Tislelizumab plus nab-paclitaxel shows therapeutic potential against bladder cancer

Treatment with the combination of the immune checkpoint inhibitor tislelizumab plus low-dose nab-paclitaxel exerts promising antitumour activity in patients with very high risk non–muscle-invasive bladder cancer who are ineligible for or decline radical cystectomy, according to the results of the phase II TRUCE-02 trial.

TRUCE-02 included 63 patients (median age 67 years, 83 percent male) with visually incomplete resection and/or high-volume high-grade T1 tumours (with or without carcinoma in situ) who declined radical cystectomy or were ineligible for the procedure.

All patients received tislelizumab at 200 mg on day 1 and nab-paclitaxel at 200 mg on day 2, administered intravenously every 3 weeks. Assessment was conducted approximately 3 months after initial administration.

Complete response of high-risk disease was the primary endpoint. Safety and duration of complete response were also evaluated as secondary endpoints.

The efficacy analysis included 59 patients, while the safety analysis included all 63 patients. The median treatment duration was 4.8 months for a median of six treatment administrations.

Complete response of high-risk disease was achieved in 37 patients (62.7 percent, 95 percent confidence interval [CI], 49.1–75.0). The 24-month sustained response rate was 96.3 percent (95 percent CI, 89.4–100.0).

In terms of safety, grade 3 to 4 treatment-related adverse events were documented in nine patients (14 percent), none of which were fatal.