Adaptimmune Therapeutics announced that letetresgene autoleucel (lete-cel) has been granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of patients with unresectable or metastatic myxoid/round cell liposarcoma (MRCLS). This designation applies to patients who have received prior anthracycline-based chemotherapy, are positive for specific HLA types, and whose tumor expresses the NY-ESO-1 antigen.
The designation was based on positive results from the Phase II IGNYTE-ESO trial, where 42% of people with synovial sarcoma or MRCLS demonstrated RECISTv1.1 responses by independent review. This included six complete responses and 21 partial responses, with a median duration of response of 12.2 months. Adaptimmune previously received Breakthrough Therapy Designation for lete-cel for the treatment of synovial sarcoma in 2016.
Adrian Rawcliffe, Adaptimmune's Chief Executive Officer, stated that this designation highlights lete-cel's potential to address a critical unmet need for MRCLS patients. The company aims to bring lete-cel to market in 2026 for both synovial sarcoma and MRCLS, with plans to initiate a rolling Biologics License Application later in 2025. The Breakthrough Therapy Designation is designed to expedite drug development and review processes, offering incentives such as additional FDA guidance and potential priority review.
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