Introduction Patients with heavily pretreated gynecological solid tumors have extremely limited treatment options. Lenvatinib combined therapy has efficacy in treating advanced endometrial carcinoma (including non-endometrioid), but nearly half of patients were intolerable toxicity of the recommended doses. Accordingly, we performed this pilot study to evaluate the efficacy and safety of low dose lenvatinib plus toripalimab in patients with heavily pretreated gynecological solid tumors.

Methods Lenvatinib was administered with a starting dose of 8 or 12 mg orally once daily based on patient’s body weight and an intravenous infusion of toripalimab was received at a dose of 240 mg every 3 weeks. Patients received therapy for up to 24 months until disease progression or unacceptable toxicity. The primary endpoint was progression free survival (PFS).

Results Twenty-one patients (ovarian, n=14; endometrial, n=6; vulvar, n=1), who experienced disease progression after prior median 3 lines of systemic therapy, were enrolled and treated from September 2021 to April 2023. In the 21 patients, the median PFS was 5.0 months , the median duration of response (DOR) was 5.2 months, and disease control rate(DCR) was 38.1%. The most common grade 3 treatment-related adverse events(TRAEs) were hypertension (33.3%) and proteinuria (9.5%), respectively. No grade 4 TRAEs occurred.

Conclusion/Implications This study, to our knowledge, is the first to explore the effects of low-dose lenvatinib plus Toripalimab in gynecological solid tumors. The encouraging efficacy and safety of this pilot study strongly support the further investigation of low-dose Lenvatinib plus Toripalimab in patients with heavily pretreated gynecological solid tumors.