TOPLINE RESULTS of the phase III ARROW trial (ClinicalTrials.gov identifier NCT02412878) were recently announced by Amgen. The study showed carfilzomib (Kyprolis) administered once weekly at 70 mg/m2 with dexamethasone allowed patients with relapsed or refractory multiple myeloma to live 3.6 months longer without their disease worsening than carfilzomib administered twice weekly at 27 mg/m2 with dexamethasone. The overall safety profile of the once-weekly carfilzomib regimen was comparable to that of the twice-weekly regimen.
The study included 478 patients with relapsed or refractory multiple myeloma who received 2 or 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Patients in the trial treated with the once-weekly carfilzomib regimen achieved a statistically significant superior progression-free survival, with a median of 11.2 months compared to 7.6 months for those treated with the twice-weekly carfilzomib regimen (hazard ratio = 0.69, 95% confidence interval = 0.54–0.88).
The most frequently reported treatment-emergent adverse events (≥ 20%) in either treatment arm were anemia, diarrhea, fatigue, hypertension, insomnia, and pyrexia.
More About ARROW
THE ARROW TRIAL evaluated 478 patients with relapsed or refractory multiple myeloma. Those included in the study were randomized to receive once-weekly carfilzomib (20 mg/m2 on day 1 of cycle 1; 70 mg/m2 on days 8 and 15 of cycle 1; and 70 mg/m2 on days 1, 8, and 15 of subsequent cycles) with dexamethasone (40 mg) vs twice-weekly carfilzomib (20 mg/m2 on days 1 and 2 of cycle 1; 27 mg/m2 on days 8, 9, 15, and 16 of cycle 1; and 27 mg/m2 on days 1, 2, 8, 9, 15, and 16 of subsequent cycles) with dexamethasone (40 mg).
The primary endpoint of the trial was progression-free survival, defined as the time from randomization to disease progression or death. Secondary endpoints included overall response rate, overall survival, and safety and tolerability.
The trial was conducted in approximately 100 sites worldwide. ■