Adaptimmune Advances Lete-cel Towards FDA Approval with New Sarcoma Study Success

The Phase II IGNYTE-ESO study conducted by Adaptimmune Therapeutics has demonstrated promising results for its investigational cell therapy, lete-cel, targeting patients with advanced synovial sarcoma and myxoid/round cell liposarcoma. This study showed a notable 42% response rate among the 64 participants, with a median response duration of 12.2 months, extending to 18.3 months for those with synovial sarcoma[1][2]. The median progression-free survival clocked in at 5.3 months, while safety profiles indicated manageable adverse effects, thereby supporting the viability of lete-cel as a new therapeutic option[1][2]. These encouraging outcomes have propelled Adaptimmune to commence a rolling Biologics License Application process by the end of 2025, signifying a strategic progression towards seeking FDA approval for this potentially groundbreaking therapy[1][2].