TOKYO, March 15, 2019 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it filed a new drug application to the Ministry of Health, Labour and Welfare (MHLW) for a ROS1/TRK inhibitor entrectinib for the treatment of ROS1 fusion-positive non-small cell lung cancer (NSCLC).

“With the previous filing of NTRK fusion-positive solid tumors, which is a rare type of cancer, and ROS1 fusion-positive NSCLC, which accounts for one to two percent of NSCLC, Chugai wishes that entrectinib would become a new treatment option for these patients and we will continue working to contribute to the development of personalized medicine," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit.

This application for approval is based on an integrated analysis of an open-label, multicenter, global phase II study (the STARTRK-2 study) and three overseas phase I studies (the STARTRK-NG study, the STARTRK-1 study and the ALKA-372-001 study). Efficacy was evaluated in 53 patients with ROS1 fusion-positive NSCLC while safety assessment was conducted with 355 patients registered in the four trials.

As the top pharmaceutical company in the field of oncology in Japan, Chugai will work to obtain early approval in order to provide entrectinib as a new treatment option for patients and medical professionals.

[Reference information]

• Media release issued by Roche on February 19, 2019
  Title: FDA grants Priority Review to Roche’s personalised medicine entrectinib
  https://www.roche.com/media/releases/med-cor-2019-02-19b.htm
• Media release issued by Chugai on December 19, 2018
  Title: Chugai Files a New Drug Application for a ROS1/TRK Inhibitor Entrectinib for the Treatment of NTRK Fusion-Positive Solid Tumors
  https://www.chugai-pharm.co.jp/english/news/detail/20181219170000_579.html
• Media release issued by Roche on September 24, 2018
  Title: Roche’s investigational medicine entrectinib showed a durable response of more than two years in people with a specific type of lung cancer
  https://www.roche.com/media/releases/med-cor-2018-09-24c.htm

About entrectinib
Entrectinib is an oral medicine in filling for approval for the treatment of locally advanced or metastatic solid tumors that harbor NTRK1/2/3 or ROS1 gene fusions. It is a selective, CNS-active tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. Entrectinib can block ROS1 and NTRK kinase activity and inhibit proliferation of cancer cells with ROS1 or NTRK gene fusions. FDA has granted priority review for entrectinib for the treatment of NTRK fusion-positive solid tumors and ROS1 fusion-positive NSCLC.

About ROS1 fusion-positive NSCLC
ROS1 fusion gene is an abnormal gene that can be formed by fusing the ROS1 gene and other genes (CD74, etc.) as a result of chromosomal translocation for some reason. The ROS1 fusion kinase made from ROS1 fusion gene is thought to promote cancer cell proliferation. ROS1 fusion gene is found in about one to two percent of non-small cell lung cancer, among which it is more expressed in adenocarcinoma.