A higher dose of carfilzomib administered once weekly prolonged progression-free survival (PFS) among patients with relapsed or refractory (R/R) multiple myeloma (MM) by 3.6 months compared with twice-weekly administration of a lower dose, according to results from an interim analysis noted in a press release.1
In the phase 3 ARROW study (ClinicalTrials.gov Identifier: NCT02412878), researchers randomly assigned 478 patients with R/R MM to receive carfilzomib 70 mg/m2 once weekly plus dexamethasone or carfilzomib 27 mg/m2 twice weekly plus dexamethasone. Study patients must have received at least 2, but no more than 3, prior treatments, including bortezomib and an immunomodulatory agent.
The primary outcome of the study is PFS; secondary outcomes include overall response rate, overall survival, safety, and tolerability.
Patients receiving carfilzomib once weekly had a significantly superior PFS of 11.2 months vs 7.6 months for patients receiving the drug twice weekly (hazard ratio [HR], 0.69; 95% CI, 0.54-0.88).
The treatment arms had comparable safety profiles. The most frequently reported adverse events included anemia, diarrhea, fatigue, insomnia, hypertension, and pyrexia.
MM is an incurable hematologic cancer defined as the formation of malignant plasma cells in the bone marrow. The disease is characterized by a recurring pattern of remission and relapse. MM accounts for 0.7% of all diagnosed cancers and approximately 13,000 deaths annually in the US.
- Phase 3 A.R.R.O.W. study of once-weekly Kyprolis (carfilzomib) regimen meets primary endpoint of progression-free survival in relapsed and refractory multiple myeloma patients [news release]. Thousand Oaks, CA: PRNewswire; October 23, 2017. https://www.prnewswire.com/news-releases/phase-3-arrow-study-of-once-weekly-kyprolis-carfilzomib-regimen-meets-primary-endpoint-of-progression-free-survival-in-relapsed-and-refractory-multiple-myeloma-patients-300541392.html. Accessed October 24, 2017.