Approval was based on results from ELOQUENT-3, a Phase 2, open-label trial (N=117) involving patients with relapsed or refractory multiple myeloma.
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.
Patients diagnosed with monoclonal gammopathy of undetermined significance (MGUS) and followed for multiple decades showed shorter overall survival rates compared to matched controls.
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.