Neratinib Demonstrates Promising Efficacy for Patients With EGFR-Mutated Non-Small Cell Lung Cancer
According to results from the phase 2 SUMMIT basket trial, neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), demonstrated promising efficacy among patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
In this study, 31 patients with EGFR exon 18-mutant NSCLC received 240 mg of daily neratinib plus loperamide (as mandatory diarrhea prophylaxis). Patients were permitted to have undergone prior lines of EGFR TKIs (n = 24), chemotherapy, and checkpoint inhibitors. The primary end point was 8-week objective response rate (ORR). Key secondary end points included ORR, progression-free survival (PFS), duration of response, and safety.
At analysis, 8-week ORR was 19.4%. The ORR was 32.3% and the median PFS was 5.75 months. The median PFS for patients with baseline central nervous system metastasis was 3.6 months. A partial response of > 10 months was observed among 6 patients with g719A/X/C mutations. Grade 3 diarrhea was experienced by 10% of patients. No incidences of grade 4 diarrhea were reported. One patient discontinued study treatment due to diarrhea.
“Given the lack of effective treatments after EGFR TKI failure for NSCLC with uncommon mutations, further examination of neratinib is warranted,” concluded study authors.
Source:
Goldman JW, Bueno AM, Dooms C, et al. Neratinib efficacy in patients with EGFR exon 18-mutant non-small cell lung cancer: Findings from the SUMMIT basket trial. Clin Lung Cancer. Published online: December 10, 2024. doi: 10.1016/j.cllc.2024.12.003
