Amgen says Kyprolis and Darzalex combo meets Ph III goals

The world’s largest biotech firm Amgen (Nasdaq: AMGN) on Friday announced positive Phase III CANDOR study results evaluating its Kyprolis (carfilzomib) in combination with dexamethasone and Johnson & Johnson’s (NYSE: JNJ) Darzalex (daratumumab) (KdD) compared to Kyprolis and dexamethasone alone (Kd) for the treatment of multiple myeloma.

The Kyprolis and Darzalex combo met its primary endpoint of progression-free survival (PFS). The regimen resulted in a 37% reduction in the risk of progression or death in patients with relapsed or refractory multiple myeloma treated with KdD (HR=0.630; 95% CI: 0.464, 0.854; p=0.0014). The median PFS for patients treated with Kd alone was 15.8 months, while the median PFS for patients treated with KdD has not been reached by the cut-off date.

"The potential to combine Kyprolis and Darzalex, two powerful targeted agents, represents an additional therapeutic approach for patients with relapsed or refractory multiple myeloma," said Dr David Reese, executive vice president of R&D at Amgen. "The results from the CANDOR study confirm the potential for Kyprolis to be used in combination with an anti-CD38 monoclonal antibody," he noted.