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Thomas Flaig, MD
Thomas Flaig, MD
Posted: Friday, June 24, 2022
HaiTao Wang, MD, MS, PhD, of Tianjin Medical University, China, and colleagues aimed to elucidate the efficacy and safety of combining the monoclonal antibody tislelizumab with nab-paclitaxel in patients with non–muscle-invasive urothelial bladder carcinoma. The preliminary data and exploratory work of the phase II TRUCE-02 trial were presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4507).
“Tislelizumab with nab-paclitaxel represents a novel treatment option with a satisfactory benefit in treating non–muscle-invasive bladder cancer,” concluded the study authors. “Whole-genome sequencing results also showed there are mutation markers that may predict whether patients would benefit from this treatment plan.”
This open-label, single-arm study enrolled 54 patients with tumors that were not completely resectable by transurethral resection. Participants who met study criteria received 200 mg of tislelizumab plus 200 mg of nab-paclitaxel for three or four cycles, followed by comprehensive imageology, urine cytology, and pathology assessments.
A total of 42 patients completed the entire three- or four-treatment cycles and reached the primary study endpoint; 23 participants achieved a complete response. With an objective response rate of 60%, 33 individuals have been able to avoid cystectomy thus far. Notably, the rate of grade 3 or 4 adverse events was lower than 2%. Furthermore, urine cytology and fluorescence in situ hybridization demonstrated diagnostic efficiencies of 68.4% and 45.7% before pathologic assessment, respectively.
Regarding PD-L1, 47.3% of patients achieving a complete or partial response and 50% of those who were unresponsive tested positive for PD-L1 expression. In addition, sequencing results uncovered that the protein TCF7L2 may be a potential marker in predicting adverse outcomes for individuals in this population. Also, homologous recombination repair mutations may predict the prognosis of bladder cancer and help to guide therapeutic options.
Disclosure: The study authors reported no conflicts of interest.
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