Carfilzomib (Kyprolis) significantly prolonged overall survival compared with bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma, according to an interim analysis of the ENDEAVOR trial.1
The international, open-label, phase 3, head-to-head study (ClinicalTrials.gov Identifier: NCT01568866) showed that patients with relapsed or refractory treated with carfilzomib plus dexamethasone had a 21% reduced risk of death compared with those who received bortezomib plus dexamethasone (hazard ratio, 0.79; 95% CI, 0.65-0.96). Median overall survival was 47.6 months with carfilzomib vs 40.0 months with bortezomib.
“For an incurable disease like multiple myeloma, a major treatment goal for oncologists and hematologists is to help patients live as long as possible,” investigator Meletios A. Dimopoulos, MD, professor of clinical therapeutics at the National and Kapodistrian University of Athens, School of Medicine, said in a press release. “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 safety profiles of both regimens were consistent with those previously reported for ENDEAVOR. The most frequent adverse events in the carfilzomib-treated patients were anemia, diarrhea, pyrexia, dyspnea, fatigue, hypertension, cough, insomnia, upper respiratory tract infection, peripheral edema, nausea, bronchitis, asthenia, back pain, thrombocytopenia, and headache.
The ENDEAVOR study enrolled 929 patients with multiple myeloma whose disease had relapsed after least 1, but not more than 3, prior regimens. Participants were randomly assigned 1:1 to receive low-dose dexamethasone in combination with carfilzomib or dexamethasone.
“These results confirm the superiority of Kyprolis over Velcade in relapsed or refractory multiple myeloma patients,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a statement. “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.”
Amgen plans to these data to the U.S. Food and Drug Administration to support a potential update to the carfilzomib prescribing information.
Carfilzomib is a proteasome inhibitor that is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy, and as a single agent for the treatment of patients with relapsed or refractory disease who have received at least 1 line of prior therapy.
1. Phase 3 head-to-head trial showed Kyprolis (carfilzomib) significantly improved overall survival compared to Velcade (bortezomib) in relapsed or refractory multiple myeloma patients [news release]. Thousand Oaks, CA: Amgen; February 28, 2017. http://www.amgen.com/media/news-releases/2017/02/phase-3-headtohead-trial-showed-kyprolis-carfilzomib-significantly-improved-overall-survival-compared-to-velcade-bortezomib-in-relapsed-or-refractory-multiple-myeloma-patients/. Accessed March 2, 2017.