HUTCHMED Completes Patient Enrollment of SANOVO Phase III Trial of ORPATHYS® and TAGRISSO® Combination as a First-Line Therapy for Certain Lung Cancer Patients in China
HUTCHMED (NASDAQ:HCM) has completed patient enrollment for the SANOVO Phase III trial, evaluating the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) as a first-line treatment for non-small cell lung cancer (NSCLC) patients with EGFR mutation and MET overexpression in China.
The randomized, controlled study will compare the efficacy and safety of the combination therapy versus TAGRISSO® alone. The trial's primary endpoint is progression-free survival (PFS), with secondary endpoints including overall survival, objective response rate, and safety measures. Topline results are expected in the second half of 2026, potentially leading to a supplementary New Drug Application to China's NMPA.
HUTCHMED (NASDAQ:HCM) ha completato l'arruolamento dei pazienti per lo studio di fase III SANOVO, che valuta la combinazione di ORPATHYS® (savolitinib) e TAGRISSO® (osimertinib) come trattamento di prima linea per i pazienti cinesi con carcinoma polmonare non a piccole cellule (NSCLC) portatori di mutazione EGFR e sovraespressione di MET.
Lo studio randomizzato e controllato confronterà efficacia e sicurezza della terapia combinata rispetto a TAGRISSO® da sola. L'end point primario è la sopravvivenza libera da progressione (PFS), mentre gli end point secondari includono la sopravvivenza globale, il tasso di risposta obiettiva e gli indicatori di sicurezza. I risultati principali sono attesi nella seconda metà del 2026, con la possibilità di presentare una domanda supplementare di Nuovo Farmaco all'NMPA cinese.
HUTCHMED (NASDAQ:HCM) ha finalizado la inscripción de pacientes en el ensayo de fase III SANOVO, que evalúa la combinación de ORPATHYS® (savolitinib) y TAGRISSO® (osimertinib) como tratamiento de primera línea para pacientes chinos con cáncer de pulmón no microcítico (NSCLC) con mutación EGFR y sobreexpresión de MET.
El estudio aleatorizado y controlado comparará la eficacia y seguridad de la terapia combinada frente a TAGRISSO® en monoterapia. El endpoint primario es la supervivencia libre de progresión (PFS), y los endpoints secundarios incluyen la supervivencia global, la tasa de respuesta objetiva y las medidas de seguridad. Se esperan los resultados principales en la segunda mitad de 2026, lo que podría dar lugar a una solicitud suplementaria de Nuevo Fármaco ante la NMPA de China.
HUTCHMED (NASDAQ:HCM)는 중국에서 EGFR 변이 및 MET 과발현을 보이는 비소세포폐암(NSCLC) 환자 대상 1차 치료로서 ORPATHYS®(savolitinib)과 TAGRISSO®(osimertinib) 병용을 평가하는 SANOVO 3상 시험의 환자 등록을 완료했습니다.
이 무작위 대조 연구는 병용요법과 단독 TAGRISSO®의 효능 및 안전성을 비교합니다. 주요 평가변수는 무진행생존기간(PFS)이며, 2차 평가변수로 전체생존기간, 객관적 반응률 및 안전성 지표가 포함됩니다. 주요 결과는 2026년 하반기에 발표될 예정이며, 이는 중국 NMPA에 보완 신약 허가 신청으로 이어질 가능성이 있습니다.
HUTCHMED (NASDAQ:HCM) a terminé l'inclusion des patients dans l'essai de phase III SANOVO, qui évalue la combinaison ORPATHYS® (savolitinib) et TAGRISSO® (osimertinib) en traitement de première ligne chez des patients chinois atteints de cancer du poumon non à petites cellules (NSCLC) présentant une mutation EGFR et une surexpression de MET.
Cette étude randomisée et contrôlée comparera l'efficacité et la sécurité de la thérapie combinée versus TAGRISSO® en monothérapie. Le critère principal est la survie sans progression (PFS), les critères secondaires incluant la survie globale, le taux de réponse objective et les paramètres de sécurité. Les résultats principaux sont attendus au second semestre 2026, ce qui pourrait entraîner un dossier complémentaire d'autorisation de nouveau médicament auprès de la NMPA chinoise.
