Bristol-Myers Squibb, AbbVie's Empliciti approved in Europe for multiple myeloma

Bristol-Myers Squibb and AbbVie announced Wednesday that the European Commission authorised Empliciti (elotuzumab) in combination with Celgene's Revlimid (lenalidomide) and dexamethasone for use in adults with multiple myeloma who received at least one prior therapy. The approval was supported in part by data from the Phase III ELOQUENT-2 study, which compared Empliciti in combination with Revlimid and dexamethasone to Revlimid and dexamethasone alone. The drugmakers noted that Empliciti "is now the first and only immunostimulatory antibody approved for multiple myeloma in the European Union."

In the ELOQUENT-2 trial, the results of which were unveiled in May 2015, 646 patients who had received one to three prior therapies were randomised to treatment with Empliciti plus Revlimid and dexamethasone or Revlimid and dexamethasone alone. The co-primary endpoints of the study were progression-free survival (PFS), as assessed using hazard ratios, and overall response rates (ORRs), as determined by a blinded Independent Review Committee using the European Group for Blood and Marrow Transplantation response criteria.

Study results showed that Empliciti in combination with Revlimid and dexamethasone was associated with a 53 percent relative improvement in progression-free survival (PFS) at three years compared to Revlimid and dexamethasone alone, while a trend in favour of an overall survival (OS) benefit was also observed for the triple regimen. The companies noted however that at the time of the interim analysis, the OS endpoint had not reached the pre-determined threshold for statistical significance. The triple regimen was also linked to 21 percent and 50 percent relative improvements in PFS rate at one and two years, respectively, while a significant improvement in ORR of 78.5 percent was seen in the triple regimen arm, compared to 65.5 percent for Revlimid plus dexamethasone.

Empliciti, which specifically targets the cell-surface glycoprotein signalling lymphocyte activation molecule family member 7, was granted accelerated assessment in July last year by the European Medicines Agency (EMA). The therapy was cleared last November for the treatment of multiple myeloma in treatment-experienced patients in the US where it was awarded breakthrough therapy status. 

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