865P A phase II study of sintilimab plus anlotinib for Chinese patients (pts) with persistent, recurrent, or metastatic cervical cancer (CC)

Abstract

There are limited effective treatments for CC pts who have previously received multiple lines of chemotherapy. The combination of immune checkpoint inhibitors (ICIs) plus angiogenesis inhibitors has demonstrated significant activity in certain cancers. The objective of this study was to determine the efficacy and safety of sintilimab (a fully human programmed death-1 ICI) plus anlotinib (a multi-target tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signaling) in persistent, recurrent, or metastatic CC pts. Patients who received at least one platinum-based systemic chemotherapy, with histopathologically confirmed recurrent or metastatic advanced cervical cancer (including squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma), with more than 1% PD-L1 expression, and ECOG 0-1 were considered eligible for enrolment. Sintilimab was administered intravenously (200mg once every 3weeks); anlotinib was taken orally (10mg mg qd, d1-14; 21 days per cycle). The treatment was continued until disease progression, death or intolerable toxicity. The primary endpoint was objective response rate (ORR) and the secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. From September 2019 to April 2020, 16 patients were recruited with a median age of 52 years (range:36-67), FIGO histopathological stage I (6.3%), II (43.7%), III (25%), IV (6.3%) or undiagnosed (18.7%) were enrolled. Among these patients, 11 were evaluable. The therapeutic evaluation showed the incidence of complete response, partial response, stable disease and progressive disease was 9.1%, 45.5%, 45.5% and 0%, respectively, yielding an ORR of 54.5% and DCR of 100%. The median PFS was not reached. Frequently occurring adverse effects (AEs) were grade 1 or 2, intolerance was only observed in 1 patient. Anlotinib plus sintilimab showed promising efficacy with a favourable toxicity profile for patients with persistent, recurrent, or metastatic cervical cancer. We will report more data in the future.