T-cell receptor therapy safe, effective for soft tissue sarcoma
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CHICAGO — A novel T-cell receptor therapy showed promising antitumor activity in patients with advanced soft tissue sarcoma, according to results from a phase 1 study presented at ASCO Annual Meeting.
Investigators said early data from the study suggest the treatment is safe and tolerable.
Background
TAEST16001 is an investigational autologous T-cell therapy genetically engineered to express a high-affinity T-cell receptor that targets the cancer-testis antigen NY-ESO-1.
“Soft tissue sarcoma is known to express high levels of NY-ESO-1, making it a promising target for this novel cellular therapy,” Xing Zhang, MD, PhD, of the Melanoma and Sarcoma Medical Oncology Unit at Sun Yat-sen University Cancer Center, said during a presentation.
Methodology
Zhang and colleagues enrolled 12 patients (mean age, 37.9 years; 7 men, 5 women) in a single-arm dose-escalation/dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of TAEST16001 in patients with advanced unresectable soft tissue sarcoma. The study included HLA-A*02:01-positive patients with soft tissue sarcoma expressing NY-ESO-1.
Participants underwent lymphodepleting chemotherapy followed by infusion with TAEST16001. Patients received one of four cumulative dose levels: 5 × 108 ± 30% (dose level 1), 2 × 109 ± 30% (dose level 2), 5 × 109 ± 30% (dose level 3) or 1.2 × 1010 ± 30% (dose level 4/expansion) cells/patient.
All patients received subcutaneous interleukin-2 injections for 14 days after the cell therapy infusion to promote activation of the modified T cells.
Key findings
The maximum tolerated dose of TAEST16001 was not reached, and the investigators reported no dose limiting toxicities.
The most frequently reported treatment-related adverse events were hematologic in nature, including grade 3 lymphopenia in 11 patients (92%).
Two patients (17%) developed grade 2 cytokine release syndrome that resolved after standard treatment. No cases of treatment-related neurotoxicity or infusion-related adverse events occurred.
Investigators reported a 41.7% overall response rate, including five patients with a partial response to therapy and five with stable disease. The remaining two patients experienced disease progression.
The researchers observed a disease control rate of 83.3%.
Further analysis showed a median duration of response of 14.1 months (range, 5 to 14.2).
Clinical implications
“TAEST16001 cells showed an acceptable safety profile, and a single infusion of this therapy resulted in durable responses in patients with soft tissue sarcoma,” Zhang said. “A phase 2 study is encouraged due to the emerging efficacy data in this phase 1 trial.”
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Zhang X, et al. Abstract 11502. Presented at: ASCO Annual Meeting; June 3-7, 2022; Chicago.
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