Efficacy of Entrectinib in Patients (PTS) with Solid Tumors and Central Nervous System (CNS) Metastases: Integrated Analysis from 3 Clinical Trials
Invited conference paper presented and published in conference proceedings

香港中文大學研究人員

引用次數
替代計量分析
.

其它資訊
摘要Background:
Entrectinib potently inhibits kinases encoded by the NTRK and ROS1 genes. It achieves therapeutic levels in the CNS with antitumor activity in intracranial tumor models. We report integrated data (31 May 2018 cut-off) from 3 Phase 1/2 entrectinib trials (ALKA-372-001, EudraCT 2012-000148-88; STARTRK-1, NCT02097810; STARTRK-2, NCT02568267) for a large cohort of adults with ROS1 fusion-positive NSCLC (ROS1+) or NTRK fusion-positive solid tumors (NTRK+), with/without baseline CNS metastases.
Methods:
Pts had locally advanced/metastatic NTRK+ or ROS1+ tumors by nucleic acid-based confirmation. Baseline CNS metastases were identified by CT/MRI. Tumor assessments were at wk 4, then every 8 wk by blinded independent central review (RECIST v1.1). Primary endpoints: ORR, DOR. Secondary endpoints: CBR, PFS, OS, intracranial efficacy and safety.
Results:
Most pts had ≥1 prior therapy; 33% had baseline CNS metastases. Outcomes for the ROS1+ NSCLC (n = 53) and NTRK+ solid tumors (n = 54; 24% sarcoma, 18% NSCLC) efficacy evaluable data sets are shown (table). Entrectinib was tolerable with a manageable safety profile; most treatment-related AEs were grade 1–2.
Conclusions:
Entrectinib induced clinically meaningful durable responses in pts with ROS1+ NSCLC or NTRK+ solid tumors with or without CNS disease. Clinical trial information: NCT02097810; NCT02568267
著者Salvatore Siena, Robert Charles Doebele, Alice Tsang Shaw, Christos Stelios Karapetis, Daniel Shao-Weng Tan, Byoung Chul Cho, Dong-Wan Kim, Myung-Ju Ahn, Matthew Krebs, Koichi Goto, Pilar Garrido Lopez, Anna F. Farago, Herbert H. F. Loong, Diego Tosi, Minal A. Barve, Brian P. Simmons, Chenglin Ye, Susan Eng, Alexander E. Drilon
會議名稱2019 American Society of Clinical Oncology (ASCO) Annual Meeting
會議開始日31.05.2019
會議完結日04.06.2019
會議地點Chicago
會議國家/地區美國
會議論文集題名Journal of Clinical Oncology
系列標題Developmental Therapeutics and Tumor Biology (Nonimmuno)
叢書冊次Abst 3017
出版年份2019
月份5
卷號37
期次Suppl 15
出版社American Society of Clinical Oncology
國際標準期刊號0732-183X
電子國際標準期刊號1527-7755
語言英式英語
關鍵詞central nervous system

上次更新時間 2020-09-07 於 01:04