HUTCHMED (00013) announced that VIKORY has received regular approval from the China National Medical Products Administration for the treatment of locally advanced or metastatic MET exon 14 skipping non-small cell lung cancer.

HUTCHMED (00013) announced that the new indication marketing application for ORPATHYS (savolitinib, or savolitinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations has been approved by the China National Medical Products Administration. The National Medical Products Administration has also converted the conditional approval of ORPATHYS in previously treated patients to regular approval. The new indication for ORPATHYS in China will now cover both treatment-naive and previously treated patients. This approval by the National Medical Products Administration is based on data from a phase IIIb confirmatory study conducted in patients with MET exon 14 skipping non-small cell lung cancer (NCT04923945). The preliminary efficacy and safety data from the first-line treatment cohort of the study were presented at the World Conference on Lung Cancer (WCLC) in September 2023. The final data from the study were presented at the European Lung Cancer Conference (ELCC) in March 2024. In treatment-naive patients, the independently reviewed objective response rate (ORR) was 62.1%, disease control rate (DCR) was 92.0%, and median duration of response (DoR) was 12.5 months. The median progression-free survival (PFS) at a median follow-up of 20.8 months was 13.7 months, and the median overall survival (OS) has not been reached. In previously treated patients, the independently reviewed ORR was 39.2%, DCR was 92.4%, and median DoR was 11.1 months. The median PFS at a median follow-up of 12.5 months was 11.0 months, and the median OS has not matured. Both treatment-naive and previously treated patients showed early responses (time to response 1.4-1.6 months). The safety profile was tolerable, with no new safety signals observed. The most common grade 3 or higher treatment-related adverse events (in 5% or more of patients) were abnormal liver function (16.9%), elevated alanine transaminase (14.5%), elevated aspartate transaminase (12.0%), peripheral edema (6.0%), and elevated gamma-glutamyl transferase (6.0%). Professor Lu Shun, Director of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, and the principal investigator of the phase IIIb confirmatory study for ORPATHYS, stated, "The phase IIIb confirmatory study of ORPATHYS is one of the largest phase III studies in this patient population in China to date. ORPATHYS has demonstrated clear efficacy and tolerability in both first-line and second-line treatment, highlighting its potential as a standard therapy for MET exon 14 skipping non-small cell lung cancer. With the approval of ORPATHYS for first-line treatment, we can offer this effective treatment to patients at an earlier stage of treatment. We look forward to bringing this new therapy to patients and further optimizing its treatment strategy for this challenging disease to improve patient outcomes and quality of life." Dr. Ming Shi, Chief Medical Officer of HUTCHMED, stated, "This approval is an important step forward in addressing the unmet medical needs of patients with MET exon 14 skipping non-small cell lung cancer. The approval not only recognizes our research but also underscores our commitment to developing drugs targeting unmet medical needs. We are dedicated to advancing research and expanding the accessibility of ORPATHYS in the hope of improving the treatment of this challenging lung cancer. At the same time, we will continue to explore the application of ORPATHYS in other MET-driven diseases to help more patients who may benefit from this targeted therapy." Ms. Guan Dongmei, General Manager of the Oncology Business at AstraZeneca China, said, "This approval further solidifies the transformative position of ORPATHYS in treating this subgroup of patients with biomarker-driven lung cancer. It is gratifying to see that we can now offer first-line and second-line treatment options for patients in China with advanced non-small cell lung cancer who have MET exon 14 skipping mutations. Through our collaboration with HUTCHMED, we are advancing the use of ORPATHYS for addressing resistance to EGFR-TKIs, opening up new possibilities for the treatment of MET-mutated and amplified cancers, and expanding the coverage of this innovative therapy to more patients with this type of lung cancer." Savolitinib is the first selective MET inhibitor approved in China, launched and marketed under the brand name ORPATHYS by the company's partner AstraZeneca for this patient population.