Abstract 799P
Background
Endometrial cancer is one of the most common gynecologic malignancies in the world. however, the effects of systemic chemotherapy are limited. The combination of targeted therapy with immunotherapy is a new research field in the treatment of malignant tumors. This research aimed to evaluate the efficacy and safety of the combination of anlotinib and sintilimab in patients with recurrent advanced endometrial cancer.
Methods
Patients who received at least one platinum-based systemic chemotherapy, had an ECOG performance status of 0 or 1 were considered eligible for enrollment. Sintilimab was administered intravenously (200mg，q3w); anlotinib was taken orally (12mg qd, d1-14, 21 days per cycle). The treatment was continued until disease progression, death or intolerant toxicity. The primary endpoint was objective response rate and the secondary endpoints included duration of response, disease control rate, progression-free survival, overall survival and safety.
Results
From November 2019 to March 2021, 23 patients with a median age of 56 years (range: 37-70). Among these participants, 22 patients were evaluable. The therapeutic evaluation showed the incidence of complete response, partial response, stable disease and progression disease was 13.6%, 63.7%, 13.6% and 9.1%, respectively, yielding the ORR of 77.3% (95%CI: 54.6%-92.2%) and the DCR of 86.4% (95%CI: 65.1%-97.1%). ≥1 and ＜1 Combined Positive Score of PD-L1 expression were observed in 66.7% and 33.3% patients, respectively, and the ORR was 92.9% (95%CI: 77.4%-100%) and 57.1% (95%CI: 18.4%-90.1%) in the two groups. The median PFS was 4.8 months (range, 0.7-12.8). Most of the occurring adverse events were grade 1 or 2. Grade 3 AEs included ileus (4.3%), immune myocarditis (4.3%) immune peritonitis (4.3%), hand-foot syndrome (8.7%), neutropenia (4.3%), neutrophils decrease (4.3%), and hypertension (4.3%); Grade 4 AE was lymphocytosis (4.3%). Neither unexpected safety signals nor treatment-related death occurred.
Conclusions
Anlotinib plus sintilimab showed a promising antitumor activity with a favorable toxicity profile for patients with recurrent advanced endometrial cancer. We will report more data in the future.
Clinical trial identification
NCT04157491.
Editorial acknowledgement
Legal entity responsible for the study
J. Li.
Funding
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.