Data from a Phase III study showed that the addition of Bristol-Myers Squibb and AbbVie's experimental drug elotuzumab to standard therapy in patients with relapsed or refractory multiple myeloma led to significantly longer remissions and cut the risk of death. Further results from the trial will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO).
The ELOQUENT-2 study randomised 646 patients with recurrent multiple myeloma to receive standard therapy, consisting of the combination of Celgene's Revlimid (lenalidomide) and dexamethasone, or standard therapy plus elotuzumab. Results demonstrated that patients who received elotuzumab lived a median time of 19.4 months until their disease progressed or until they died, compared with 14.9 months in those who received standard therapy alone. In addition, at a median follow-up period of two years, elotuzumab reduced the risk of disease progression or death by 30 percent.
Lead investigator Sagar Lonial noted that although survival data were not yet available, "there clearly are very encouraging signs in terms of overall survival." Commenting on the findings, ASCO president-elect Julie Vose said "this is probably a practice-changing type of treatment," adding "I expect they will get approval."
Specifically, results showed that after two years, disease had not progressed in 41 percent of patients who received elotuzumab, versus 27 percent of patients given standard therapy. Meanwhile, at one year, the figures were 68 percent and 57 percent, respectively, in the two groups. "It was particularly striking that the difference...seems to get bigger over time," Lonial remarked, adding that this "really speaks to the power of this immune-based approach." Data indicated that the addition of elotuzumab did not lead to a significant increase in adverse side effects or toxicity.
Elotuzumab, which targets the SLAMF7 glycoprotein, received  breakthrough therapy designation from the FDA last year for use in combination with Revlimid and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior treatments. Bristol-Myers Squibb and AbbVie are also evaluating elotuzumab in patients with newly diagnosed multiple myeloma.