The FDA has issued a ‘safe to proceed’ for the investigational new drug application enabling a phase 1 study evaluating NY-ESO-1 TCR/IL-15 NK, a first-in-class engineered T-cell receptor natural killer cell therapy for patients with relapsed/refractory multiple myeloma.
The combination of daratumumab, ixazomib, and dexamethasone produced rapid and encouraging responses rates following lenalidomide–based therapy in patients with relapsed/refractory multiple myeloma, according to findings from the final analysis of the phase 2 DARIA trial.