Core Insights - HUTCHMED has completed patient enrollment for the SAFFRON Phase III study, which investigates the combination of ORPATHYS and TAGRISSO for treating advanced non-small cell lung cancer (NSCLC) with specific genetic mutations [1][3][16] - The combination therapy is a promising chemotherapy-free, all-oral treatment option that has already received approval in China based on previous trial results [2][15] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on developing targeted therapies and immunotherapies for cancer and immunological diseases [18] - The company has successfully brought drug candidates from discovery to market, with its first three medicines approved in China and one also approved globally [18] Study Details - The SAFFRON study is a global, open-label, randomized trial involving 338 patients across 29 countries, aiming to assess the efficacy and safety of ORPATHYS in combination with TAGRISSO compared to traditional chemotherapy [3][4][16] - The primary endpoint of the study is progression-free survival (PFS), with additional endpoints including overall survival (OS) and objective response rate (ORR) [3][4] Market Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases, and a significant portion of patients exhibiting EGFR mutations [5][6] - The combination of ORPATHYS and TAGRISSO addresses resistance mechanisms in patients who have progressed on EGFR TKI therapy, with a notable percentage of these patients presenting with MET aberrations [14][15] Product Information - ORPATHYS (savolitinib) is a selective MET TKI approved in China for specific NSCLC patients, while TAGRISSO (osimertinib) is a third-generation EGFR TKI with proven efficacy in NSCLC [7][10][11] - The combination therapy has shown promising results in previous studies, leading to the initiation of multiple Phase III trials, including SAFFRON [14][15]
HUTCHMED Announces Enrollment Completed of SAFFRON Global Phase III Trial of ORPATHYS® and TAGRISSO® Combination for Certain Lung Cancer Patients with MET Overexpression and/or Amplification After Progression on TAGRISSO®