Which treatments for non-small cell lung cancer (NSCLC) are targeting ROS-1 mutations?

Updated: Aug 21, 2019
  • Author: Maurie Markman, MD, MS; Chief Editor: Keith K Vaux, MD  more...
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In March 2016, the FDA expanded use of crizotinib to include patients with metastatic NSCLC whose tumors harbor a ROS-1 gene mutation. Study results showed crizotinib exhibited marked antitumor activity in this population, with an objective response rate of 66% by an independent radiology review. There was 1 complete response and 32 partial responses. The median duration of response was 18.3 months. [39]

Entrectinib (Rozyltrek) was approved in August 2019 for metastatic NSCLC in adults whose tumors are ROS1-positive. Entrectinib and its major metabolite inhibit tropomyosin receptor tyrosine kinases (TRKs), proto-oncogene tyrosine-protein kinase ROS1 (ROS1), and anaplastic lymphoma kinase (ALK).

Approval of entrectinib for NSCLC was based on pooled analysis of 3 multicenter, single-arm, open-label trials (ALKA, STARTRK-1, STARTRK-2). Of the 51 patients with ROS1-positive confirmed NSCLC who were assessed, ORR was 78%, and 55% had a duration of response (DOR) of at least 12 months. Favorable results were also shown in patients with CNS metastases. [40, 41]

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