Abstract 555P
Background
The treatment options after first-line chemotherapy for endometrial cancer (EC) are very limited. There is a substantial need for second line and subsequent treatment of advanced EC. Several immune checkpoint inhibitors or combined with antiangiogenic drugs have shown antitumor activity and been approved in EC. Anlotinib is a multiple-targeted tyrosine kinase inhibitor that has been approved for the treatment of several solid tumors. TQB2450 is a humanized monoclonal antibody targeting programmed death-ligand 1 (PD-L1). This multicohort, open label, multicenter, phase II study aims to evaluate the efficacy and safety of TQB2450 injection or combined with anlotinib hydrochloride capsule in the treatment of recurrent or metastatic advanced EC.
Methods
Patients with pathologically confirmed recurrent or metastatic advanced EC failed at 1 or 2 prior lines of therapy will be enrolled. Non-MSI-H/dMMR patients received TQB2450+anlotinib therapy (TQB2450 1200mg, IV D1/Q3W; anlotinib 12mg PO QD, D1-14/Q3W) until disease progression or intolerable toxicity experienced. This cohort plans to enroll 83 patients. The primary endpoint was the objective response rate (ORR) by independent review committee (IRC). Key secondary endpoints include ORR by investigator, disease control rate (DCR), duration of response (DoR), progression free survival (PFS), overall survival (OS) and safety.
Results
As of February 18, 2022, 29 patients had received at least one efficacy evaluation, and 1 patient was lost. The confirmed ORR was 33.3% (10/30). DCR was 76.7% (23/30), and median PFS was 6.6 months. The most frequently occurring (≥5%) grade 3 TEAEs were hypertension (20.63%) and hand-foot syndrome (HFS) (6.35%). Dose reduction due to TEAEs occurred in 22.22%, and the main was hypertension (6.35%).
Conclusions
TQB2450 plus anlotinib showed promising antitumor activity with a manageable safety profile in the treatment of recurrent or metastatic advanced EC.
Clinical trial identification
NCT04574284.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.