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

Autor: F Smit, Egbert, Dooms, Christophe, Raskin, Jo, Nadal, Ernest, Tho, Lye M, Le, Xiuning, Mazieres, Julien, S Hin, How, Morise, Masahire, W Zhu, Viola, Tan, Daniel, H Holmberg, Kristina, Ellers-Lenz, Barbara, Adrian, Svenja, Brutlach, Sabine, Schumacher, Karl M, Karachaliou, Niki, Wu, Yi-Long
Zdroj: Future Oncology; Apr2022, Vol. 18 Issue 9, p1039-1054, 16p
Abstrakt: 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). [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index