Surufatinib + KN046 in 1L PDAC - Better response and safety, with still-maturing mPFS competitive against SoC (link), albeit small samples (n=16, link). IBI363 +/- beva in MSS/pMMR CRC - Continues to demonstrate next-gen IO potential, with consistent ORR in larger samples (12.7%/23.5% +/- beva), and potential best-in-class mDoR of 7.5m/NR and mOS 16.1m/NR for monotherapy and combination therapy, respectively (link). See inside for peer data comparison. May 23, 2025 12:06 AM GMT China Healthcare | Asia Pacif ...

Core Insights - HUTCHMED is set to present new data on its compounds at the ASCO Annual Meeting from May 30 to June 3, 2025, in Chicago, USA [1] Group 1: Savolitinib - The SACHI Phase III study results of savolitinib in combination with osimertinib for EGFR mutation-positive NSCLC will be presented, showing that it met the primary endpoint of progression-free survival (PFS) [2] - Additional data from the SAVANNAH Phase II study indicates that the combination of savolitinib and osimertinib showed better efficacy outcomes compared to savolitinib plus placebo, with promising CNS activity [3] Group 2: Ranosidenib - Results from the Phase I study of ranosidenib (HMPL-306) indicate it was well tolerated, with target inhibition and durable responses, particularly in lower-grade glioma patients, showing an objective response rate (ORR) of 7.1% and a disease control rate (DCR) of 100% [4] Group 3: Fruquintinib - The FRUSICA-1 Phase II study results for fruquintinib plus sintilimab in advanced endometrial cancer patients showed an ORR of 37.0% and a DCR of 88.9%, with durable responses regardless of prior chemotherapy [5] - A Phase IV study involving 2,798 colorectal cancer patients demonstrated a manageable safety profile for fruquintinib, with Grade 3 or above treatment-emergent adverse events occurring in 23.94% for monotherapy and 26.06% for combination therapy [6]

Company Overview - HUTCHMED (China) Limited is an innovative, commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [12]. Recent Developments - HUTCHMED announced new and updated data from studies of its compounds, including savolitinib, fruquintinib, and surufatinib, which will be presented at the American Association of Cancer Research (AACR) Annual Meeting 2025 [1]. - The company is actively involved in multiple clinical trials, including the SACHI and SAFFRON trials, assessing the combination of savolitinib with TAGRISSO® (osimertinib) for treating patients with advanced non-small cell lung cancer (NSCLC) [10][11]. Product Information - Savolitinib is a selective MET tyrosine kinase inhibitor developed by HUTCHMED and AstraZeneca, approved in China for treating adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alterations [7][6]. - Fruquintinib is being studied in various treatment regimens for metastatic colorectal cancer (mCRC), with ongoing trials evaluating its efficacy in combination with other therapies [2][3]. Market Context - Lung cancer is the leading cause of cancer death globally, with NSCLC accounting for approximately 80% of cases. A significant portion of NSCLC patients in Asia have epidermal growth factor receptor (EGFR) mutations, which are targetable by therapies like savolitinib [4][5]. - The prevalence of MET aberrations in NSCLC patients who progress after EGFR TKI treatment is notable, with studies indicating that 15-50% of these patients may present with such mutations [8][9]. Clinical Trial Highlights - The SACHI trial met its primary endpoint of progression-free survival (PFS) during its interim analysis, leading to the acceptance of a New Drug Application (NDA) in China [10]. - The SAFFRON trial is ongoing, assessing the combination of savolitinib and TAGRISSO® against platinum-based chemotherapy in a specific patient population [11]. Future Prospects - HUTCHMED is focused on expanding the clinical development of its compounds, with promising data from ongoing trials expected to support potential regulatory filings in the US and other global markets [9][11].