Innovent and ASK Pharm Announce Approval of Limertinib for Lung Cancer Treatment
Friday, January 17, 2025
Innovent Biologics and Jiangsu Aosaikang Pharmaceutical (ASK Pharm) have announced that the National Medical Products Administration (NMPA) in China has approved the New Drug Application (NDA) for limertinib.
Limertinib is an orally administered, third-generation EGFR tyrosine kinase inhibitor designed to address the T790M resistance mutation. It has been approved for patients with advanced or metastatic EGFR T790M-mutated NSCLC.
Regulatory review is also underway for its use as a first-line treatment in patients with EGFR exon 19 deletions or exon 21 L858R mutations.
Lung cancer is one of the leading causes of cancer-related deaths worldwide, with non-small cell lung cancer (NSCLC) accounting for the majority of cases. Approximately 70% of NSCLC cases are diagnosed at advanced stages.
EGFR mutations, particularly common in Asian populations, are found in 30–50% of these cases. Third-generation EGFR TKIs like limertinib offer targeted treatment options for these patients.
The drug is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying the EGFR T790M mutation.
This approval expands Innovent's portfolio to 14 commercialised products and enhances its targeted therapy offerings for lung cancer.
A Phase 2b study involving 301 patients with EGFR T790M-mutated NSCLC demonstrated promising results. The trial reported an overall response rate (ORR) of 68.8%, a disease control rate (DCR) of 92.4%, and a median progression-free survival (PFS) of 11.0 months.
For patients with central nervous system (CNS) involvement, the CNS ORR was 65.9%, with a median PFS of 10.6 months. The safety profile was consistent with other EGFR inhibitors.
Limertinib also achieved its primary endpoint in a Phase 3 trial comparing it to gefitinib as a first-line treatment for advanced NSCLC with EGFR-sensitive mutations. A separate NDA for this first-line indication is currently under review by the NMPA.
ASK Pharm is also investigating the potential of limertinib in combination with ASKC202, a selective c-Met inhibitor, for patients with resistance to third-generation EGFR TKIs.
This approval highlights significant progress in Innovent and ASK Pharm’s commitment to developing innovative therapies for cancer treatment in China.
Source: prnewswire.com
