TBI-1301 Immunotherapy Shows Improvement in Synovial Sarcoma Treatment
TBI-1301 demonstrated superior efficacy compared with standard-of-care treatment in patients with synovial sarcoma. Further research is warranted.
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Immunotherapy with TBI-1301 to target NY-ESO-1-positive tumor cells demonstrated promising results for the treatment of advanced or recurrent synovial sarcoma, according to a study published in Clinical Cancer Research. Eight patients were treated in the phase 1/2 trial (NCT03250325), and the overall response rate (ORR) was 50% (95% CI, 15.7-84.3).1
“Overall, the results of this study generally align with those of previous studies using adoptive 358 transfer of NY-ESO-1 specific TCR engineered T cells for advanced [synovial sarcoma],” study authors wrote. “The efficacy of the treatment, in terms of [objective response rate (ORR)] and [overall survival (OS)], was strongly superior to that of pazopanib [Votrient] and in line with results of other adoptive immunotherapy regimens directed against the NY-ESO-1 antigen that have been previously reported.”1
Patients had advanced or recurrent synovial sarcoma that could not be surgically resected and was resistant to anthracycline-based regimens. Patients were administered a split dose of 5x109 TBI-1301 intravenously for 2 days following pre-treatment cyclophosphamide, which was administered at 750 mg/m2/day for 2 days.2
The phase 1 primary end points were incidence of adverse events (AEs), appearance of replication-competent retrovirus (RCR), appearance of clonality, and blood kinetics of TBI-1301. The phase 2 primary end point was ORR. The phase 1 secondary end points were ORR, progression-free rate (PFR), OS, and progression-free survival (PFS). The phase 2 secondary end points were PFR, PFS, OS, incidence of AEs, appearance of RCR, appearance of clonality, and blood kinetics of TBI-1301.
For safety, all patients experienced AEs, and 7 of 8 patients (87.5%) had adverse drug reactions. No deaths were attributed to AEs. Cytokine release syndrome occurred in 4 of 8 patients (50%), but all patients recovered with treatment.1
To be eligible for the study, patients needed to have histologically confirmed synovial sarcoma, a surgically unresectable tumor, progressing or recurrent synovial sarcoma that has been treated with 1-4 regimens of systemic chemotherapy including anthracycline, a tumor expressing NY-ESO-1, measurable lesions evaluable by RECIST v1.1, an ECOG performance status of 0-2, and no severe damage of the major organs. Patients were excluded from the study if they had any of the following conditions: unstable angina, cardiac infarction, heart failure, uncontrolled diabetes, uncontrolled hypertension, active infection, interstitial pneumonia or lung fibrosis, or active autoimmune disease that requires steroids or immunosuppressive therapy.2
“Additional confirmation, ideally with larger numbers of patients, is needed but this study…is expected to be a promising new strategy for the treatment of [synovial sarcoma],” study authors wrote.1
REFERENCES
1. Kawai A, Ishihara M, Nakamura T, et al. Safety and efficacy of NY-ESO-1 antigen-specific T-cell receptor gene-transduced T lymphocytes in patients with synovial sarcoma: a phase I/II clinical trial. [published online ahead of print, 2023 Oct 4]. Clin Cancer Res. 2023;10.1158/1078-0432.CCR-23-1456. doi:10.1158/1078-0432.CCR-23-1456
2. Study of TBI-1301 (NY-ESO-1 T cell receptor gene transduced autologous T lymphocytes) in patients with synovial sarcoma. ClinicalTrials.gov. Updated June 2, 2022. Accessed October 12, 2023. https://clinicaltrials.gov/study/NCT03250325
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