Combination anlotinib and sintilimab demonstrated “promising” antitumor activity in patients with recurrent, advanced endometrial cancer, according to researchers.
They presented results with this treatment in a poster at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
The researchers evaluated the safety and efficacy of sintilimab, an anti-PD-1 antibody, and anlotinib, a tyrosine kinase inhibitor with multiple targets, in a phase 2 trial (ClinicalTrials.gov Identifier: NCT04157491).
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The study enrolled 23 patients with recurrent, advanced endometrial cancer who had received at least one platinum-based systemic chemotherapy and had a performance status of 0 or 1.
At baseline, the patients’ median age was 56 years (range, 37-70 years). Disease stages included stage IA (21.7%), IB (8.7%), II (4.4%), IIIA (13.1%), IIIC (30.4%), and IVB (21.7%).
Sintilimab was given at 200 mg on day 1 of each 21-day cycle. Anlotinib was given at 12 mg once a day on days 1-14.
Endpoints included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
The ORR was 73.9%, and the DCR was 91.3%. There were 4 patients who achieved a complete response, 13 with a partial response, 4 with stable disease, and 2 with disease progression.
The median PFS was 12.8 months. OS data were not reported.
There were no treatment-related fatalities or unexpected safety signals. Most adverse events (AEs) were grade 1 or 2.
Grade 3-4 AEs included erythra (13%), hand-foot syndrome (8.7%), lymphocytopenia (8.7%), fatigue (4.3%), hypertension (4.3%), neutropenia (4.3%), immune myocarditis (4.3%), immune peritonitis (4.3%), and ileus (4.3%).
Disclosure: This research was supported by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Innovent Biologics, Inc. Please see the original reference for a full list of
disclosures.
Reference
Wei W, Ban X, Yang F, et al. Anlotinib plus sintilimab in patients with recurrent advanced endometrial cancer: a prospective open-label, single-arm, phase II clinical trial. J Clin Oncol. 2021;39:(suppl 15; abstr 5583). doi:10.1200/JCO.2021.39.15_suppl.5583
