Efficacy and safety of entrectinib in patients (pts) with NTRK-fusion positive (NTRK-fp) solid tumors: An updated integrated analysis.
Christian Diego Rolfo, Filippo G De Braud, Robert Charles Doebele, Alexander E Drilon, Salvatore Siena, Manish Patel, Byoung Chul Cho, Stephen V Liu, Myung-Ju Ahn, Chao-Hua Chiu, Anna F Farago, Koichi Goto, Jeeyun Lee, Lyudmila Bazhenova, Tom John, Marwan Fakih, Brian P Simmons, Bethany Pitcher, Xinhui Huang, George D Demetri
Journal of Clinical Oncology | American Society of Clinical Oncology (ASCO) | Published : 2020
3605 Background: NTRK gene fusions lead to transcription of chimeric TRK proteins with overexpressed kinase function. Entrectinib is a potent inhibitor of TRKA/B/C. In phase 1/2 studies (ALKA, STARTRK-1, STARTRK-2; EudraCT 2012-000148-88; NCT02097810; NCT02568267), entrectinib was effective in pts with NTRK-fp solid tumors. We present updated data in a larger population with longer follow-up. Methods: In this integrated analysis of adult pts from 3 phase 1/2 trials (data cut-off 31 Oct 2018), tumors were assessed by blinded independent central review (BICR) with RECIST v1.1 (end of cycle 1; then every 8 wks). Primary endpoints were overall response rate (ORR) and duration of response (DOR)...View full abstract