Abstract
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.
Plain language summary
Cervical cancer is one of the deadliest forms of cancer for women, and survival is poor. This study aimed to explore whether combining fruquintinib, a therapy that blocks the growth of new blood vessels, with sintilimab, an immunotherapy, could improve outcomes for patients with advanced cervical cancer. We treated 34 patients, 28 of whom previously received treatment. The combination was able to control the disease in all but one patient. We found that the disease progressed after an average of 8.3 months, and patients survived for an average of 25.3 months. The side effects of this combination were generally manageable. These findings suggest that this combination therapy may be a useful approach in patients with advanced cervical cancer.
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Data availability
De-identified participant data that underlie Figs. 2 and 3 are accessible from Supplementary Data 1. Any additional information (including trial protocol or statistical analysis plan) is available to investigators for research purposes on a case-by-case basis after the time of this publication. Requests for access to data should be addressed to SF (songhuaf@hutch-med.com) for consideration. The response to data access requests will be made within 4 weeks of receipt.
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Acknowledgements
This study was funded by HUTCHMED and Innovent Biologics, Inc. HUTCHMED was involved the study design, providing fruquintinib, data collection, data analysis, data interpretation, writing of the report, and the decision to submit for publication. Innovent Biologics, Inc. provided sintilimab. Medical writing and editorial support were provided by Mandakini Singh, PhD, and Lawrence Law, MPH, of Parexel and funded by HUTCHMED.
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X.W., P.T., S.F. and W.S. conceptualised and designed the study. All authors acquired, analysed, and interpreted the data. K.C. performed the statistical analysis. X.W., K.C., P.L., H.S., P.T. and S.F. drafted the manuscript. All authors critically reviewed the manuscript for important intellectual content. X.W., D.W., Ji.W., Y.H., T.Y., G.L., J.Z., K.W., Y.K., A.L., X.H., X.R., L.L., R.Y., Q.L., Q.Y., B.Z., Ju.W., H.Y. and Y.T. provided administrative, technical, and material support. X.W. had full access to all of the data in the study and took responsibility for the integrity of the data and the accuracy of the data analysis.
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K.C., P.L., H.S., P.T., S.F., M.M.S., and W.S. are employees of HUTCHMED. All other authors have declared no conflicts of interest.
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Communications Medicine thanks Gennaro Daniele, Tao Chen and the other, anonymous, reviewer(s) for their contribution to the peer review of this work. A peer review file is available.
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Wu, X., Wang, D., Wang, J. et al. Fruquintinib plus sintilimab in advanced cervical cancer: an open-label, multicentre, phase 2 study. Commun Med (2026). https://doi.org/10.1038/s43856-026-01572-z
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DOI: https://doi.org/10.1038/s43856-026-01572-z
