HUTCHMED Highlights Savolitinib SAVANNAH Phase II and Other Data at European Lung Cancer Congress 2025
HUTCHMED has presented promising results from multiple studies of savolitinib at ELCC 2025. The SAVANNAH Phase II trial showed that savolitinib plus TAGRISSO® achieved significant outcomes in MET-high lung cancer patients, with a confirmed ORR of 56% and 55% by investigator and BICR assessment respectively.
The combination therapy demonstrated median DoR of 7.1 and 9.9 months, with median PFS of 7.4 and 7.5 months. Safety profiles were consistent with established data, with Grade 3 or higher AEs occurring in 57% of patients.
Additionally, a Phase IIIb study in China revealed strong survival benefits for MET exon 14 skipping alteration NSCLC patients, with median OS of 28.3 months in treatment-naïve patients and 25.3 months in previously treated patients. The study also showed positive outcomes for patients with brain metastasis.
HUTCHMED ha presentato risultati promettenti da diversi studi su savolitinib all'ELCC 2025. Il trial di Fase II SAVANNAH ha dimostrato che savolitinib in combinazione con TAGRISSO® ha raggiunto risultati significativi nei pazienti con carcinoma polmonare MET-alto, con un ORR confermato del 56% e del 55% rispettivamente secondo la valutazione dell'investigatore e del BICR.
La terapia combinata ha mostrato una durata mediana della risposta (DoR) di 7,1 e 9,9 mesi, con una sopravvivenza libera da progressione (PFS) mediana di 7,4 e 7,5 mesi. I profili di sicurezza erano coerenti con i dati consolidati, con eventi avversi di grado 3 o superiore che si sono verificati nel 57% dei pazienti.
Inoltre, uno studio di Fase IIIb in Cina ha rivelato forti benefici in termini di sopravvivenza per i pazienti con NSCLC con alterazione di salto dell'esone 14 di MET, con una sopravvivenza mediana (OS) di 28,3 mesi nei pazienti mai trattati e 25,3 mesi nei pazienti precedentemente trattati. Lo studio ha anche mostrato risultati positivi per i pazienti con metastasi cerebrali.
HUTCHMED ha presentado resultados prometedores de múltiples estudios sobre savolitinib en el ELCC 2025. El ensayo de Fase II SAVANNAH mostró que savolitinib más TAGRISSO® logró resultados significativos en pacientes con cáncer de pulmón MET-alto, con una ORR confirmada del 56% y del 55% según la evaluación del investigador y del BICR, respectivamente.
La terapia combinada demostró una duración media de respuesta (DoR) de 7,1 y 9,9 meses, con una supervivencia libre de progresión (PFS) mediana de 7,4 y 7,5 meses. Los perfiles de seguridad fueron consistentes con los datos establecidos, con eventos adversos de grado 3 o superior ocurriendo en el 57% de los pacientes.
Además, un estudio de Fase IIIb en China reveló fuertes beneficios de supervivencia para pacientes con NSCLC con alteración de salto del exón 14 de MET, con una supervivencia media (OS) de 28,3 meses en pacientes no tratados previamente y 25,3 meses en pacientes previamente tratados. El estudio también mostró resultados positivos para pacientes con metástasis cerebral.
HUTCHMED는 ELCC 2025에서 savolitinib에 대한 여러 연구의 유망한 결과를 발표했습니다. SAVANNAH 2상 시험은 savolitinib과 TAGRISSO®의 조합이 MET가 높은 폐암 환자에서 유의미한 결과를 달성했으며, 확인된 ORR은 각각 56%와 55%로 연구자 및 BICR 평가에 따라 나타났습니다.
복합 요법은 각각 7.1개월과 9.9개월의 중앙 DoR을 보여주었으며, 중앙 PFS는 각각 7.4개월과 7.5개월이었습니다. 안전성 프로필은 기존 데이터와 일치했으며, 3등급 이상의 AE가 57%의 환자에서 발생했습니다.
또한, 중국에서 진행된 3b상 연구는 MET 엑손 14 스킵 변형 NSCLC 환자에게 강력한 생존 이점을 보여주었으며, 치료를 받지 않은 환자의 중앙 OS는 28.3개월, 이전에 치료를 받은 환자는 25.3개월로 나타났습니다. 이 연구는 뇌 전이 환자에 대한 긍정적인 결과도 보여주었습니다.
