On March 9, 2020, the following press release was made by Bristol Myers Squibb (comments to follow):
March 09, 2020 06:59 AM Eastern Daylight Time
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb Company (NYSE: BMY) today announced topline results from ELOQUENT-1, a Phase 3, randomized, open-label trial evaluating the combination of Empliciti (elotuzumab) plus Revlimid (lenalidomide) and dexamethasone (ERd), versus Revlimid and dexamethasone alone (Rd), in patients with newly diagnosed, previously untreated multiple myeloma who are transplant ineligible. Both treatments were administered continuously until disease progression. At final analysis, the addition of Empliciti did not show a statistically significant improvement in progression-free survival (PFS), the study’s primary endpoint. The safety profile of ERd was generally consistent with the known profile of Empliciti plus Revlimid and dexamethasone.
This finding was not expected: virtually all triplet versus doublet regimens in myeloma have shown the superiority of triplets (there are rare exceptions). Further, in the relapse setting with a similar trial design (ERd vs Rd), the triplet was easily the superior regimen. As already known, elotuzumab is FDA approved with lenalidomide/dexamethasone (for 1-3 prior therapies) and pomalidomide/dexamethasone (for 2 or more prior therapies). Elotuzumab does not have significant single agent activity. Thus, the only front line monoclonal antibody that has shown significant improvement in clinical efficacy is daratumumab (either with lenalidomide/dexamethasone or bortezomib/melphalan/prednisone-for transplant ineligible patients; or in combination with bortezomib/thalidomide/dexamethasone-for transplant eligible patients). Completely unexpected results!