Zhitong Finance App News, Hehuang Pharmaceutical (00013) announced that the marketing application for sevotinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with locally advanced or metastatic non-small cell lung cancer with interstitium-epithelial conversion factor (MET) exon 14 transitions has been accepted by the China Drug Administration. If approved, the new labeling indication for sevolitinib in China will be extended to cover first-time patients.

According to reports, sevolitinib has previously been conditionally approved in China to treat patients with non-small cell lung cancer with MET exon 14 jumping mutations whose disease progresses after receiving systemic treatment or who are unable to receive chemotherapy. Sevotinib is the first selective MET inhibitor approved in China, and the company's partner AstraZeneca targets this patient group under the trade name Vorosha (ORPATHYS) Market and sell it. The number of lung cancer patients in China accounts for more than one-third of the total number of lung cancer patients in the world. About 2%-3% of patients with non-small cell lung cancer worldwide have MET exon 14 jumping mutations.

Preliminary efficacy and safety data for the Phase IIIb Confirmatory Study (NCT04923945) first-line treatment cohort were presented at the World Lung Cancer Congress (WCLC) hosted by the International Association for Lung Cancer Research (IASLC) in September 2023. The final data from this phase IIIb confirmatory study were presented at the European Lung Cancer Congress on March 20, 2024.

The data from this study provided confirmatory evidence that sevotinib is the primary treatment of MET exon jumping mutations and as a targeted treatment option for patients with non-small cell lung cancer treated. Among first-time patients, the independent review committee assessed an objective response rate (ORR) of 62.1% [95% confidence interval (CI): 51.0% to 72.3%], disease control rate (DCR) of 92.0% (95% CI: 84.1% to 96.7%), and a median duration of remission (DoR) of 12.5 months (95% CI: 8.3 to 15.2 months). The median progression-free survival (PFS) to a median follow-up of 20.8 months was 13.7 months (95% CI: 8.5 months to 16.6 months), and the median overall survival (OS) was not achieved. Among treated patients, the independent review committee assessed an ORR of 39.2% (95% CI: 28.4% to 50.9%), a DCR of 92.4% (95% CI: 84.2% to 97.2%), and a median DoR of 11.1 months (95% CI: 6.6 months to not achieved). The median PFS to a median follow-up of 12.5 months was 11.0 months (95% CI: 8.3 to 16.6 months) and the median OS was immature. Both initial and treated patients experienced early remission (time to reach remission of disease 1.4-1.6 months). The safety features were tolerable, and no new safety signals were observed. The most common grade 3 or above drug-related adverse events (5% or more patients) were abnormal liver function (16.9%), elevated alanine aminotransferase (14.5%), elevated alanine aminotransferase (12.0%), peripheral oedema (6.0%), and elevated gamma-glutamyltransferase (6.0%).