Engineered TIL Cell Therapy Fast Tracked for Advanced Melanoma
Source: Medical Professionals Reference, July 2024
The Food and Drug Administration (FDA) has granted Fast Track designation to OBX-115 for the treatment of metastatic, or locally advanced melanoma that is refractory to, or has relapsed after programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1)–based immune checkpoint inhibitors (ICI).
The designation is supported by data from an ongoing, single-center phase 1 study (ClinicalTrials.gov Identifier: NCT05470283) evaluating the safety and efficacy of OBX-115, an interleukin 2-sparing engineered tumor-infiltrating lymphocyte (TIL) cell therapy, in combination with acetazolamide in patients with advanced or metastatic melanoma who were previously treated with ICIs.
Results showed all 10 infused patients were alive at data cutoff of April 4, 2024 (median follow-up of 29.5 weeks). The objective response rate was 44%, with 2 patients achieving complete response.