HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the National Medical Products Administration (NMPA) has approved another indication for its Orpathys (savolitinib). This approval means that the MET inhibitor can now be used to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alteration. This follows the conversion of the conditional approval into a full NMPA nod for its use in previously treated patients. The new label extension allows Orpathys to cover both treatment-naïve and previously treated patients in China.
NMPA Approval Based on Phase IIIb Study Results
The NMPA’s endorsement was based on results from the confirmatory Phase IIIb study in patients with MET exon 14 skipping alteration NSCLC. Specifically, in treatment-naïve patients, the drug achieved a 62.1% objective response rate (ORR) and a 92.0% disease control rate (DCR), with a median duration of response (DoR) of 12.5 months. The median progression-free survival (PFS) was 13.7 months, and the median overall survival (OS) was not reached with a median follow-up of 20.8 months. In previously treated patients, the ORR, DCR, and median DoR were 39.2%, 92.4%, and 11.1 months, respectively. The median PFS was 11.0 months, and the median OS was not mature with a median follow-up of 12.5 months. Responses occurred early (time to response 1.4-1.6 months) in both treatment-naïve and previously treated patients. The drug also demonstrated a tolerable safety profile, with no new safety signals observed.
Strategic Implications
The expanded approval of Orpathys for NSCLC with MET exon 14 skipping alteration highlights HutchMed’s commitment to addressing significant unmet medical needs in lung cancer. By covering both treatment-naïve and previously treated patients, Orpathys is now positioned to benefit a broader patient population in China. This approval is expected to enhance HutchMed’s market presence in the oncology space and contribute to the improved treatment outcomes for patients with NSCLC.-Fineline Info & Tech
