Adaptimmune to Present Interim IGNYTE-ESO Trial Data at ASCO, Supporting Sarcoma Franchise Development

Adaptimmune Therapeutics plc, a company focused on innovative cell therapies for treating solid tumor cancers, recently presented data from its pivotal IGNYTE-ESO trial at the American Society of Clinical Oncology's (ASCO) annual meeting. The trial investigates lete-cel (letetresgene autoleucel), an engineered cell therapy targeting the NY-ESO-1 antigen, in patients with synovial sarcoma (SyS) and myxoid/round cell liposarcoma (MRCLS).

Dr. Sandra D’Angelo from Memorial Sloan Kettering Cancer Center presented the interim findings, which demonstrated a 40% overall response rate (ORR) across both sarcoma types. The median duration of response (mDOR) was approximately 11 months, with many patients still responding at the time of analysis. These results significantly surpass the historical outcomes typically seen with standard care in these conditions.

Dennis Williams, PharmD., Senior Vice President of Late-Stage Development at Adaptimmune, expressed optimism about the findings, highlighting the potential of lete-cel to expand Adaptimmune’s sarcoma treatment portfolio. The company’s other leading cell therapy product, afami-cel, targets the MAGE-A4 antigen in synovial sarcoma. Williams stated that the ability to target NY-ESO-1 with lete-cel could allow Adaptimmune to reach more patients afflicted by advanced sarcomas. The company aims to commercialize afami-cel later this year and plans to launch lete-cel in 2026.

Dr. Sandra D’Angelo emphasized the significance of the data, noting that current treatment options for advanced MRCLS and synovial sarcoma are limited. The promising results of lete-cel offer a potential new therapeutic avenue for these patients.

The interim analysis involved 45 patients who received a single dose of lete-cel, with 18 showing clinical responses. The consistent 40% ORR across both sarcoma types met the primary endpoint for efficacy. The durability of these responses, with an mDOR of around 11 months, is notable, and further results are anticipated as the dataset matures.

Adaptimmune aims to submit a rolling Biologics License Application (BLA) for lete-cel in 2025 for the treatment of advanced MRCLS and synovial sarcoma. The successful outcomes from the IGNYTE-ESO trial position lete-cel to enhance Adaptimmune’s sarcoma franchise, potentially extending its reach to patients with NY-ESO-1 positive tumors.

Lete-cel, an engineered TCR T-cell therapy, aims to treat solid tumors by targeting the NY-ESO-1 antigen. The IGNYTE-ESO trial focuses on patients with synovial sarcoma and MRCLS who have previously undergone anthracycline treatment.

Synovial sarcoma, a type of soft tissue sarcoma, accounts for 5% to 10% of all such sarcomas, with about 13,400 new cases annually in the U.S. It often affects younger patients, with one-third diagnosed before age 30. The five-year survival rate for metastatic cases is just 20%, and patients frequently face recurrence after exhausting standard treatment options.

Myxoid/round cell liposarcoma (MRCLS) also represents 5% to 10% of soft tissue sarcomas and typically occurs in the limbs. Around one-third of MRCLS cases become metastatic, spreading to unusual bone and soft tissue sites. The prognosis for metastatic MRCLS is poor, with a five-year survival rate of only 5%.

Adaptimmune is committed to redefining cancer treatment through its unique engineered T cell receptor (TCR) platform. The company's goal is to develop personalized medicines that target and destroy challenging solid tumors, aiming to significantly improve the patient treatment experience.