300P - 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

Background

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.

Methods

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.

Results

From Aug 2021 to Jul 2022, 124 patients were enrolled in fifteen centers and 39 of them have received at least one tumor assessment. Median age was 66 (range:40-84); 84.6% male, 5.1% brain metastasis, 87.2% ECOG PS 1. 22 (59.5%) and 17 (43.6%) patients received anlotinib combined with PD-1 inhibitors as first-line and second-line therapy, respectively. Among all patients, 8 patients were partial response (PR), 27 patients were stable disease (SD), illustrating ORR of 20.5% and DCR of 89.7%. In the first-line, ORR was 13.6%, DCR was 90.9%. In the second-line, ORR was 29.4%, DCR was 88.2%. Median PFS was 7.70 months (95%Cl: 5.13, 10.27) and median OS was not reached. The most common Grade 3-4 AEs were neutropenia 2.6%, thrombocytopenia 2.6%, leukopenia 2.6%, hand-foot syndrome 2.6%, Elevated alkaline phosphatase 2.6% and there were no Grade 4/5 toxicities.

Conclusions

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.

Clinical trial identification

ChiCTR 2100049975.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.