HUTCHMED (NASDAQ:HCM) hat die Rekrutierung der Patienten für die SANOVO Phase‑III‑Studie abgeschlossen, die die Kombination von ORPATHYS® (savolitinib) und TAGRISSO® (osimertinib) als Erstlinienbehandlung bei chinesischen Patienten mit nicht‑kleinzelligem Lungenkrebs (NSCLC) mit EGFR‑Mutation und MET‑Überexpression untersucht.
Die randomisierte, kontrollierte Studie wird Wirksamkeit und Sicherheit der Kombinationsbehandlung mit TAGRISSO® als Monotherapie vergleichen. Der primäre Endpunkt ist das progressionsfreie Überleben (PFS); zu den sekundären Endpunkten zählen das Gesamtüberleben, die objektive Ansprechrate und Sicherheitsparameter. Die Topline‑Ergebnisse werden für die zweite Hälfte 2026 erwartet und könnten zu einem ergänzenden Zulassungsantrag bei der chinesischen NMPA führen.
- Completed enrollment for a significant Phase III trial in China
- Potential to improve standard-of-care treatment for NSCLC patients
- Strategic collaboration with AstraZeneca for development and commercialization
- Results not expected until second half of 2026
- Success of the trial and regulatory approval not guaranteed
Insights
HCM completes enrollment for pivotal SANOVO trial testing ORPATHYS®+TAGRISSO® combo in first-line EGFR-mutated NSCLC, with results expected H2 2026.
The completion of patient enrollment in HUTCHMED's SANOVO Phase III trial represents a significant milestone in the development pathway for ORPATHYS® (savolitinib) in combination with TAGRISSO® (osimertinib). This blinded, randomized controlled study is specifically targeting patients with locally advanced or metastatic NSCLC harboring both EGFR mutations and MET overexpression - a precise molecular subset of lung cancer patients.
The trial design is methodologically sound, comparing the combination therapy against TAGRISSO® monotherapy, which is currently the standard-of-care for EGFR-mutated NSCLC. The primary endpoint of progression-free survival (PFS) is clinically relevant, and the inclusion of investigator-assessed and independent review committee assessments adds rigor to the evaluation process. The comprehensive secondary endpoints including overall survival (OS), objective response rate, and duration of response will provide a complete efficacy profile.
The projected timeline indicates topline results by H2 2026, positioning a potential regulatory submission to China's NMPA thereafter. This targeted approach addressing specific genetic alterations (dual EGFR mutation and MET overexpression) represents the continued evolution of precision medicine in oncology. The ORPATHYS®-TAGRISSO® combination aims to address resistance mechanisms in EGFR-mutated NSCLC by simultaneously targeting MET, potentially improving outcomes in this difficult-to-treat patient population.
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 20, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the completion of patient enrollment of SANOVO, a China Phase III study of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) as a first-line treatment in certain non-small cell lung cancer (“NSCLC”) patients whose tumors harbor epidermal growth factor receptor (“EGFR”) mutation and MET overexpression. The last patient was enrolled on August 18, 2025.
This Phase III trial is a blinded, randomized, controlled study in previously untreated patients with locally advanced or metastatic NSCLC with activating EGFR mutations and MET overexpression. The study will evaluate the efficacy and safety of TAGRISSO® in combination with ORPATHYS® comparing to TAGRISSO® alone, a standard-of-care treatment option for these patients. The primary endpoint of the study is progression free survival (“PFS”) as assessed by investigators. Other endpoints include PFS assessed by an independent review committee, overall survival (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.
Topline results from the SANOVO study are estimated to be reported in the second half of 2026, followed by submission of results for presentation at an appropriate medical congress. If favorable, the results would enable a supplementary New Drug Application submission to China’s National Medical Products Administration (“NMPA”).
ORPATHYS® is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. TAGRISSO® is a third-generation, irreversible EGFR TKI.
