Efficacy and safety with aumolertinib plus anlotinib for untreated EGFR-mutant NSCLC with brain metastases

The efficacy and prognosis of epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC) patients with brain metastases (BMs) are poor. The third-generation EGFR-tyrosine kinase inhibitor proved to have better intracranial efficacy, which combined with anti-angiogenic drugs can further improve the efficacy. We conducted a single-arm, phase 2 clinical study (GASTO-1063) to explore the intracranial efficacy of aumolertinib plus anlotinib for NSCLC with BMs, with 87 patients enrolled. Median intracranial progression-free survival (PFS) was 30.2 months, median overall PFS was 22.5 months, and median overall survival was not reached. The intracranial objective response rate and intracranial disease control rate were 71.3% and 93.1%. Patients with exon 19 deletion or wild-type TP53 exhibited significantly longer intracranial PFS and PFS compared to those with exon 21 L858R mutation or mutated TP53. Aumolertinib plus anlotinib was effective and well-tolerated as first-line therapy in EGFR-mutant NSCLC patients with BMs. Trial Registration: ClinicalTrials.gov(identifier NCT04978753, registered July 20, 2021).