1487P - 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: Updated results

Background

Immune checkpoint inhibitors (ICIs) regimens are the cornerstone of first-line treatment of advanced non-small cell lung cancer (NSCLC).Anlotinib is a multi-targeted tyrosine kinase inhibitor selective for VEGFR, FGFR, PDGFR, and c-kit. The ALTER 0303 trial showed that anlotinib improved both PFS and OS in later-line treatment for advanced NSCLC. Anti-angiogenesis agents has synergistic effect with ICIs. Anlotinib combined with PD-1/PD-L1 inhibitors as first-line or second-line treatment in advanced NSCLC showed encouraging efficacy and good tolerability. This is an update of the real-world study.

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, and secondary endpoints were ORR, DCR and OS. 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 May 2023, 147 patients were enrolled in fifteen centers and 104 of them have received at least one tumor assessment. Median age was 66.3 (range:40-84); 82.7% male, 6.7% brain metastasis, 67.3% ECOG PS 1. 60 (57.7%) and 44 (42.3%) patients received anlotinib combined with PD-1 inhibitors as first-line and second-line therapy, respectively. Among all patients, 29 patients were partial response (PR), 72 patients were stable disease (SD), illustrating ORR of 27.9% and DCR of 97.1%. In the first-line, ORR was 30.0%, DCR was 96.6%. In the second-line, ORR was 25.0%, DCR was 97.7%.The median follow-up time was 9.4 months (95%Cl:8.1-10.7). Median PFS and median OS were not reached. The most common Grade 3-4 AEs were decreased lymphocyte count (3.8%), decreased platelet count (2.8%), decreased white blood cells (1.9%), neutropenia (1.9%), hand-foot syndrome (1.0%) and there were no Grade 5 toxicities.

Conclusions

The combination of anlotinib and PD-1/PD-L1 inhibitors may represent a new treatment option as first-line or second-line treatment in advanced NSCLC. The further exploration is ongoing.

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.