Amgen announced positive results from a planned overall survival (OS) interim analysis of the Phase 3 head-to-head ENDEAVOR trial. The study met the key secondary endpoint of OS, demonstrating that patients with relapsed or refractory multiple myeloma treated with KYPROLIS (carfilzomib) and dexamethasone (Kd) lived 7.6 months longer than those treated with Velcade (bortezomib) and dexamethasone (Vd) (median OS 47.6 months for Kd versus 40.0 for Vd, HR = 0.79, 95 percent CI, 0.65 – 0.96). This Kd regimen administered with 56 mg/m2 KYPROLIS twice weekly is already approved in the U.S., European Union and other countries based on the primary analysis of progression-free survival (PFS) in the ENDEAVOR study.
“For an incurable disease like multiple myeloma, a major treatment goal for oncologists and hematologists is to help patients live as long as possible,” said study co-author and investigator Meletios A. Dimopoulos, M.D., professor of Clinical Therapeutics at the National and Kapodistrian University of Athens, School of Medicine. “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.”
“These results confirm the superiority of KYPROLIS over Velcade in relapsed or refractory multiple myeloma patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “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.”
Adverse events observed in this updated analysis were consistent with those previously reported for ENDEAVOR. The most common adverse events (greater than or equal to 20 percent) in the KYPROLIS arm were anemia, diarrhea, pyrexia, dyspnea, fatigue, hypertension, cough, insomnia, upper respiratory tract infection, peripheral edema, nausea, bronchitis, asthenia, back pain, thrombocytopenia and headache.
Detailed results will be presented on Saturday, March 4 at 7:30 a.m. IST at the 16th International Myeloma Workshop in New Delhi. Amgen plans to submit these results to regulatory agencies worldwide to support a potential label update to the ENDEAVOR study results.
The KYPROLIS clinical program continues to focus on providing solutions for physicians and patients in treating this frequently relapsing and difficult-to-treat cancer. KYPROLIS is available for patients whose myeloma has relapsed or become resistant to another treatment and continues to be studied in a range of combinations and patient populations.
Filed Under: Drug Discovery