Tislelizumab combined with nab-paclitaxel demonstrated promising efficacy and safety for patients with non–muscle-invasive bladder cancer, according to findings from the phase 2 TRUCE-02 trial presented at the 2022 ASCO Annual Meeting.

“Patients with multiple or tumors with large invasion areas which are un-completely-resectable through TURBT [trans urethral resection of bladder tumor] would be recommended radical cystectomy in the clinical treatment,” wrote HaiTao Wang, MD, Tianjin Medical University, China, and colleagues.

“The KEYNOTE-057 study has illuminated the efficiency of immune checkpoint inhibitors monotherapy in [patients with high-risk non–muscle-invasive bladder cancer], with acceptable adverse events,” they continued.

The TRUCE-02 trial aimed to determine the role of a PD-1/PD-L1 inhibitor in combination with chemotherapy for this patient population.

A total of 54 patients were enrolled and received tislelizumab at 200 mg on days 1 plus nab-paclitaxel at 200mg on days 2, every 3 weeks, for 2 or 4 cycles. Treatment was followed with a comprehensive assessment that included pathology, urine cytology, and imageology, along with biomarker analyses.

There were 42 patients that completed 3 or 4 whole treatment cycles and reached the primary end point. Of those patients, 23 (56%) achieved a complete response. The overall response rate was 60%. The secondary end point of cystectomy-free condition was achieved by 33 patients (78.6%). Grade 3 to 4 adverse events (AEs) accounted for less than 2% of AEs reported, with the most common AEs being alopecia (81.8%, Grade 1 to 2) and fatigue (43.6%, Grade 1 to 2).

Urine cytology demonstrated diagnostic efficiency of 68.42% (95% confidence interval [CI], 61.3% to 75.6%), urine FISH of 45.71% (95% CI, 37.7% to 53.4%) before pathological assessment. Overall, 9 (47.3%) of 19 patients who experienced a response were PD-L1-positive and 5 (50%) of 10 patients who did not experience a response were PD-L1-positive.

“Tislelizumab with nab-paclitaxel represents a novel treatment option with a satisfactory benefit in treating [non–muscle-invasive bladder cancer]. PD-L1 expression has no obvious correlation with the efficiency of this treatment plan,” concluded Dr Wang and colleagues.

Source:

Wang H, Niu Y, Tian D, et al. TRUCE-02: An open label, single-arm, phase II study of tislelizumab combined with nab-paclitaxel for high-risk non-muscle-invasive urothelial bladder carcinoma. Presented at: ASCO Annual Meeting; June 3-7, 2022. Chicago, IL. Abstract 4507.