Fruquintinib plus sintilimab in advanced cervical cancer: an open-label, multicentre, phase 2 study

BACKGROUND: Efficacy of second-line treatments after first-line platinum-based chemotherapy in advanced cervical cancer is modest. This open-label, single-arm, multicentre, proof-of-concept phase 2 study evaluated fruquintinib plus sintilimab in advanced cervical cancer. METHODS: Patients recruited between July 2021 and June 2022 had received at least first-line platinum-based chemotherapy or were unable to receive standard treatment in China. Patients received fruquintinib 5 mg once daily orally (2 weeks on/1 week off) plus sintilimab 200 mg intravenously every 3 weeks. Efficacy and safety analyses included patients who had received at least one dose of study drug. RESULTS: Here we show the results of 34 patients who received treatment; 28 (82%) have prior systemic antitumour therapy, with 19 (68%) pretreated patients having programmed death ligand 1 (PD-L1) combined positive score (CPS) ≥ 1. The objective response rate (ORR) is 32% (95% confidence interval [CI] 17-51), meeting the prespecified effective boundary, and the disease control rate (DCR) is 97% (95% CI 85-100). Median progression-free survival (PFS) and overall survival (OS) are 8.3 months (95% CI 5.5-19.4) and 23.5 months (95% CI 15.8-not estimable [NE]), respectively. The most common grade ≥ 3 treatment-related adverse event is palmar-plantar erythrodysaesthesia syndrome (21%). In pretreated patients with PD-L1 CPS ≥ 1, ORR is 37% (95% CI 16-62), median PFS is 19.4 months (95% CI 4.0-22.1), and OS rate at 18 months is 72% (95% CI 46-87). CONCLUSIONS: Fruquintinib plus sintilimab may indicate favourable and durable antitumour activity with a manageable safety profile in advanced cervical cancer, especially in pretreated patients with PD-L1 CPS ≥1, warranting further investigation.