The US FDA recently approved use of elotuzumab with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
A related Perspective discusses immunotherapy combinations in multiple myeloma, with a focus on the FDA mandated labelling changes in November 2017 for pembrolizumab and the thalidomide-analogue immunomodulatory agents to include information regarding increased mortality observed in two randomized trials of pembrolizumab with an immunomodulatory agent (lenalidomide or pomalidomide) and dexamethasone in patients with multiple myeloma. The FDA had also placed approximately 30 clinical trials investigating these combinations on hold and issued a safety alert. The Perspective notes that “combination-drug development using cytotoxic drugs has been ongoing in oncology since the 1960s, and curative multidrug regimens have been established for both hematologic and solid-tumor cancers. These regimens have generally been created by combining drugs with known activity against a disease. This experience in multiple myeloma sounds a cautionary note: combination immunotherapy may not follow the cytotoxic-drug paradigm. How a combination’s components interact in a complex immunologic tumor microenvironment will need to be thoroughly investigated.”