapsed or refractory multiple myeloma. David Reese, head of R&D at Amgen, said "results from the CANDOR study confirm the potential for Kyprolis to be used in combination with an anti-CD38 monoclonal antibody."

In the study, 466 patients with relapsed or refractory multiple myeloma who had already received one to three prior therapies were randomly assigned to treatment with Kyprolis plus Darzalex or Kyprolis alone, both in combination with dexamethasone. In addition to the main PFS goal, secondary objectives included overall response rate, minimal residual disease and overall survival.

Top-line results showed that the three-drug regimen reduced the risk of progression or death by 37% versus Kyprolis plus dexamethasone. Amgen said median PFS had not been reached by the cut-off date for patients in the Darzalex combination group, but was 15.8 months among those given Kyprolis alone. 

In regards to safety, Amgen noted that the adverse event rate was higher in the three-drug arm than for patients who received the two-drug regimen, although the events were "consistent with the known safety profiles of the individual agents." The company added that CANDOR results will be submitted for presentation at a future research conference and discussed with health authorities ahead of potential regulatory submissions. 

Kyprolis is approved in several markets for patients with relapsed or refractory multiple myeloma, including the US and Europe. Amgen gained rights to the drug, which generated $267 million in revenue in the second quarter, via its $10.4-billion purchase of Onyx Pharmaceuticals in 2013. 

Meanwhile, Johnson & Johnson acquired global rights to develop and commercialise Darzalex from Genmab in 2012 in a deal worth potentially more than $1.1 billion. The therapy is approved for several multiple myeloma indications, most recently gaining clearance in the US for use together with Celgene's Revlimid (lenalidomide) and dexamethasone in first-line multiple myeloma for patients not eligible for autologous stem cell transplant. Sales of Darzalex jumped 51.6% in the second quarter to $774 million.

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