Amgen and Onyx announced results from the Phase 3 ASPIRE trial, which assessed Kyprolis (carfilzomib) for Injection plus Revlimid (lenalidomide) and dexamethasone vs. Revlimid (lenalidomide; Celgene) and dexamethasone in patients with relapsed multiple myeloma.
The ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial achieved its primary endpoint by showing that Kyprolis plus Revlimid and dexamethasone significantly extended the progression-free survival (PFS) by 26.3 months vs. 17.6 months with Revlimid and dexamethasone (HR 0.69, 95% CI 0.57–0.83; P<0.0001).
Secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DOR), health-related quality of life (HR-QoL) measures and safety. The ORR was 87.1% with Kyprolis plus Revlimid and dexamethasone and 66.7% with Revlimid and dexamethasone (P<0.0001). Complete response was achieved in 14% of the Kyprolis plus Revlimid and dexamethasone showed a 14% vs. 4.3% of patients in the Revlimid and dexamethasone group.
Results from the ASPIRE trial will support the regulatory submissions beginning in the first half of 2015.
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