A phase 2 study of tislelizumab combined with bevacizumab and chemotherapy as first-line treatment for persistent, recurrent, or metastatic cervical cancer

Background: To investigate the efficacy and safety of first-line treatment with tislelizumab plus low-dose bevacizumab and standard chemotherapy in patients with persistent, recurrent, or metastatic cervical cancer. Methods: ) or carboplatin (AUC = 5) on day 1 of cycle 1 (every 3 weeks) in safety run-in stage. Patients entered dose expansion stage to receive the treatment if no dose-limiting toxicities were reported in ≥2 of the 6 patients. Primary end point was progression-free survival (PFS). Safety, tolerability, objective response rate (ORR), and disease control rate (DCR) as well as duration of response (DOR) for persistent, recurrent, or metastatic cervical cancer were the secondary end points. Findings: Between May 2022 and March 2023, a total of 51 patients were enrolled from 8 centers across China (median age: 54 years), and most had distant metastases at enrollment (54.9%). Median PFS reached 22.6 months (95% CI: 14.6, not reached). The ORR was 91.5% (95% CI: 79.6, 97.6), DCR was 100% (95% CI: 92.5, 100.0) and the 18-month DOR rate was 51.5% (95% CI: 31.0, 68.7). Anemia and decreased platelet count were the most common grade ≥3 treatment-emergent (21.6% and 19.6%, respectively) and treatment-related adverse events (TRAEs, 17.6% each). Grade ≥3 TRAEs of special interest associated with bevacizumab were proteinuria (3.9%), fistula and vaginal bleeding (2.0% each). Interpretation: Tislelizumab in combination with low-dose bevacizumab and chemotherapy demonstrated promising efficacy with favorable safety profile as first-line treatment for persistent, recurrent, or metastatic cervical cancer. Funding: This work was supported by grants from the Pioneer R&D Program of Zhejiang (2023SDYXS0001, 2022C03031) and by BeiGene (Beijing) Co., Ltd. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.