Efficacy of Neratinib-Based Therapy in ERBB2-Mutant Lung Adenocarcinomas: Findings From 2 International Phase 2 Studies.

ABSTRACT:

Background

ERBB2 mutations are oncogenic drivers in 2% to 4% of lung cancers and potentially actionable using HER2 tyrosine kinase inhibitors.

Patients and methods

Patients with advanced ERBB2-mutant lung cancer entered 2 phase 2 studies (PUMA-NER-4201 [4201]; PUMA-NER-5201 [SUMMIT]). Patients received neratinib (monotherapy 4201; monotherapy SUMMIT), or neratinib with weekly temsirolimus (combination 4201), or trastuzumab every 3 weeks (combination SUMMIT). Protocol-defined endpoints common to both studies were analyzed. Exploratory genomic analyses were conducted.

Clinicaltrials

gov: NCT01827267; NCT01953926.

Results

Sixty patients in 4201 (neratinib, n = 17; neratinib plus temsirolimus, n = 43) and 78 in SUMMIT (neratinib, n = 26; neratinib plus trastuzumab,

SUBMITTER: Li BT 

PROVIDER: S-EPMC12696912 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature