Results of ELOQUENT-1 Study miss endpoint

US pharma major Bristol-Myers Squibb (NYSE: BMY) has announced disappointing top-line results from ELOQUENT-1, a Phase III, 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. The company will complete a full evaluation of the ELOQUENT-1 data and work with investigators to present the results at a future medical meeting.

B-MS’s shares were down 7% at $56.51 in pre-market trading, but that was almost certainly due to the massive wider market slump due to the novel coronavirus spread around the world, with the NYSE Composite 6.9% lower before official trading started.