Savolitinib and Osimertinib Show Improved Outcomes in Lung Cancer
Significant Findings from the SACHI Phase III Study
HUTCHMED reported compelling results from the SACHI Phase III study, which evaluated savolitinib and osimertinib for advanced EGFR mutation-positive non-small cell lung cancer (NSCLC) patients who progressed after first-line EGFR inhibitor therapy. The interim analysis indicated a significant progression-free survival (PFS) advantage, with the combination achieving a median PFS of 8.2 months compared to 4.5 months for chemotherapy. The safety profile was favorable, as no new adverse events were reported. These findings were presented at the ASCO Annual Meeting, and a subsequent webcast is scheduled. This study lays the groundwork for a New Drug Application (NDA), which has been accepted and prioritized for review in China.
Potential Advantages of the Treatment
- The savolitinib and osimertinib combination resulted in a median PFS of 8.2 months, significantly surpassing the 4.5-month PFS from chemotherapy (hazard ratio 0.34; p < 0.0001), showcasing a strong clinical benefit.
- With no new safety signals, the combination presents as a well-tolerated treatment option for patients.
- The study achieved its primary endpoint of PFS in the interim analysis, prompting successful enrollment completion and affirming treatment efficacy.
- The accepted NDA positions the company favorably in the market for this crucial treatment area, following priority review by the NMPA in China.
Challenges Ahead
- Current overall survival data remains immature, raising questions about the treatment’s long-term effectiveness.
- The press release stresses that regulatory approval is still needed, as the treatment is under clinical evaluation and not yet broadly accessible.
- Uncertainties surrounding the future prospects of savolitinib and its approval process could sway investor confidence.
Frequently Asked Questions
What is the SACHI Phase III study?
This study assesses savolitinib and osimertinib in EGFR mutation-positive NSCLC patients after they have undergone EGFR inhibitor therapy.
What key results emerged from the SACHI study?
The study demonstrated improved median PFS with savolitinib and osimertinib compared to chemotherapy and confirmed a favorable safety profile.
When is the webcast discussing SACHI findings?
The webcast will take place at 8:30 am HKT on June 3, 2025, to further elaborate on the ASCO data.
Why is the savolitinib and osimertinib combination significant?
This combination offers an effective, chemotherapy-free treatment option for patients with advanced NSCLC following previous therapies.
Has savolitinib received regulatory approval?
Yes, savolitinib is approved in China and marketed as ORPATHYS® for specific advanced NSCLC cases.
$HCM Hedge Fund Activity
Nineteen institutional investors adjusted their holdings in $HCM during the last quarter. Here are some notable transactions:
- UBS GROUP AG divested 161,163 shares (-42.7%) in Q1 2025, totaling approximately $2,423,891.
- JANE STREET GROUP, LLC increased its stake by adding 124,771 shares (+128.0%), valued at around $1,876,555.
- ALLIANZ ASSET MANAGEMENT GMBH sold 117,521 shares (-10.5%), equating to approximately $1,767,515.
- MILLENNIUM MANAGEMENT LLC reduced its position by 99,058 shares (-47.3%), worth about $1,489,832.
- SCHRODER INVESTMENT MANAGEMENT GROUP added 74,572 shares (+2.7%), estimated at $1,121,562.
- XY CAPITAL LTD increased its holdings with 66,460 shares (+142.4%), valued at approximately $999,558.
- BLACKROCK, INC. expanded their portfolio by 57,707 shares (+369.9%), totaling around $867,913.
Full Release
The all-oral chemotherapy-free combination of savolitinib plus osimertinib demonstrated significant PFS benefit with a favorable safety profile in the SACHI Phase III China study.
A webcast will be held at 8:30 am HKT on Tuesday, June 3, to discuss the data presented.
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 02, 2025 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) announces interim results from the SACHI Phase III study, presented in a late-breaking oral session on June 1, 2025, at the ASCO Annual Meeting in Chicago, USA.
The SACHI Phase III study investigates the combination of savolitinib and osimertinib for patients with locally advanced or metastatic EGFR mutation-positive NSCLC exhibiting MET amplification after progressing on first-line EGFR inhibitor therapy (clinicaltrials.gov identifier NCT05015608).
