1119P Real-world efficacy and safety of anlotinib in combination with PD-1/PD-L1 inhibitors as first-line or second-line treatment in advanced non-small cell lung cancer

Abstract

Antiangiogenic therapy combined with PD-1/PD-L1 inhibitors has shown excellent efficacy in advanced NSCLC pts. The ALTER 0303 trial showed that anlotinib improved both PFS and OS in later-line treatment for advanced NSCLC. The purpose of this study is to investigate the efficacy and safety of anlotinib in combination with PD-1/PD-L1 inhibitors as first-line or second-line treatment in advanced non-small cell lung cancer in the real-world setting. This is a prospective, multicenter real-world study. The NSCLC cancer patients who received anlotinib in combination with PD-1/PD-L1 inhibitors in first-line or second-line were enrolled. The primary endpoint was PFS (progression-free survival), and secondary endpoints were ORR (objective response rate), DCR (disease control rate) and OS (overall survival). The response to treatment was evaluated according to RECIST version 1.1. In addition, adverse events were evaluated by CTCAE v5.0. From Aug 2021 to Apr 2022, 69 patients were enrolled in fifteen centers and 23 of them have received at least one tumor assessment. Median age was 66 (range:39-79); 78.3% male, 4.3% brain metastasis, 91.3% ECOG PS 1. 10 (43.5%) and 13 (56.5%) patients received anlotinib combined with PD-1 inhibitors as first-line and second-line therapy, respectively. Among all patients, 6 patients were partial response (PR), 15 patients were stable disease (SD), illustrating ORR of 26.1% and DCR of 91.3%. In the first-line, ORR was 20%, DCR was 90%. In the second-line, ORR was 30.8%, DCR was % 92.3. Median PFS was 7.70 months (95%Cl: 4.49, 10.91) and median OS was not reached. The most common Grade 3-4 AEs were neutropenia 4.34%, thrombocytopenia 4.34%, leukopenia 4.34%, hand-foot syndrome 4.34% and there were no Grade 4/5 toxicities. This real-word study finds that anlotinib combined with PD-1/PD-L1 inhibitors shows good efficacy and safety in NSCLC patients. The treatment effects are similar to the outcomes in comparable clinical trials, which support the further recommendation of anlotinib combined with PD-1 inhibitors in the treatment of NSCLC.