Long-term efficacy and updated survival outcomes of sintilimab plus anlotinib in patients with PD-L1-positive recurrent or metastatic cervical cancer.

Abstract

Background: Our phase 2 study has shown the efficacy and safety of sintilimab plus anlotinib as second- or later-line therapy in patients with programmed death-ligand 1 (PD-L1)-positive recurrent or metastatic cervical cancer who had failed prior chemotherapy. Here, we presented updated survival outcomes after a 3-year follow-up.

Methods: Patients received a regimen comprising 200 mg of sintilimab administered once on day 1 and 10 mg of anlotinib once daily on days 1-14 every 3 weeks. Treatment was continued until disease progression or intolerable toxicity. Updated overall survival (OS) and duration of response (DoR) were reported. For patients who received subsequent treatment after progression on sintilimab plus anlotinib, the second progression-free survival (PFS2) and objective response rate on subsequent treatment (ORR2) were analyzed.

Results: Between December 2019 and December 2020, a total of 42 patients were enrolled. As of July 12, 2024, the median follow-up duration was 47.2 months (range, 0.6-52.9). Median OS was 17.8 months (95% confidence interval [CI], 12.3-36.5) for 42 patients, and the median DoR was 13.2 months (95% CI, 8.2-41.8) for 23 patients with objective response. Median PFS2 was 23.6 months (95% CI, 12.5-29.8) and the ORR2 was 46.1% in 13 patients. Multivariate analysis identified PIK3CA mutation (hazard ratio = 3.43; 95% CI, 1.04-11.30; P = 0.043) as an independent prognostic factor for OS. The incidence of grade ≥ 3 treatment-related adverse events did not increase with extended follow-up.

Conclusions: Long-term follow-up showed persistent antitumor activity and maintained safety of sintilimab plus anlotinib in pre-treated patients with PD-L1-positive advanced cervical cancer.