# Breakthrough Data on Savolitinib for Lung Cancer Presented at ASCO 2025
### Event Overview
**Date & Time:**
Sunday, June 1, 2025, 8:00 AM Central Daylight Time
**Location:**
Arie Crown Theater
### Key Study Findings
Prof. Shun Lu, Chief of the Shanghai Lung Cancer Center, announced significant results from the SACHI Phase III study. The combination of savolitinib and osimertinib shows marked effectiveness in treating EGFR mutation-positive non-small cell lung cancer (NSCLC) with MET amplification, particularly in patients previously treated with EGFR inhibitors. This approach offers a viable chemotherapy-free option, addressing urgent patient needs.
### Webcast Details
HUTCHMED will host a webcast discussing the SACHI study results during the ASCO Annual Meeting on Tuesday, June 3, 2025, from 8:30 to 9:00 AM HKT. The session will be in English and accessible via [www.hutch-med.com/event](http://www.hutch-med.com/event). A replay will follow shortly after the event.
### Interim Analysis Results
As of the interim analysis cut-off on August 30, 2024, 211 patients were randomized between the savolitinib + osimertinib and chemotherapy groups. Median progression-free survival (PFS) assessed by investigators was 8.2 months for the combination compared to 4.5 months for chemotherapy (hazard ratio [HR] 0.34; p < 0.0001). Independent reviews reported median PFS of 7.2 months for the combination versus 4.2 months for chemotherapy (HR 0.40; p < 0.0001).
### Additional Efficacy Data
The objective response rate (ORR) was 58% in the combination group, compared to 34% in chemotherapy. Disease control rate (DCR) further highlighted efficacy, standing at 89% for the savolitinib group against 67% for chemotherapy, with median duration of response (DoR) at 8.4 months versus 3.2 months.
### Safety Profile
The combination therapy had a tolerable safety profile with no new safety signals. Grade 3 or higher treatment-emergent adverse events occurred in 57% of patients for both treatment groups, indicating comparable safety.
### Study Status and Regulatory Developments
In January 2025, the Independent Data Monitoring Committee confirmed that SACHI met its primary endpoint of PFS, prompting the end of patient enrollment. A New Drug Application for savolitinib and osimertinib has been accepted for priority review by the China National Medical Products Administration for patients with advanced EGFR mutation-positive NSCLC following prior treatment failure.
### About Savolitinib
Savolitinib is an oral MET tyrosine kinase inhibitor showing efficacy in advanced solid tumors. It blocks aberrant activation of MET associated with mutations and amplifications that contribute to cancer progression. Approved in China under the name ORPATHYS®, it is in clinical trials for various cancers.
### About HUTCHMED
HUTCHMED is a biopharmaceutical company focused on developing targeted therapies for cancer and immunological conditions. Its commercial offerings include successful drug candidates that originated from in-house discoveries. Further information is available at [www.hutch-med.com](http://www.hutch-med.com).
### Forward-Looking Statements Disclaimer
This release contains forward-looking statements regarding HUTCHMED's expectations on the future development of savolitinib and related studies, addressing potential risks and uncertainties associated with clinical trials.# HUTCHMED Faces Risks in Savolitinib Development and Approval Process
### Key Risks Identified in Savolitinib Development
HUTCHMED has highlighted several risks associated with savolitinib, including regulatory requirements and potential safety issues. The success of the drug depends on meeting primary and secondary endpoints in clinical studies and achieving regulatory approval across various jurisdictions.
### Dependence on Combination Therapies
The development of savolitinib may also hinge on its use with other drugs, such as osimertinib. This introduces uncertainties related to their combined safety, efficacy, supply stability, and regulatory status.
### Investor Cautions and Risk Disclosure
Investors are advised not to overly rely on forward-looking statements as they are based on assumptions that could change. For detailed discussion regarding these risks, HUTCHMED refers to its filings with regulatory bodies like the US Securities and Exchange Commission and the Stock Exchange of Hong Kong.
### Product Availability Notice
This press release discusses products that might not be available in all markets. The information should not be viewed as promotional materials for drugs under development.
### Contact Information
For investor inquiries:
- **Phone**: +852 2121 8200
- **Email**: [email protected]
Media inquiries can be directed to:
- **FTI Consulting**: +44 20 3727 1030, [email protected]
- **Brunswick - Zhou Yi**: +852 9783 6894, [email protected]
### Financial Advisors
- **Panmure Liberum**: +44 20 7886 2500
- **HSBC**: +44 20 7991 8888
- **Cavendish**: +44 20 7220 0500
For further details, refer to HUTCHMED's complete filings.
