Bristol-Myers Squibb and AbbVie announced that the FDA has granted Breakthrough Therapy Designation to elotuzumab, for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies.
The designation is based on results from a randomized Phase 2, open-label study that evaluated two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated patients, including the 10mg/kg dose that is being studied in Phase 3 trials.
Elotuzumab is a humanized IgG1 monoclonal antibody targeted against Signaling Lymphocyte Activation Molecule (SLAMF7, also called CS1), a glycoprotein expressed on myeloma and Natural Killer cells but not detectable in normal tissue. Investigation is underway on whether elotuzumab may selectively target and kill SLAMF7 expressing myeloma cells through both direct activation and engagement of Natural Killer cells.
Elotuzumab is being studied as a monotherapy in smoldering myeloma and in combination with other therapies in first-line and relapsed or refractory multiple myeloma. A clinical development program for the agent is underway, including Phase 3 trials in first-line multiple myeloma (ELOQUENT-1) and relapsed or refractory multiple myeloma (ELOQUENT-2). Elotuzumab is also being investigated in a randomized Phase 2 study of bortezomib and dexamethasone in relapsed or refractory multiple myeloma.