HUTCHMED's ORPATHYS®: A Game Changer in MET Exon 14 NSCLC Treatment

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Jan. 14, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the supplemental New Drug Application for ORPATHYS® (savolitinib) has been granted full approval by the China National Medical Products Administration (“NMPA”) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with MET exon 14 skipping alteration. This approval expands the label indication to include both treatment-naïve and previously treated patients in China, marking a significant milestone in the fight against this challenging form of lung cancer.

The approval by the NMPA was based on data from the confirmatory Phase IIIb clinical trial in patients with MET exon 14 skipping alteration NSCLC (NCT04923945). Preliminary efficacy and safety data from the first-line cohort were presented during the IASLC World Conference on Lung Cancer (WCLC) in September 2023, while final data from the confirmatory Phase IIIb trial were presented at the European Lung Cancer Congress in March 2024.

In treatment-naïve patients, objective response rate (“ORR”) was 62.1%, disease control rate (“DCR”) was 92.0%, and median duration of response (“DoR”) was 12.5 months, as assessed by an independent review committee. Median progression free survival (“PFS”) was 13.7 months, and median overall survival (“OS”) was not reached with median follow-up of 20.8 months. In previously treated patients, ORR was 39.2%, DCR was 92.4%, and median DoR was 11.1 months. Median PFS was 11.0 months, and median OS was not mature with 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 safety profile was tolerable, with no new safety signals observed. The most common drug-related treatment-emergent adverse events of Grade 3 or above (5% or more of patients) were abnormal hepatic function (16.9%), increased alanine aminotransferase (14.5%), increased aspartate aminotransferase (12.0%), peripheral oedema (6.0%), and increased gamma-glutamyltransferase (6.0%).

This full approval of ORPATHYS® reinforces its position as a transformative option for the treatment of biomarker-driven lung cancer, expanding its reach to both first-line and second-line patients in China with advanced NSCLC with MET exon 14 skipping alterations. The impressive results from the confirmatory Phase IIIb trial, along with the early onset of responses, underscore the potential of ORPATHYS® as a standard treatment option for this challenging patient population.



The expanded label indication for ORPATHYS® has the potential to significantly impact HUTCHMED's market position in China's lung cancer treatment landscape. As the first selective MET inhibitor approved in China, ORPATHYS® is well-positioned to capture a larger share of the market for first-line treatments in NSCLC with MET exon 14 skipping alterations. This could lead to increased market competition and potentially higher sales. Additionally, the inclusion of ORPATHYS® in the National Reimbursement Drug List (NRDL) for the treatment of locally advanced or metastatic NSCLC adult patients with MET exon 14-skipping alterations may increase its market penetration and sales.

In conclusion, the full approval of ORPATHYS® by the NMPA marks an exciting step forward in addressing the unmet needs of NSCLC patients with MET exon 14 skipping alteration. It not only validates HUTCHMED's research but also emphasizes the company's dedication to addressing unmet medical needs through targeted drug development. With the expanded label indication, ORPATHYS® has the potential to significantly impact HUTCHMED's market position in China's lung cancer treatment landscape, expanding the reach of this innovative therapy to even more patients with this form of lung cancer.