publication date: Jul. 24, 2015
Kyprolis Combination Approved in Relapsed Multiple Myeloma
FDA approved Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. Kyprolis is sponsored by Onyx Pharmaceuticals Inc., an Amgen subsidiary.
The approval was based on a demonstration of improved progression-free survival in a multicenter, open-label trial (PX-171-009 ASPIRE). The trial enrolled 792 patients with relapsed or refractory multiple myeloma after one to three lines of prior therapies. The patients were randomized to receive lenalidomide and dexamethasone with or without Kyprolis for 18 cycles. Lenalidomide and dexamethasone were continued thereafter until disease progression. There was no planned cross-over from the control arm to treatment with Kyprolis.
A statistically significant prolongation of PFS, as determined by an independent review committee, was demonstrated [HR 0.69 (95% CI: 0.57, 0.83); p = 0.0001, stratified log-rank test].
Median PFS was 26.3 months in the Kyprolis arm and 17.6 months in the two-drug arm. A treatment effect was observed across all subgroups tested, but the magnitude of the treatment effect was reduced in patients with higher tumor burden at study baseline (improvement in median PFS: 11 months for ISS Stage I, 8 months for ISS Stage II and 2 months for ISS Stage III).
An interim analysis of overall survival was conducted at the same time. The difference in OS did not reach the prespecified boundary for statistical significance. A partial response or better was achieved by 87 percent of patients on the Kyprolis arm and 67 percent on the two-drug arm.
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