HUTCHMED has announced that new clinical data for several of its investigational compounds will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 – June 3, 2025, in Chicago.
The presentations will feature data from multiple studies of HUTCHMED-discovered compounds, including savolitinib, ranosidenib (HMPL-306), fruquintinib, and surufatinib, highlighting the company's expanding oncology pipeline.
SACHI Phase III Trial Results for Savolitinib
A late-breaking oral presentation will showcase results from the SACHI China Phase III study evaluating savolitinib in combination with osimertinib in patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC) with MET amplification after disease progression on EGFR inhibitor therapy.
The study met its pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. This data supports HUTCHMED's New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China.
Additional Savolitinib Data in NSCLC
Further data from the SAVANNAH Phase II study will also be presented, focusing on a high MET overexpression and/or amplification treatment subset. The analysis, stratified by brain metastasis status, showed that the savolitinib and osimertinib combination demonstrated better efficacy outcomes compared to savolitinib plus placebo.
Notably, the combination showed promising central nervous system (CNS) activity, with reduced CNS progression and fewer new CNS lesions, suggesting potential benefits for patients with brain metastases.
Ranosidenib: Novel Dual IDH1/2 Inhibitor
Results from the dose-escalation stage of the Phase I study of ranosidenib (HMPL-306) will be presented. This novel, small-molecule, highly selective oral dual-inhibitor of both Isocitrate dehydrogenase (IDH) 1 and IDH2 enzymes is being studied in patients with locally advanced or metastatic solid tumors with IDH mutations.
The compound demonstrated favorable tolerability, showing target inhibition and durable responses. In the efficacy-evaluated group of lower-grade glioma patients (N=14), ranosidenib achieved an objective response rate (ORR) of 7.1% and a disease control rate (DCR) of 100%, suggesting potential utility in this difficult-to-treat patient population.
Fruquintinib in Endometrial Cancer
The FRUSICA-1 study evaluated fruquintinib plus sintilimab in previously treated advanced endometrial cancer patients with proficient mismatch repair (pMMR) status. Subgroup analyses revealed clinically meaningful efficacy in patients with serous carcinoma (N=27), with an Independent Review Committee (IRC)-assessed ORR of 37.0% and a DCR of 88.9%.
Additional analysis showed that responses were durable and clinically meaningful regardless of whether patients had received prior neoadjuvant/adjuvant chemotherapy (NACT/ACT). Results were comparable for patients with and without prior NACT/ACT, with an IRC-assessed ORR of 34.0% versus 31.4% and DCR of 85.1% versus 82.4%, respectively.
Fruquintinib Safety Profile in Colorectal Cancer
Results from two subgroup analyses of a Phase IV study of fruquintinib involving 2,798 colorectal cancer patients in China will be presented. The analyses evaluated the safety of fruquintinib as monotherapy and in combination therapy, as well as its safety profile across different age groups.
Fruquintinib demonstrated a manageable safety profile in both monotherapy and combination therapy groups. Treatment-emergent adverse events (TEAE) of Grade 3 or above occurred in 23.94% of patients in the fruquintinib monotherapy group and 26.06% in the combination therapy group.
The most common treatment-related adverse events (TRAE) of any grade in both groups were palmar-plantar erythrodysesthesia (PPES) and hypertension. Notably, the combination therapy group exhibited a longer treatment duration, potentially indicating improved patient outcomes.
In the age-based subgroup analysis, the safety profile was comparable between younger (age <50) and late-elderly (age ≥75) patients, with younger patients receiving more intensive treatment. Combination therapy with fruquintinib also showed a longer duration than monotherapy in both age subgroups, suggesting potential survival benefits.
Additional Presentations
The ASCO meeting will also feature numerous investigator-initiated studies of HUTCHMED compounds, including:
- Fruquintinib in combination with camrelizumab, paclitaxel liposome, and nedaplatin for advanced esophageal squamous cell carcinoma
- Fruquintinib combined with PD-1 inhibitors and chemotherapy for HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma
- Surufatinib plus paclitaxel for advanced gastric cancer
- Surufatinib in combination with KN046 and chemotherapy for advanced pancreatic cancer
These presentations highlight HUTCHMED's ongoing commitment to developing novel targeted therapies for cancer patients with significant unmet medical needs.
Significance for Clinical Practice
The data being presented at ASCO 2025 demonstrate HUTCHMED's progress in developing targeted therapies across multiple tumor types. The positive results from the SACHI Phase III trial could potentially establish a new standard of care for EGFR-mutant NSCLC patients with MET amplification who have progressed on EGFR inhibitor therapy.
Similarly, the promising efficacy of fruquintinib plus sintilimab in endometrial cancer patients with pMMR status represents an important advancement for a patient population with limited treatment options. The safety analyses across different age groups and in combination regimens provide valuable information for clinical decision-making in real-world settings.
The early but encouraging results for ranosidenib in IDH-mutant solid tumors, particularly lower-grade gliomas, suggest potential for this novel dual IDH1/2 inhibitor in an area of high unmet need.
