On January 4, CStone Pharmaceutical (02616. HK) announced that a clinical trial application (IND) for ROS1-positive advanced non-small cell lung cancer (NSCLC) has been approved by the State Drug Administration of China (NMPA). This is the world's first pivotal study of loratinib in the treatment of ROS1-positive NSCLC.
It is understood that the study aims to evaluate the antitumor activity and safety of loratinib in ROS1-positive advanced NSCLC patients, and will enroll ROS1-positive advanced NSCLC patients who have failed chemotherapy and precision treatment, and the primary endpoint of the study is the objective response rate (ORR) assessed by an independent review committee.
Statistics show that more than 670,000 NSCLC cases are confirmed in China every year, of which about 2%-3% of patients are caused by ROS1 gene rearrangement, the scale of about 20,000 people, mostly in young, non-smoking or mildly smoking lung adenocarcinoma patients. As a third-generation ALK/ROS1 tyrosine kinase inhibitor, loratinib can provide a new treatment option for patients with ROS1-positive advanced non-small cell lung cancer.
Dr. Jianxin Yang, chief medical officer of CStone Pharmaceuticals, said that at present, after the emergence of drug resistance in ROS1-positive NSCLC patients, there is a lack of effective treatment. "We are delighted that loratinib has been approved to conduct a critical study in China for the treatment of ROS1-positive NSCLC patients. We will accelerate the clinical study of loratinib and bring more treatment options to patients as soon as possible. ”
It is worth noting that the study is a further deepening of the strategic cooperation between CStone and Pfizer. In September 2020, CStone and Pfizer reached a strategic partnership that includes a framework for cooperation to introduce more oncology products to the Greater China region. In June 2021, CStone and Pfizer jointly announced that they will jointly develop loratinib in the Greater China region, conduct research on ROS1-positive NSCLC, and bring more treatment options to patients in the field of cancer.
[Reporter] Yan Huifang
【Author】 Yan Huifang
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