Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) to conduct a single-arm pivotal Phase II clinical study. The study will focus on patients with ALK gene fusion-positive advanced non-small cell lung cancer (NSCLC) who have experienced disease progression or toxicity intolerance following treatment with second-generation anaplastic lymphoma kinase (ALK) inhibitors.
Development and Mechanism of the Drug
The Category 1 drug candidate is a third-generation ALK inhibitor designed to treat ALK-positive NSCLC that is resistant to first and second-generation ALK inhibitors. It demonstrates a strong inhibitory effect on wild-type ALK kinases and key drug-resistant mutants of the first/second-generation ALK inhibitors. This action blocks their signal transduction pathways, ultimately achieving effective inhibition of the growth of mutant tumors.
Previous Clinical Results and Future Outlook
In previous clinical studies, the drug has shown significant antitumor activity in patients with ALK inhibitor resistance, including resistance to first-generation and second-generation drugs. It was well tolerated, with a low incidence of drug-related adverse reactions, most of which were mild to moderate (grade 1-2). If the results of the Phase II study are as anticipated, a conditional market approval filing is expected, according to the announcement.-Fineline Info & Tech
