ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) was a Phase 3 trial that evaluated the triplet regimen Kyprolis, lenalidomide, and dexamethasone (KRd) vs lenalidomide and dexamethasone (Rd) alone, in patients with relapsed or refractory multiple myeloma who received 1-3 prior regimens.
VMP consists of Velcade, a proteasome inhibitor (PI); melphalan, an alkylating agent; and prednisone, a steroid.
Kyprolis and dexamethasone reduced the risk of death by 21% and increased overall survival by 7.6 months.
The approval is based on data from the pivotal Phase 3 ‘482 study, the largest international multiple myeloma clinical trial ever conducted.
The FDA will continue to monitor outcomes from other multiple myeloma clinical trials of Keytruda (KEYNOTE-023 Cohort 1), other PD-1/PD-L1 cancer drugs, and other combinations.
Adverse events seen in these trials were similar to those previously described in the lenalidomide product labeling.
