On August 31, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported positive high-level results from the SANOVO China Phase III trial in treatment-naïve patients with locally advanced or metastatic non-small cell lung cancer ("NSCLC") whose tumors harbor epidermal growth factor receptor ("EGFR") mutation and MET overexpression. ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival ("PFS") versus TAGRISSO alone in both the high MET and intention-to-treat ("ITT") patient populations.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In both patient populations, the combination also demonstrated a very encouraging clinical benefit in overall survival ("OS"), a secondary endpoint of the trial. The trial will continue to follow-up on these results. These data will be presented at a forthcoming medical meeting.

Professor Yi-Long Wu of the Guangdong Provincial People’s Hospital, and the leading Principal Investigator of the SANOVO trial, said: "Co-occurring MET overexpression in treatment-naïve EGFR-mutated NSCLC often compromises the long-term durability of EGFR-TKI monotherapy. The positive findings from SANOVO demonstrate that addressing both pathways upfront with an all-oral, biomarker-directed regimen offers a powerful new approach for these patients whose tumors have MET overexpression. By combining ORPATHYS with TAGRISSO, we have observed a clear clinical benefit that could reshape primary treatment strategy for this distinct patient population."

Dr Weiguo Su, Chief Executive Officer* and Chief Scientific Officer of HUTCHMED, said: "We are thrilled by the positive results from SANOVO, which validate our strategy of addressing MET-driven disease across multiple stages of lung cancer. Building on the strong foundations of our Phase III SAFFRON global study and SACHI study in China in pre-treated patients, SANOVO data further validate the therapeutic strength and versatility of the ORPATHYS and TAGRISSO combination in first-line patients. We are deeply grateful to all patients and investigators who participated in the trial, and we look forward to sharing the data with regulatory authorities to bring this innovative all-oral combination to the first-line setting in China."

Dr Jing He, Head of R&D China, AstraZeneca, said: "These positive data underscore the pivotal role of ORPATHYS in intercepting MET-driven resistance early in the treatment journey. By combining the targeted precision of ORPATHYS with backbone TAGRISSO, SANOVO demonstrates a meaningful clinical advancement for treatment-naïve patients with MET overexpression and EGFR mutation. Together with HUTCHMED, we are excited to advance ORPATHYS in China as a transformative, biomarker-directed addition to frontline lung cancer care."

The safety profile for ORPATHYS plus TAGRISSO was consistent with the known profiles of each medicine, and there were no new safety findings.

ORPATHYS plus TAGRISSO is approved in China for patients with locally advanced or metastatic EGFR‑mutated ("EGFRm") NSCLC with MET amplification after disease progression on EGFR-tyrosine kinase inhibitor ("TKI") therapy based on the SACHI Phase III trial. The combination also reported positive high-level results in the SAFFRON global Phase III trial in EGFRm NSCLC with MET overexpression or amplification after disease progression on TAGRISSO in August 2026, demonstrating a statistically significant and clinically meaningful improvement in both PFS and overall survival ("OS").

ORPATHYS is being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.

About NSCLC and MET aberrations
Lung cancer is the leading cause of death by cancer globally, accounting for almost one in four (23%) cancer deaths.1 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC.2 Approximately 75% of NSCLC patients are diagnosed with advanced disease.3 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFRm NSCLC.

MET is a tyrosine kinase receptor that has an essential role in normal cell development.7 MET overexpression or amplification can lead to tumor growth and the metastatic progression of cancer cells.

About SANOVO
SANOVO is a blinded, randomized, controlled Phase III study in previously untreated patients with locally advanced or metastatic NSCLC with activating EGFR mutations and MET overexpression in China. The study evaluates the efficacy and safety of ORPATHYS in combination with TAGRISSO comparing to TAGRISSO alone, a standard-of-care treatment option for these patients. A total of 326 treatment-naïve patients with locally advanced or metastatic NSCLC harboring EGFR mutations (exon 19 deletion or L858R) and MET overexpression were randomized in a 1:1 ratio to receive TAGRISSO 80 mg once daily plus either ORPATHYS or placebo at 300/200 mg twice daily (dosed based on body weight).

The primary endpoint of the study is PFS as assessed by investigators. Other endpoints include PFS assessed by an independent review committee, OS, objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. Additional details may be found at clinicaltrials.gov, using identifier NCT05009836.

About ORPATHYS
ORPATHYS (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

ORPATHYS is approved in China for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. ORPATHYS also received a conditional approval in China for the treatment of patients with locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments. ORPATHYS in combination with TAGRISSO is approved in China for patients with locally advanced or metastatic EGFR mutation-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy based on the SACHI Phase III trial. The combination was also granted a temporary authorization in Switzerland for the treatment of patients with locally advanced or metastatic EGFRm NSCLC and high levels of MET overexpression or amplification who progressed on prior treatment with TAGRISSO. This was based on results from the global SAVANNAH Phase II trial. The global, randomized, SAFFRON Phase III trial in the same treatment setting comparing the combination with platinum-based chemotherapy, reported positive high-level results demonstrating a statistically significant and clinically meaningful improvement in PFS and OS in August 2026.

About TAGRISSO
TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including the treatment of central nervous system metastases.

TAGRISSO is approved as monotherapy in more than 120 countries including the US, EU, China and Japan. Approved indications include for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, adjuvant treatment of early-stage EGFRm NSCLC and locally advanced, unresectable NSCLC following platinum-based chemoradiation therapy. TAGRISSO is also approved in combination with chemotherapy in more than 80 countries, including the US, EU, China and Japan, for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

(Press release, Hutchison China MediTech, AUG 31, 2026, View Source [SID1234670430])