Osimertinib plus Gefitinib in Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer and EGFR (C797X) Mutation Following First-Line Osimertinib: ORCHARD.

ABSTRACT:

Purpose

ORCHARD (NCT03944772) was a phase II, open-label study evaluating resistance mechanisms and postprogression therapies in patients with epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC) with progressive disease (PD) on first-line osimertinib. We report final data from the osimertinib plus gefitinib module in patients with EGFR C797X, a known resistance mechanism to osimertinib.

Patients and methods

Patients received once-daily osimertinib 80 mg plus gefitinib 250 mg until PD, unacceptable toxicity, or another discontinuation criterion. The primary endpoint was objective response rate (ORR) by investigator per Response Evaluation Criteria in Solid Tumors 1.1.

Results

Thirty-one patients were treated and evaluable for res

SUBMITTER: Goldberg SB 

PROVIDER: S-EPMC13628098 | biostudies-literature | 2026 Oct

REPOSITORIES: biostudies-literature