A Phase III clinical trial testing a drug from Bristol-Myers Squibb and AbbVie for multiple myeloma has failed, BMS said Monday.
The New York-based drugmaker said that the Phase III ELOQUENT-1 study of Empliciti (elotuzumab) and Revlimid (lenalidomide) with the steroid dexamethasone had not met its primary endpoint of extending the length of time patients with newly diagnosed disease who are ineligible for bone marrow transplant live without their disease worsening, known as progression-free survival, or PFS. The three-drug combination was compared against Revlimid and dexamethasone alone.
Empliciti, a monoclonal antibody that targets the antigen SLAMF7, is approved for combination with Revlimid and dexamethasone for multiple myeloma patients who have received one to three prior therapies. It is also approved for combination with Pomalyst (pomalidomide) and dexamethasone in patients who have received at least two prior therapies that include Revlimid and a proteasome inhibitor. BMS acquired control of Revlimid and Pomalyst when it bought their manufacturer, Celgene, last year. It is co-developing Empliciti with Chicago-based AbbVie and is solely responsible for commercializing the drug.
“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 relapsed/refractory multiple myeloma, providing the potential for improved survival in this population of patients who are in need of additional treatment options,” BMS senior vice president for global clinical development in hematology Noah Berkowitz said in a statement.
Empliciti has nevertheless not kept pace on the market with other drugs approved for multiple myeloma that have grown to become regarded as “backbone” treatments. These include Revlimid, proteasome inhibitors like Takeda Pharmaceutical’s Velcade (bortezomib), as well as CD38-targeting monoclonal antibodies like Johnson & Johnson’s Darzalex (daratumumab) and Sanofi’s newly approved Sarclisa (isatuximab-irfc). Empliciti had global sales of $357 million in 2019, compared with $1.3 billion for Revlimid, according to BMS’ latest annual earnings report, though that drug will lose patent protection in the near future. Darzalex’s global sales were nearly $3 billion, according to J&J.
BMS is developing additional therapies for multiple myeloma, most notably idecabtagene vicleucel, a CAR-T cell therapy that targets the antigen BCMA, under a partnership with bluebird bio. It also has an antibody-drug conjugate, CC-99712, with the same antigen target. GlaxoSmithKline recently filed for Food and Drug Administration approval of its own BCMA-targeting antibody-drug conjugate, balantamab mafodotin.
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