Abstract
<div>AbstractPurpose:<p>The final analyses of the INSIGHT phase II study evaluating tepotinib (a selective MET inhibitor) plus gefitinib versus chemotherapy in patients with <i>MET</i>-altered <i>EGFR</i>-mutant NSCLC (data cut-off: September 3, 2021).</p>Patients and methods:<p>Adults with advanced/metastatic <i>EGFR</i>-mutant NSCLC, acquired resistance to first-/second-generation EGFR inhibitors, and <i>MET</i> gene copy number (GCN) ≥5, <i>MET</i>:<i>CEP7</i> ≥2, or MET IHC 2+/3+ were randomized to tepotinib 500 mg (450 mg active moiety) plus gefitinib 250 mg once daily, or chemotherapy. Primary endpoint was investigator-assessed progression-free survival (PFS). <i>MET</i>-amplified subgroup analysis was preplanned.</p>Results:<p>Overall (<i>N</i> = 55), median PFS was 4.9 months versus 4.4 months [stratified HR, 0.67; 90% CI, 0.35–1.28] with tepotinib plus gefitinib versus chemotherapy. In 19 patients with <i>MET</i> amplification (median age 60.4 years; 68.4% never-smokers; median GCN 8.8; median <i>MET/CEP7</i> 2.8; 89.5% with MET IHC 3+), tepotinib plus gefitinib improved PFS (HR, 0.13; 90% CI, 0.04–0.43) and overall survival (OS; HR, 0.10; 90% CI, 0.02–0.36) versus chemotherapy. Objective response rate was 66.7% with tepotinib plus gefitinib versus 42.9% with chemotherapy; median duration of response was 19.9 months versus 2.8 months. Median duration of tepotinib plus gefitinib was 11.3 months (range, 1.1–56.5), with treatment >1 year in six (50.0%) and >4 years in three patients (25.0%). Seven patients (58.3%) had treatment-related grade ≥3 adverse events with tepotinib plus gefitinib and five (71.4%) had chemotherapy.</p>Conclusions:<p>Final analysis of INSIGHT suggests improved PFS and OS with tepotinib plus gefitinib versus chemotherapy in a subgroup of patients with <i>MET</i>-amplified <i>EGFR</i>-mutant NSCLC, after progression on EGFR inhibitors.</p></div>
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