FDA Grants Breakthrough for Letetresgene
Adaptimmune Therapeutics plc 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) who have received prior anthracycline-based chemotherapy, are positive for HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06, and whose tumor expresses the NY-ESO-1 antigen
More details about the Company's sarcoma franchise, including the lete-cel clinical program and launch progress for Telcera (afamitresgene autoleucel), the Company's first commercial product and the first FDA approved engineered cell therapy for a solid tumor, will be provided during the Company's presentation at the Annual J.P. Morgan Healthcare Conference, taking place in San Francisco, California, on Tuesday, January 14th, 2025, 4:30-5:10 PM PST
Breakthrough therapy designation for lete-cel in MRCLS was based on the results in this indication from the Phase II IGNYTE-ESO trial. The Company previously received breakthrough therapy designation for lete-cel for the treatment of synovial sarcoma in 2016. In the Phase II analysis, 27/64 (42%) people with synovial sarcoma or MRCLS had RECISTv1.1 responses by independent review, with 6 complete responses and 21 partial responses. The response rate was 14/34 (41%) for people with synovial sarcoma and 13/30 (43%) for people with MRCLS. The median duration of response (DoR) was 12.2 months (95% CI 6.8, 19.5). In synovial sarcoma, the median duration of response was 18.3 months (95% CI 3.3, -). In MRCLS, the median duration of response was 12.2 months (95%, CI 5.3, -). Safety findings were consistent with the known profile of lete-cel from previous data. All patients experienced treatment-emergent adverse events: cytopenias, cytokine release syndrome (CRS) and rash were the most common adverse events. Overall, toxicities were manageable, and consistent with an acceptable benefit to risk profile. Data from this trial were presented at the Connective Tissue Oncology Society (CTOS) 2024 annual meeting
Adrian Rawcliffe, Adaptimmune's Chief Executive Officer: said "This designation by the FDA highlights the potential of lete-cel to address a critical need for new treatment options for patients with MRCLS. This is another important milestone in building out our sarcoma franchise, as we aim to bring lete-cel to market in 2026 for the treatment of synovial sarcoma and MRCLS. We look forward to initiating a rolling Biologics License Application for lete-cel later this year for the treatment of both sarcoma indications."
In addition to the Company's presentation at J.P. Morgan, Adaptimmune will present the Company's Allo-T program as a spin-out opportunity at the Biotech ShowCase and the Wuxi Global Forum 2025 Investor Roundtable. Details are as follows:1) Biotech Showcase | Investor conference | Co-produced by Demy-Colton and EBD Group Presentation at 2 p.m. PST on Tuesday, January 14th, Yosemite C, Hilton Hotel, Union Square.2) WuXi Global Forum 2025 - WXPress: for WuXi news and R&D insights Round Table Presentation at 5 p.m. PST on Tuesday, January 14th, Tower 3, Hilton Hotel, Union Square
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