Amgen recently reported the overall survival (OS) interim analysis of the Phase 3 head-to-head Endeavor trial delivered positive results.
The study met the key secondary endpoint of OS. In it, patients with relapsed or refractory multiple myeloma lived 7.6 months longer when treated with Kyprolis and dexamethasone rather than Velcade and dexamethasone.
"For an incurable disease like multiple myeloma, a major treatment goal for oncologists and hematologists is to help patients live as long as possible," study co-author and investigator Dr. Meletios Dimopoulos, professor of Clinical Therapeutics at the University of Athens School of Medicine, said. "Based on these data, we now know that Kyprolis not only significantly extended progression-free survival compared to Velcade, but also overall survival, making it a clinically meaningful advance in the treatment of relapsed or refractory multiple myeloma."
The company detailed the results at the 16th International Myeloma Workshop in New Delhi in March. Amgen plans to submit the results to regulatory agencies.
"These results confirm the superiority of Kyprolis over Velcade in relapsed or refractory multiple myeloma patients," Dr. Sean Harper, Amgen's executive vice president of Research and Development, said. "A survival benefit has rarely been demonstrated in relapsed or refractory multiple myeloma. Endeavor is the only study to demonstrate a survival benefit in a head-to-head comparison with a current standard of care regimen. These results further support Kyprolis as a foundational therapy in this patient population."