Bristol-Myers Squibb/AbbVie’s experimental monoclonal antibody elotuzumab has turned in impressive interim Phase III data showing increased progression-free survival in patients with relapsed/refractory multiple myeloma.
According to early data from the 646-patient ELOQUENT-2 trial, adding elotuzumab to therapy with Revlimid (lenalidomide) and dexamethasone cut the risk of disease progression by 30% and extended remission by 4.5 months.
Results taken at two-year follow-up showed that PFS in patients given the elotuzumab-based therapy regimen was 19.4 months compared to 14.9 months in the control arm, while one-year PFS was 68% versus 57%, and two-year PFS 41% vs 27%, respectively.
The findings have raised hopes that the drug is well on track for a regulatory nod. Reuters quoted ASCO president-elect Julie Vose as saying: “this is probably a practice-changing type of treatment…I expect they will get approval."
Elotuzumab picked up breakthrough therapy designation in the US last year for use alongside Revlimid and dexamethasone in multiple myeloma patients who have received one or more prior therapies, and is the first monoclonal antibody targeting the disease.