NEW YORK – China's National Medical Products Administration (NMPA) has approved Hutchmed's MET inhibitor Orpathys (savolitinib) as a first-line treatment for locally advanced or metastatic non-small cell lung cancer patients with MET exon 14 skipping alterations, the company said on Tuesday.
The NMPA also converted the prior conditional approval of Orpathys for previously treated NSCLC patients with MET exon 14 skipping alterations to full approval, making the drug available in both the first- and second-line settings.
The approval was based on a Phase IIIb confirmatory trial that included both treatment-naïve and previously treated NSCLC patients. In treatment-naïve patients, the response rate on Orpathys was 62.1 percent and median progression-free survival was 13.7 months. In the previously treated group, the response rate was 39.2 percent and median progression-free survival was 11 months. In both cohorts, the median overall survival was not reached, with a follow-up of 20.8 months in treatment-naïve patients and 12.5 months in the previously treated cohort.
This month, Hutchmed submitted another application seeking approval in China for the combination of Orpathys and AstraZeneca's EGFR inhibitor Tagrisso (osimertinib) as a second-line treatment for patients with locally advanced or metastatic EGFR-positive NSCLC with MET amplification.
Hutchmed and AstraZeneca partnered in 2011 to develop Orpathys, with Hutchmed leading development and regulatory submissions in China and AstraZeneca responsible for development outside of China and commercialization worldwide. The firms are also studying Orpathys in MET-amplified, previously treated, advanced gastric cancer patients and with AstraZeneca's checkpoint inhibitor Imfinzi (durvalumab) in MET-driven advanced papillary renal cell carcinoma.