Multicenter phase 2 study of andamertinib for pretreated advanced non-small cell lung cancer with EGFR exon 20 insertions

The multicenter phase 2 KANNON study in China evaluated the tyrosine kinase inhibitor andamertinib for advanced non-small cell lung cancer (aNSCLC) with EGFR exon 20 insertions (ex20ins) after platinum-based chemotherapy or immunotherapy. A total of 92 patients with nearly 30 different ex20ins subtypes were enrolled and received andamertinib 240 mg once daily. The primary endpoint was confirmed objective response rate assessed by independent review. cORR was 42.7% (95% CI 32.4-53.0) with a disease control rate of 86.5% and a median duration of response of 8.7 months. The median progression-free survival was 6.2 months (95% CI 4.63-7.85) and the median overall survival was not reached with mediane duration of follow-up of 15.4 months; the 12-month OS rate was 70.5%. Among 38 patients with brain metastasis, the systemic cORR was 47.4% (95% CI 31.5-63.2). Grade ≥ 3 treatment-related adverse events occurred in 40.2% of patients; the most frequent events were diarrhea (12%) and rash (7.7%). No interstitial lung disease of grade ≥ 3 QT prolongation was reported. The authors conclude that andamertinib 240 mg once daily demonstrated efficacy and manageable safety in previously treated patients with EGFR ex20ins aNSCLC.