Bristol Myers Squibb "disappointed" with failed late-stage combo drug trial

9 Mar 2020

Phase III study evaluating Empliciti plus Revlimid and dexamethasone in patients with newly diagnosed, untreated multiple myeloma fails to meet primary endpoint.

Bristol Myers Squibb has revealed results from 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.

Bristol Myers Squibb disappointed with failed late-stage combo drug trial

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 trial's data and work with investigators to present the results at a future medical meeting.

Commenting on the results, Noah Berkowitz, senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb, said: "While we are disappointed that the trial did not meet its primary endpoint in these previously untreated, transplant-ineligible patients, the Empliciti, Revlimid and dexamethasone combination remains a standard treatment for patients with relapsed/refractory multiple myeloma, providing the potential for improved survival in this population of patients who are in need of additional treatment options."

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