INSIGHT 2: a phase II study of tepotinib plus osimertinib in MET-amplified NSCLC and first-line osimertinib resistance

Autor: Egbert F Smit, Christophe Dooms, Jo Raskin, Ernest Nadal, Lye M Tho, Xiuning Le, Julien Mazieres, How S Hin, Masahire Morise, Viola W Zhu, Daniel Tan, Kristina H Holmberg, Barbara Ellers-Lenz, Svenja Adrian, Sabine Brutlach, Karl M Schumacher, Niki Karachaliou, Yi-Long Wu
Rok vydání: 2022
Předmět:
Zdroj: Future Oncology. 18:1039-1054
ISSN: 1744-8301
1479-6694
Popis: MET amplification (METamp), a mechanism of acquired resistance to EGFR tyrosine kinase inhibitors, occurs in up to 30% of patients with non-small-cell lung cancer (NSCLC) progressing on first-line osimertinib. Combining osimertinib with a MET inhibitor, such as tepotinib, an oral, highly selective, potent MET tyrosine kinase inhibitor, may overcome METamp-driven resistance. INSIGHT 2 (NCT03940703), an international, open-label, multicenter phase II trial, assesses tepotinib plus osimertinib in patients with advanced/metastatic EGFR-mutant NSCLC and acquired resistance to first-line osimertinib and METamp, determined centrally by fluorescence in situ hybridization (gene copy number ≥5 and/or MET/CEP7 ≥2) at time of progression. Patients will receive tepotinib 500 mg (450 mg active moiety) plus osimertinib 80 mg once-a-day. The primary end point is objective response, and secondary end points include duration of response, progression-free survival, overall survival and safety. Trial registration number: NCT03940703 (clinicaltrials.gov). ispartof: FUTURE ONCOLOGY vol:18 issue:9 pages:1039-1054 ispartof: location:England status: published
Databáze: OpenAIRE