An all-oral doublet composed of anlotinib and gefitinib exhibited efficacy in patients with treatment-naive, EGFR–mutated advanced non–small cell lung cancer (NSCLC), according to phase 2 study results presented at the 2021 European Society for Medical Oncology Congress.

Patients with NSCLC harboring EGFR mutations benefit from treatment with anti-angiogenic agents administered in combination with EGFR–directed tyrosine kinase inhibitors (TKI). Because the multi-target TKI anlotinib has been shown to improve progression-free survival (PFS) and overall survival (OS) in patients with advanced NSCLC, researchers sought to determine its potency when combined with gefitinib.

In a single-arm study, patients with previously untreated advanced NSCLC and confirmed EGFR mutations (exon 19 deletion, n = 13; L858R, n =8) were assigned anlotinib on a 21-day cycle (12 mg daily on days 1-14), along with daily gefitinib (250 mg). Treatment continued until disease progression or intolerability.

PFS served as the study’s primary outcome measure, with OS, overall response rate (ORR), disease control rate (DCR) and safety as secondary endpoints.

The study included data from 21 patients, with a median follow-up of 7.6 months. The ORR was 61.9%, with 13 patients achieving a partial response. The remaining eight patients achieved stable disease, for a DCR of 100%.

Objective responses were seen in 77% of patients with exon 19 deletions (n = 10) and 38% of patients with L858R mutations (n = 3).

Treatment remained ongoing for 16 patients, and the median PFS was not reached. The longest exposure at the time of reporting was 22.9 months. “The PFS and OS outcomes need further evaluation,” the researchers observed.

The researchers observed no grade 4 or grade 5 treatment-related adverse events. Commonly observed grade 3 events included hypertension (14.3%), rash (9.5%), and hand and foot skin reactions (9.5%).



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