About NSCLC and MET aberrations
Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80
MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of de novo or acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.8,9
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 and is marketed by AstraZeneca 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® is also approved in China for the treatment of patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR tyrosine kinase inhibitor therapy, in combination with TAGRISSO®.
It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.
About TAGRISSO®
TAGRISSO® (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO® (40mg and 80mg once-daily oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO® as a treatment for patients across multiple stages of EGFRm NSCLC.
There is an extensive body of evidence supporting the use of TAGRISSO® in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.
In late-stage disease, TAGRISSO® demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO® is also being investigated in this setting in combination with ORPATHYS® (savolitinib) in the SAFFRON Phase III trial and in combination with DATROWAY® (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.
TAGRISSO® also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO® is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.
About ORPATHYS® and TAGRISSO® Combination Development in EGFR-mutated NSCLC
Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15
This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this advanced setting. Positive data from the SACHI randomized Phase III trial led to the filing of a third NDA in China. Strong data from the SAVANNAH single-arm Phase II study was recently presented at the European Lung Cancer Congress (ELCC) in March 2025 and demonstrated high, clinically meaningful and durable ORR, with consistent safety results. The SAFFRON randomized Phase III trial is progressing. Following AstraZeneca’s consultation with the US Food and Drug Administration (“FDA”), we look forward to completing the SAFFRON trial as soon as possible to support potential US and other global registration filings.
SACHI: The SACHI China Phase III study evaluated the combination of ORPATHYS® and TAGRISSO® for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC after progression on EGFR TKI compared to platinum-based doublet chemotherapy. Results were presented at the ASCO Annual Meeting in June 2025. Based on the data from the SACHI study, the combination of ORPATHYS® and TAGRISSO® received approval from the China NMPA for the treatment of patients with locally advanced or metastatic EGFR mutation-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy in June 2025.
SAFFRON: In 2023, ORPATHYS® and TAGRISSO® received Fast Track Designation from the US FDA in this setting. The global SAFFRON Phase III trial is currently ongoing to assess the ORPATHYS® plus TAGRISSO® combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO®. Patients are being prospectively selected using the high MET level cut-off identified in SAVANNAH.
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of ORPATHYS®, the further clinical development for ORPATHYS®, its expectations as to whether any studies on ORPATHYS® would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of ORPATHYS®, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in other jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of ORPATHYS® for a targeted indication; and HUTCHMED and/or its partner’s ability to fund, implement and complete its further clinical development and commercialization plans for ORPATHYS®, and the timing of these events. In addition, as certain studies rely on the use of other drug products such as TAGRISSO® as combination therapeutics with ORPATHYS®, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
CONTACTS
| Investor Enquiries | +852 2121 8200 / ir@hutch-med.com |
| Media Enquiries | |
| FTI Consulting – | +44 20 3727 1030 / HUTCHMED@fticonsulting.com |
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| Brunswick – Zhou Yi | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Panmure Liberum | Nominated Advisor and Joint Broker |
| Atholl Tweedie / Emma Earl / Rupert Dearden | +44 20 7886 2500 |
| Cavendish | Joint Broker |
| Geoff Nash / Nigel Birks | +44 20 7220 0500 |
| Deutsche Numis | Joint Broker |
| Freddie Barnfield / Jeffrey Wong / Duncan Monteith | +44 20 7260 1000 |
REFERENCES
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2 American Cancer Society. What is Lung Cancer? Available at: https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed November 2022.
3 Knight SB, et al. Progress and prospects of early detection in lung cancer. Open Biol. 2017;7(9): 170070.
4 Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27.
5 Zhang Y, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48).
6 Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in 11. Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013:6;2800-12.
7 Gou LY, et al. Prevalence of driver mutations in non-small-cell lung cancers in the People’s Republic of China. Lung Cancer: Targets and Therapy. 2014; 5; 1–9.
8 Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074).
9 Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer. Journal of Hematology & Oncology. 2019;63.
FAQ
What is the SANOVO Phase III trial for HUTCHMED's ORPATHYS® studying?
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What type of drug is ORPATHYS® and what does it target?
