options. We look forward to presenting our findings at CTOS and initiating a rolling Biologics License Application for lete-cel in 2025 for the treatment of both synovial sarcoma and MRCLS, building on the potential of our sarcoma franchise.”
The primary analysis includes data from 64 people with synovial sarcoma or MRCLS who received lete-cel manufactured with the proposed commercial manufacturing process in the IGNYTE-ESO trial. In the analysis, 27/64 (42%) people with synovial sarcoma or MRCLS had RECISTv1.1 responses by independent review, with six 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, -). The median progression free survival (PFS) was 5.3 months (95% CI 4.0, 8.0).
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.
CTOS presentation details:
| ● | Title: Planned Analysis of the Pivotal IGNYTE-ESO Trial of Lete-Cel in Patients with Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (Paper 84) |
| ● | Session 12: Immunology: Podium presentation |
| ● | Presenter: Sandra D’Angelo, MD, Sarcoma Medical Oncologist and Cell Therapist, Memorial Sloan Kettering Cancer Center |
| ● | Date/Time: Saturday, November 16, 10:30 AM - 12:00 PM PT / 1:30 - 3:00 PM ET |
Adaptimmune virtual KOL event November 18th
Adaptimmune will host a virtual event to discuss and review the IGNYTE-ESO dataset and the impact of engineered cell therapies on the treatment landscape in sarcoma. The event will feature Sandra D’Angelo, M.D., Sarcoma Medical Oncology, Memorial Sloan Kettering Cancer Center, an investigative clinician in both the SPEARHEAD and IGNYTE-ESO clinical trials, and author and presenter of the IGNYTE-ESO data update at CTOS. A live question and answer session will follow the formal presentation. The virtual event will take place on Monday, November 18, 2024 from 2:30 PM ET to 3:30 PM ET. To register, click here.
About the IGNYTE-ESO trial
IGNYTE-ESO is a pivotal, Phase 2, open-label trial for people with previously treated, advanced synovial sarcoma or MRCLS to evaluate the efficacy, safety, and tolerability of lete-cel. Lete-cel's engineered TCR T-cells target NY-ESO-1+ tumors. NY-ESO-1 is a solid tumor antigen highly expressed in synovial sarcoma and MRCLS.