BMS’ ELOQUENT-1 Phase III study fails to meet primary endpoint

9th March 2020 (Last Updated March 9th, 2020 14:33)

Bristol Myers Squibb’s (BMS) ELOQUENT-1 Phase III trial evaluating the Empliciti combination in patients with newly diagnosed, previously untreated multiple myeloma has failed to meet the primary endpoint of progression-free survival (PFS) in patients ineligible for transplant.

BMS’ ELOQUENT-1 Phase III study fails to meet primary endpoint
The primary endpoint of the study was to determine whether the addition of Empliciti to Revlimid and low-dose dexamethasone would improve progression-free survival. Credit: KGH.

Bristol Myers Squibb’s (BMS) ELOQUENT-1 Phase III trial evaluating the Empliciti combination in patients with newly diagnosed, previously untreated multiple myeloma has failed to meet the primary endpoint of progression-free survival (PFS) in patients ineligible for transplant.

The randomised, open-label trial analysed combinations of Empliciti (elotuzumab) plus Revlimid (lenalidomide) and dexamethasone (ERd), versus Revlimid and dexamethasone alone (Rd) in the subjects.

Empliciti is an immunostimulatory antibody that targets a cell-surface glycoprotein called Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7).

The company revealed that the addition of Empliciti did not find a statistically vital improvement in PFS in the final analysis.

Secondary endpoints of the ELOQUENT-1 Phase III trial were objective response rate and overall survival. The safety profile of ERd was observed to be generally consistent with the known profile of Empliciti plus Revlimid and dexamethasone.

Bristol Myers Squibb Hematology Global Clinical Development senior vice-president Noah Berkowitz said: “While we are disappointed that the ELOQUENT-1 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.”

Multiple myeloma is said to be an aggressive disease characterised by relapse and is prone to be refractory to several therapies.

BMS said that it will complete a full evaluation of the ELOQUENT-1 data and work with investigators to present the results at a future medical meeting.

The company is developing Empliciti with US biopharmaceutical company AbbVie.