Adaptimmune Therapeutics announced positive primary analysis data from its pivotal Phase 2 IGNYTE-ESO trial of lete-cel in people with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS). The trial met its primary endpoint, demonstrating a 42% overall response rate (ORR) among 64 patients treated with lete-cel. This included six complete responses and 21 partial responses, indicating significant clinical activity in these advanced or metastatic solid tumors.
Based on these positive data, Adaptimmune plans to initiate a rolling Biologics License Application (BLA) submission for lete-cel for the treatment of advanced or metastatic synovial sarcoma and MRCLS by the end of 2025. Lete-cel is expected to bolster Adaptimmune's sarcoma franchise by expanding the addressable patient population to include NY-ESO-1 positive synovial sarcoma and MRCLS solid tumors.
The median duration of response (DoR) was 12.2 months overall, with 18.3 months for people with synovial sarcoma and 12.2 months for MRCLS. Safety findings were consistent with the known profile of lete-cel, with manageable toxicities such as cytopenias, cytokine release syndrome (CRS), and rash being the most common adverse events.
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