Time To Response In Patients With Advanced Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small-Cell Lung Cancer (NSCLC) Receiving Alectinib In The Phase II NP28673 And NP28761 Studies

Autor: Shirish M. Gadgeel, Dong Wan Kim, Alice T. Shaw, Fabrice Barlesi, Lucio Crinò, Filippo de Marinis, Ravindra Gupta, James Chih-Hsin Yang, Anne-Marie C. Dingemans, Sai-Hong Ignatius Ou, Vlatka Smoljanovic, Shiyao Liu, Mathias Schulz
Rok vydání: 2019
Předmět:
Zdroj: Lung Cancer: Targets and Therapy. 10:125-130
ISSN: 1179-2728
DOI: 10.2147/lctt.s209231
Popis: Introduction Alectinib is a highly selective and potent ALK inhibitor, approved for the treatment of patients with metastatic ALK+ NSCLC based on results from the Phase II global NP28673 (NCT01801111) and North American NP28761 (NCT01871805) studies. Methods This exploratory analysis of two Phase II studies of alectinib (NP28673/NP28761) investigated time to systemic response (TTR) and time to central nervous system (CNS) response (TTCR) in patients with previously treated advanced anaplastic lymphoma kinase fusion gene-positive (ALK+) non-small-cell lung cancer. Patients (n=225) received 600 mg oral alectinib twice daily and had scans every 6/8 weeks (NP28673/NP28761). Results For NP28673 and NP28761, respectively: median follow-up was 21.3 months/17.0 months; most responders (72.6%/82.9%) responded by the first disease assessment; median TTR was 8 weeks (95% confidence interval [CI]: 8.00-8.14)/6 weeks (95% CI: 5.86-6.14); median TTCR in responders with measurable baseline CNS disease was 8 weeks (95% CI: 7.86-10.29)/6 weeks (95% CI: 5.71-not evaluable). Similar results were observed regardless of measurable/non-measurable disease. Discussion These data suggest that alectinib achieves a rapid response in patients, both systemically and in the CNS.
Databáze: OpenAIRE