Jiangsu Aosaikang Pharmaceutical Co., Ltd (ASK Pharm, SHE: 002755) has recently received approval from the National Medical Products Administration (NMPA) for the registration and market launch of its drug Limertinib (Brand name: Aoyixing). The drug is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after EGFR-TKI therapy and have been confirmed to have EGFR T790M mutation positivity.
Clinical Trial Results
In the key Phase IIb clinical study for Limertinib in treating EGFR T790M mutation-positive NSCLC, a total of 301 patients with locally advanced or metastatic NSCLC who had progressed after EGFR-TKI treatment were enrolled. The objective response rate (ORR) assessed by the Independent Review Committee (IRC) was 68.8%, and the disease control rate (DCR) was 92.4%. The median duration of response (DoR) was 11.1 months, and the median progression-free survival (PFS) was 11.0 months. Among patients with assessable central nervous system (CNS) lesions, the best ORR assessed by IRC was 65.9%, with a median PFS of 10.6 months, indicating good efficacy of Limertinib in CNS patients. The safety profile of Limertinib was consistent with previously reported EGFR TKI inhibitors, showing good tolerability.
Additional Market Application
Furthermore, the Phase III clinical trial of Limertinib versus Gefitinib as first-line treatment for EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC has reached its primary endpoint. A second marketing application for Limertinib was accepted by the NMPA in August 2024 and is currently under review. This application is for the first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring epidermal growth factor receptor (EGFR) exon 19 deletions (19DEL) or exon 21 L858R mutations.
Strategic Implications
The approval of Limertinib by the NMPA is a significant milestone for Aosaikang Pharmaceuticals. It underscores the company’s commitment to advancing innovative treatments for lung cancer and enhancing patient outcomes. By securing approval for this third-generation EGFR TKI, Aosaikang is poised to make a significant impact on the treatment landscape for EGFR T790M-mutated NSCLC, potentially improving the standard of care for patients in China and beyond.-Fineline Info & Tech
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