Carfilzomib, lenalidomide, and dexamethasone (KRd) versus bortezomib, lenalidomide, and dexamethasone (VRd) for initial therapy of newly diagnosed multiple myeloma (NDMM): Results of ENDURANCE (E1A11) phase III trial.
Abstract No : LBA1
Abstract Type : Plenary Session, Sun, 1:00 PM-4:00 PM
Indication : Multiple Myeloma
Intervention : Carfilzomib, lenalidomide, dexamethasone (KRd) versus bortezomib, lenalidomide, dexamethasone (VRd)
Company : U.S. National Institutes of Health
Technology : Small molecule
The study accrued 1087 pts (VRd=542, KRd=545). The median age was 65y. Treatment, efficacy, and toxicity data are in the table. At the second of 3 planned interim analyses, with PFS HR=1.04 (95% CI, 0.8 to 1.3, p=0.74), futility was met. Median PFS was VRd=34.4m and KRd=34.6m; no differences were seen based on age (,65 or $65), presence or absence of t(4;14) or ISS stage. The three-year OS (95% CI) was similar: VRd 84% (80 to 88) and KRd 86% (82 to 89).
In this randomized phase 3 trial, KRd did not improve PFS compared with VRd in NDMM. A significantly higher rate of cardio-pulmonary and renal toxicity was observed with KRd, while neuropathy rates were higher with VRd. VRd remains the standard triplet induction regimen in standard and intermediate-risk NDMM, and a suitable backbone for four-drug combinations.
Results could be Set back for the future development of this combination in MM.