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Bristol-Myers Empliciti Combo Fails in First-Line Myeloma Study

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Bristol-Myers Squibb Company BMY announced that a phase III ELOQUENT-1 study evaluating Empliciti (elotuzumab) triplet combination in first-line patients with multiple myeloma, who are transplant ineligible, failed to meet its primary endpoint.

The ELOQUENT-1 study compared Empliciti in combination with Revlimid plus dexamethasone (ERd) to a combination of Revlimid and dexamethasone (Rd) in newly diagnosed, previously untreated multiple myeloma patients, who are ineligible for a transplant, for improvement in progression-free survival ("PFS"). Data from the study showed that the ERd combo failed to demonstrate statistically significant improvement in PFS. However, safety profile of the Empliciti triplet combination was consistent with previous clinical studies.

Detailed data from the study will be presented at a future medical meeting.

Please note that ERd combo is already approved for the treatment of relapsed and refractory multiple myeloma (r/rMM) in second or later-line settings. The treatment regimen is also the standard of care in its approved indication. Empliciti is also approved in combination with Pomalyst plus dexamethasone for treating multiple myeloma patients, who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Bristol-Myers co-develops Empliciti in collaboration with AbbVie (ABBV - Free Report) . Bristol-Myers is solely responsible for the drug’s commercialization activities.

Shares of Bristol-Myers have increased 13.3% in the past year against the industry’s decrease of 0.8%.

The drug generated sales of $257 million in 2019, up 44.5% year over year. A successful development as a treatment for first-line multiple myeloma may have further boosted the drug’s prospect. Bristol-Myers is currently evaluating the drug in combination with its blockbuster immuno-oncology drug, Opdivo, in a phase II study as a treatment for r/rMM.

Meanwhile, Bristol-Myers key drug, Opdivo continues to perform well, driven by label expansions. However, the drug faces stiff competition globally from Merck MRK PD-1 inhibitor, Keytruda, and Roche’s RHHBY PD-L1 inhibitor,Tecentriq.

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