Anlotinib enhances the efficacy of pembrolizumab in patients with recurrent or refractory high-grade serous ovarian cancer, according to research presented at the 2023 SGO Annual Meeting on Women’s Cancer.

Adding anlotinib to treatment with pembrolizumab improved responses and progression-free survival (PFS) in this phase 2 study.

The study ( Identifier: NCT05188781) enrolled 65 patients with recurrent or refractory high-grade serous ovarian cancer. The patients’ median age at baseline was 58.55 (range, 28-75) years. All patients had undergone surgery, none had a high tumor burden, and none had microsatellite instability-high disease.

Continue Reading

The patients were randomly assigned to receive anlotinib plus pembrolizumab (n=30) or pembrolizumab alone (n=35). All patients received pembrolizumab at 200 mg every 3 weeks. Patients in the combination arm also received anlotinib at 12 mg per day, 2 weeks on and 1 week off, every 3 weeks.

The median PFS was 7.0 months in the anlotinib-pembrolizumab arm and 4.3 months in the pembrolizumab monotherapy arm. The overall response rate was 60% and 34.3%, respectively.

In the anlotinib-pembrolizumab arm, patients harboring an ARID1A mutation had a significant PFS benefit over patients who had ARID1A wild-type disease (P =.04). 

The researchers also analyzed the tumor microenvironment and found that anlotinib increased the expression of CD4-positive T cells and enhanced susceptibility to pembrolizumab.

Grade 3 or higher treatment-related adverse events occurred in 5 patients in the combination arm and 3 patients in the monotherapy arm.

Disclosures: The study presenter reported having no conflicts of interest. 


Zhang X, Jiang M, Li T, et al. Anlotinib enhanced the efficacy of pembrolizumab in refractory or recurrent high-grade serous ovarian cancer by regulating the tumor microenvironment. SGO 2023. March 25-28, 2023.