CANDOR clinical trial results : Amgen said that a phase 3 study assessing Kyprolis (carfilzomib) in combination with dexamethasone and Johnson & Johnson’s Darzalex (daratumumab) (KdD) compared to Kyprolis and dexamethasone alone (Kd), called CANDOR, met its primary endpoint of progression-free survival (PFS) in multiple myeloma patients.
The Amgen clinical trial featured 466 relapsed or refractory multiple myeloma patients who had been subjected to one to three prior therapies for their condition.
The US biotech company said that the three agent-regimen delivered a 37% reduction in the risk of progression or death in patients having relapsed or refractory multiple myeloma, who were treated with KdD.
The median PFS for patients in the Kd arm was 15.8 months, while the median PFS for patients in the KdD arm did not reach by the cut-off date, said Amgen.
David M. Reese – executive vice president of Research and Development at Amgen, commenting on the CANDOR clinical trial results, said: “The potential to combine Kyprolis with Darzalex, two powerful targeted agents, represents an additional therapeutic approach for patients with relapsed or refractory multiple myeloma.
“The results from the CANDOR study confirm the potential for Kyprolis to be used in combination with an anti-CD38 monoclonal antibody.
Amgen said that there was a higher frequency of adverse events noted in the three-agent regimen arm of KdD, than in Kd, the two-agent regimen.
The types of observed adverse events were on par with the existing safety profiles of the individual agents, said the US biotech company.
Ajai Chari – associate professor of medicine, the director of clinical research in the Multiple Myeloma Program and the associate director of clinical research at Mount Sinai Cancer Clinical Trials Office, commenting on the CANDOR clinical trial results, said: “While treatment advances have improved outcomes for patients with multiple myeloma, there remains a need for additional therapeutic options for patients who have relapsed.
“CANDOR confirms in a large Phase 3 study the benefit for patients demonstrated in the earlier Phase 1 study using the same combination.”
Amgen intends to submit the data from the CANDOR clinical trial to a future medical meeting and discuss them with health authorities as part of the preparation for regulatory submissions.
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