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Association details:
| Biomarker: | EGFR exon 18 mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations
Excerpt:
...Tissue or blood samples are confirmed by the central laboratory or research center as rare EGFR mutations, including exon 18 G719X, E709X, etc., S768I in exon 20 and at least one of the L861Q mutations in exon 21; 4....
Trial ID:
Source:
Title:
Neratinib efficacy in patients with EGFR exon 18-mutant non-small-cell lung cancer: findings from the SUMMIT basket trial
Published date:
10/12/2022
Excerpt:
Eligible patients had EGFR exon 18-mutant NSCLC and ECOG performance status 0–2....Patients received neratinib (240 mg po daily)....ORR was 31% overall and 26% in patients pretreated with TKIs (Table 1). Two of 7 patients with baseline CNS metastasis had a partial response (PR; median PFS 3.6 months; 95% CI 1.9–9.1 months). Long-lived responses were observed in 3 patients with G719A/X/C mutations (2 PR, 1 SD)....Neratinib monotherapy had meaningful activity in patients with EGFR exon 18-mutant NSCLC in SUMMIT; 31% of patients had a PR and most patients had prior TKIs.
Trial ID:
Source:
Title:
Neratinib efficacy in a subgroup of patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC) and central nervous system (CNS) involvement: Findings from the SUMMIT basket trial.
Published date:
05/19/2021
Excerpt:
Best CNS response in these 3 patients was stable disease with overall individual PFS of 1.9 (censored), 6.9 and 9.1 months and OS of 2.6 (censored), 17.7 (censored), and 17.9 months….Activity of single-agent neratinib was observed in prior TKI-exposed patients with EGFR exon 18-mutant NSCLC.
DOI:
10.1200/JCO.2021.39.15_suppl.9068
Trial ID:
Source:
Title:
Puma Biotechnology Announces Interim Results from the Phase II SUMMIT Trial of Neratinib for EGFR Exon 18 Mutated, Metastatic Non-Small Cell Lung Cancer
Published date:
11/05/2020
Excerpt:
...patients with lung cancer with single or complex EGFR exon 18 mutations, who were EGFR TKI naïve or were previously exposed to EGFR TKI, were enrolled into this study and received 240 mg of neratinib daily as a single agent....8 patients (80%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 16 weeks). The median duration of response was 7.5 months and the median progression free survival was 9.1 months.
