Innovent and ASK Pharm Receive Approval for Limertinib in the Treatment of Lung Cancer
Monday, April 28, 2025
Innovent Biologics in collaboration with ASK Pharm, has announced that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for limertinib.
Lung cancer remains a leading cause of cancer-related deaths worldwide, with non-small cell lung cancer (NSCLC) accounting for around 85% of all cases. Most NSCLC patients are diagnosed at locally advanced or metastatic stages, where surgery is not a viable option.
EGFR mutations are especially common among Asian NSCLC patients, found in around 30% to 50% of cases. Third-generation EGFR tyrosine kinase inhibitors (TKIs) are considered the standard of care for these patients due to their broad therapeutic coverage.
Limertinib is an oral, third-generation EGFR TKI developed by Innovent. It is approved by the NMPA for:
- The treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated NSCLC who have progressed after prior EGFR TKI therapy.
- The first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations.
The treatment is now authorised as a first-line therapy for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR exon 19 deletions or exon 21 L858R mutations. The two companies entered a commercial collaboration agreement for limertinib in Mainland China in 2024.
The approval is based on results from a Phase 3 clinical trial involving 337 patients newly diagnosed with EGFR mutation-positive locally advanced or metastatic NSCLC.
The trial showed that limertinib significantly extended median PFS compared to gefitinib, reaching 20.7 months versus 9.7 months. This represented a 56% reduction in the risk of disease progression or death.
The safety profile of limertinib was similar to that of other EGFR-targeted therapies. Adverse events were mainly mild to moderate and well tolerated, with no new safety concerns identified.
ASK Pharm is also advancing clinical research combining limertinib with ASKC202, a cMET inhibitor, for NSCLC patients resistant to third-generation EGFR-TKIs.
Source: innoventbio.com
