China-based Innovent Biologics, Inc. (HKG: 1801) has announced that it has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its limertinib. This third-generation EGFR TKI has been approved for use in adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). This approval represents a significant advancement in the treatment options available for patients with this specific type of lung cancer.
Pivotal Phase IIb Study Results
The pivotal Phase IIb study for limertinib, involving 301 patients with locally advanced or metastatic EGFR T790M-mutated NSCLC, demonstrated the drug’s robust efficacy and safety profile. Specifically, limertinib achieved an overall response rate (ORR) of 68.8% and a disease control rate (DCR) of 92.4%, as assessed by the Independent Review Committee (IRC). The median progression-free survival (PFS) was 11.0 months, and the median duration of response (DoR) was 11.1 months. In patients with assessable central nervous system (CNS) lesions (N=99), the CNS best-ORR was 65.9% with a median PFS of 10.6 months. The safety profile of limertinib was comparable to other EGFR-targeting agents in its class.
Additional Market Filing Under Review
In addition to the approved indication, another market filing for limertinib is currently under review by the NMPA. This filing, licensed from compatriot firm Jiangsu Aosaikang Pharmaceutical Co. Ltd. (SHE: 002755) via a deal in October of last year, is for the first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations. This further expansion of limertinib’s indications highlights Innovent’s commitment to addressing the diverse needs of patients with NSCLC.
Strategic Implications
The NDA approval of limertinib by the NMPA is a strategic milestone for Innovent Biologics. It underscores the company’s dedication to advancing innovative treatments for lung cancer and enhancing patient outcomes. By securing approval for this third-generation EGFR TKI, Innovent 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
