Amgen’s Kyprolis + Darzalex combo shows progression-free survival benefit in multiple myeloma

pharmafile | September 16, 2019 | News story | Research and Development, Sales and Marketing Amgen, Kyrpolis, darzalex, multiple myeloma, pharma 

Amgen has revealed new Phase 3 data for the combination of Kyprolis (carfilzomib) and Darzalex (daratumumab) in addition to the steroid dexamethasone, showing that the combo met its primary endpoint of progression-free survival (PFS) in the treatment of multiple myeloma (MM) compared to Kyprolis and dexamethasone alone.

The findings showed that the three-drug regimen reduced the risk of progression or death in patients with relapsed or refractory MM by 37% compared to the two-drug combination. Additionally, median PFS for the two-drug regimen stood at 15.8 months, while the median PFS for the three-drug regimen was not been reached by the cut-off date  of the study.

As a three-drug regimen, the combo presented a higher frequency of adverse events compared to the two-drug regimen, with the most common being thrombocytopenia, anaemia, diarrhoea, hypertension, upper respiratory tract infection, fatigue and dyspnoea.

“While treatment advances have improved outcomes for patients with multiple myeloma, there remains a need for additional therapeutic options for patients who have relapsed,” said Dr Ajai Chari, Associate Professor of Medicine, the Director of Clinical Research in the Multiple Myeloma Program and the Associate Director of Clinical Research at the Mount Sinai Cancer Clinical Trials Office. “Candor confirms in a large Phase 3 study the benefit for patients demonstrated in the earlier Phase 1 study using the same combination.”

Amgen confirmed that it would be presenting the full results at an upcoming medical meeting, as well as submitted to health authorities to secure marketing regulations around the world.

Matt Fellows

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