Once weekly Kyprolis shows superior PFS and OS response rates over twice weekly Kyprolis treatment of multiple myeloma in A.R.R.O.W.study- Amgen.
Amgen has announced results from the Phase III A.R.R.O.W. trial of a once-weekly Kyprolis (carfilzomib) dosing regimen in patients with relapsed and refractory multiple myeloma . In the trial, Kyprolis administered once-weekly at 70 mg/m2 with dexamethasone (once-weekly Kd) achieved superior progression-free survival (PFS) and overall response rates (ORR), with a comparable safety profile, versus twice-weekly Kyprolis at 27 mg/m2 and dexamethasone (twice-weekly Kd). These data were presented during an oral session at the 54th Annual Meeting of the American Society of Clinical Oncology ( ASCO ) and simultaneously published in The Lancet Oncology.
A.R.R.O.W. included 478 patients with relapsed and refractory multiple myeloma who received two or three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent (IMiD). Patients in the trial treated with once-weekly Kd achieved a statistically significant 3.6 month improvement in PFS compared to the twice-weekly regimen (median PFS 11.2 months for once-weekly Kd versus 7.6 months for twice-weekly Kd; HR=0.69; 95 percent CI: 0.54-0.88; one-sided p=0.0014).The ORR in patients treated with once-weekly Kd was 62.9 percent versus 40.8 percent for those treated with the twice-weekly regimen (p<0.0001). In addition, 7.1 percent had complete responses or better in the once-weekly arm versus 1.7 percent in the twice-weekly arm in this refractory patient population. The overall safety profiles of the two arms were comparable, with no new safety risks identified in the once-weekly arm. The most frequently reported treatment-emergent adverse events (greater than or equal to 20 percent) in either treatment arm were anemia, diarrhea, fatigue, hypertension, insomnia and pyrexia.
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