Elotuzumab combo granted FDA priority review

Bristol-Myers Squibb’s multiple myeloma (MM) drug, elotuzumab (Empliciti), has been granted Priority Review by the US Food and Drug Administration (US FDA), for use in combination with pomalidomide and low-dose dexamethasone. This will benefit patients that have received two or more prior therapies, including lenalidomide and a proteasome inhibitor (PI).

The supplemental biologics license application (sBLA) was based on data from the phase II ELOQUENT-3 study, which was presented by Professor Meletios Dimopoulos at the 23rd Congress of the European Hematology Association (EHA) that took place in Stockholm from 14–17 June 2018 – details of the study can be found here. Notably, treatment with elotuzumab plus pomalidomide and dexamethasone led to a 46% reduction in risk of progression or death, compared to patients treated with pomalidomide and dexamethasone alone. Importantly, this study included 87% of patients that were refractory to lenalidomide (len). Given how frequently lenalidomide is found in many of the treatment combos, this will now offer a valuable alternative for patients that are refractory to len. Adverse Events (AEs) were minimal, with infusion reactions the only major elotuzumab-related complaint, although these were easily managed.

Elotuzumab is a humanized monoclonal antibody against SLAMF7 (Signaling Lymphocyte Activation Molecule Family member 7), a cell- surface glycoprotein highly expressed on myeloma cells but not on healthy cells, with the exception of NK cells. Engagement of SLAMF7 on NK cells drives immune activation, whilst engagement on myeloma cells tags them for destruction.

Although the progress of elotuzumab in the pipeline has been slow compared to many other drugs, this latest development will be welcome news for patients and physicians alike, offering yet another viable treatment option for patients with relapsed and refractory disease. A final decision from the FDA is expected on 27 December 2018.