The following is a summary of “Phase 2 Study of Preoperative Tislelizumab in Combination with Low-dose Nab-Paclitaxel in Patients with Muscle-invasive Bladder Cancer,” published in the May 2024 issue of Urology by Wu et al.

Recent advancements in treating advanced urothelial carcinoma have highlighted the potential benefits of combining immune checkpoint inhibitors with nab-paclitaxel. This study aimed to evaluate the efficacy and safety of tislelizumab in combination with low-dose nab-paclitaxel for patients diagnosed with muscle-invasive bladder cancer (MIBC).

The TRUCE-01 trial was a phase 2, single-arm study involving 62 patients with T2-4a N0/X M0 MIBC tumors, predominantly of urothelial carcinoma histology. Participants received three 21-day cycles of intravenous tislelizumab (200 mg on day 1) and nab-paclitaxel (200 mg on day 2), followed by surgical assessment. The primary endpoint was achieving a clinical complete response (cCR). Treatment-related adverse events (TRAEs) were assessed using Common Terminology Criteria for Adverse Events version 5.0.

Of the 62 patients evaluated for safety and 48 for efficacy, 25 patients (52%) achieved the primary endpoint of cCR. The safety analysis revealed that 9.7% of patients experienced grade ≥3 TRAEs, indicating a manageable safety profile with this regimen.

The combination of tislelizumab and low-dose nab-paclitaxel demonstrated robust antitumor efficacy and was generally well tolerated in patients with MIBC. These findings suggest that this regimen holds promise as an effective preoperative therapy option for individuals with muscle-invasive bladder cancer.

Source: sciencedirect.com/science/article/pii/S258893112400110X