【News】The clinical trial of loratinib for ROS1-positive advanced NSCLC was approved in China

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Author: John

CStone's advantages in the field of precision therapy and immunotherapy are further highlighted, and after announcing the joint development of loratinib (former name: loratinib) with Pfizer, its key research on ROS1-positive NSCLC patients was approved by THE NMPA. Previously, Pfizer's loratinib has been approved by the FDA for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive and ALK-positive metastatic non-small cell lung cancer (NSCLC).

On January 4, CStone pharmaceuticals announced that its 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.

In a previous Phase I/II study, loratinib showed a deep and long-lasting objective response in PATIENTS1-positive advanced NSCLC who had not been treated with TKI or had failed TKI treatment. 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.

Loratinib is a potent and selective inhibitory third-generation ALK/ROS1 tyrosine kinase inhibitor (TKI) capable of penetrating the blood-brain barrier. With its excellent clinical data, loratinib has been approved in more than 50 countries around the world for the treatment of adult ALK-positive metastatic NSCLC patients.

Loratinib is developed and produced by Pfizer, which has a variety of functions and powerful effects. According to the clinical data of loratinib, for patients with different types of ALK+, the efficiency of first-line use of loratinib can reach up to 90%; for patients resistant to clozolitinib, the efficiency of continuing to use loratinib can be up to about 60%,; and for patients who are resistant to all three ALK inhibitors, the efficiency of loratinib can be as high as about 39%.

In March, the U.S. FDA approved Lorbrena (lorlatinib, loratinib) for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Lorbrena received accelerated approval in the U.S. in 2018 for patients treated with ALK-positive metastatic non-small cell lung cancer (NSCLC). The approval also translates the 2018 accelerated approval into full approval.

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 in which Pfizer will acquire a 9.90% stake in CStone (valued at US$200 million), including 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.