Innovent's limertinib approved in China for first-line lung cancer

Innovent Biologics (HKEX: 1801) announced that its third-generation EGFR TKI, limertinib, has been approved by China's National Medical Products Administration (NMPA) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations. The approval was based on positive results from a Phase 3 clinical trial involving 337 treatment-naïve patients. Data showed a significant increase in median progression-free survival (PFS) with limertinib compared to gefitinib (20.7 months vs. 9.7 months), representing a 56% reduction in disease progression or death (HR 0.44; 95% CI: 0.34-0.58; p < 0.0001). Notably, patients with central nervous system lesions at baseline also saw significantly longer CNS PFS with limertinib (20.7 months vs. 7.1 months), indicating a 72% risk reduction for CNS progression or death (HR 0.28; 95% CI: 0.10-0.82; p = 0.0136). In October 2024, Innovent and Jiangsu Aosaikang Pharmaceutical Co. Ltd. entered into a commercial collaboration agreement regarding limertinib in China.