BMS and AbbVie receive positive CHMP opinion for investigational antibody, Empliciti, for the treatment of multiple myeloma

Positive opinion based on reduction in the risk of disease progression or death with Empliciti in combination with standard of care regimen for multiple myeloma demonstrated in ELOQUENT-2 study.

“Today’s positive CHMP recommendation means we are one step closer to offering a new type of treatment for patients in Europe with multiple myeloma who have received at least one prior therapy,” said Michael Giordano, senior vice president, head of Development, Oncology, Bristol-Myers Squibb. “We look forward to the European Commission’s decision and the opportunity to extend our leading Immuno-Oncology science to patients with multiple myeloma.”

The CHMP positive opinion is based on data from the Phase III, open-label ELOQUENT-2 study, which evaluated Empliciti in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone. The results of this trial showed a 30% reduction in the risk of disease progression or death with ERd compared to Rd alone and, at the 2-year time point, ERd delivered a 52% relative improvement in progression-free survival. The most common adverse reactions in ERd and Rd, respectively (>20%) were fatigue (61.6%, 51.7%), diarrhea (46.9%, 36.0%), pyrexia (37.4%, 24.6%), constipation (35.5%, 27.1%), cough (34.3%, 18.9%), peripheral neuropathy (26.7%, 20.8%), nasopharyngitis (24.5%, 19.2%), upper respiratory tract infection (22.6%, 17.4%), decreased appetite (20.8%, 12.6%) and pneumonia (20.1%, 14.2%). These results were published in The New England Journal of Medicine on 2 June 2015.