Lifileucel/LN-145 (autologous TIL) posts 11% ORR and 76% DCR in R/M HNSCC

One-time autologous tumor-infiltrating lymphocyte (TIL) therapy—cryopreserved lifileucel (22- vs 16-day manufacturing) and a PD-1–selected TIL product (LN-145-S1)—was given after non-myeloablative lymphodepletion with IL-2 in the Phase 2 C-145-03 study (NCT03083873) of recurrent/metastatic HNSCC: 53 treated patients (median age 57; median 2 prior lines; 87% prior PD-1/PD-L1). Investigator-assessed ORR was 11% (6/53; all PRs), disease control was 76% (64% SD), and median DOR was 7.6 mo at 17.9-mo follow-up; safety matched expected lymphodepletion/IL-2 toxicities with no new signals. In contemporary post-ICI salvage care, chemotherapy often achieves higher response rates—overall ORR ≈49% (up to ≈68% with cetuximab-based regimens), with mPFS ≈4.1 mo and mOS ≈9.3 mo—underscoring that single-infusion TIL monotherapy brings lower ORR despite some durable control.