HUTCHMED a présenté des résultats prometteurs issus de plusieurs études sur le savolitinib lors de l'ELCC 2025. L'
La thérapie combinée a démontré une durée médiane de réponse (DoR) de 7,1 et 9,9 mois, avec une survie sans progression (PFS) médiane de 7,4 et 7,5 mois. Les profils de sécurité étaient conformes aux données établies, avec des événements indésirables de grade 3 ou supérieur survenant chez 57 % des patients.
De plus, une étude de Phase IIIb en Chine a révélé de forts bénéfices en termes de survie pour les patients atteints de NSCLC avec une altération de saut de l'exon 14 de MET, avec une survie médiane (OS) de 28,3 mois chez les patients n'ayant jamais été traités et de 25,3 mois chez les patients précédemment traités. L'étude a également montré des résultats positifs pour les patients ayant des métastases cérébrales.
HUTCHMED hat vielversprechende Ergebnisse aus mehreren Studien zu Savolitinib auf dem ELCC 2025 präsentiert. Die SAVANNAH Phase-II-Studie zeigte, dass Savolitinib in Kombination mit TAGRISSO® signifikante Ergebnisse bei MET-hohen Lungenkrebspatienten erzielte, mit einer bestätigten ORR von 56% und 55% gemäß der Bewertung durch den Prüfer und BICR.
Die Kombinationstherapie zeigte eine mediane Dauer der Ansprechrate (DoR) von 7,1 und 9,9 Monaten, mit einer medianen progressionsfreien Überlebenszeit (PFS) von 7,4 und 7,5 Monaten. Die Sicherheitsprofile waren konsistent mit den etablierten Daten, wobei Grad-3- oder höhere Nebenwirkungen bei 57% der Patienten auftraten.
Darüber hinaus zeigte eine Phase-IIIb-Studie in China starke Überlebensvorteile für NSCLC-Patienten mit MET Exon 14 Auslassmutation, mit einer medianen OS von 28,3 Monaten bei behandlungsnaiven Patienten und 25,3 Monaten bei zuvor behandelten Patienten. Die Studie zeigte auch positive Ergebnisse für Patienten mit Hirnmetastasen.
- High ORR of 56% in SAVANNAH Phase II trial
- Strong survival data with 28.3 months median OS in treatment-naïve patients
- Positive outcomes in brain metastasis patients
- FDA Fast Track Designation received
- Grade 3 or higher adverse events in 57% of patients
- Relatively short duration of response at 7.1-9.9 months
- PFS of 7.4-7.5 months
Insights
HUTCHMED's latest clinical data for savolitinib presents a significant step forward in addressing resistance mechanisms in lung cancer treatment. The SAVANNAH Phase II results demonstrate impressive efficacy with savolitinib plus TAGRISSO®, showing 56% objective response rate by investigator assessment in EGFR-mutated NSCLC patients with MET-driven resistance. This represents approximately double the response rates typically seen with chemotherapy in this setting.
The durability metrics are equally compelling - median duration of response of 7.1-9.9 months and progression-free survival of 7.4-7.5 months. While these timeframes might seem modest in absolute terms, they represent meaningful clinical benefit for patients who have developed resistance to first-line therapy and face treatment options.
The Phase IIIb survival data in MET exon 14 skipping NSCLC further validates savolitinib's potential, with median overall survival of 28.3 months in treatment-naïve patients - a substantial improvement for this historically difficult-to-treat molecular subtype. The 36-month survival rate of 44.7% suggests durable benefit for a significant subset of patients.
Particularly noteworthy is the benefit observed in patients with brain metastases (median OS 15.3-25.3 months), addressing a critical unmet need as these patients typically face poor outcomes with conventional therapies.
The FDA Fast Track Designation could accelerate savolitinib's regulatory pathway in the US market, potentially expanding HUTCHMED's commercial reach beyond savolitinib's current approval in China (ORPATHYS®).
The safety profile appears manageable with Grade ≥3 adverse events in 57% of patients, consistent with established profiles for both medications.
The early surufatinib data in SCLC, while promising with 57.1% survival rates at 12 and 18 months, comes from a smaller exploratory study (n=21) and will require validation in larger trials.
HUTCHMED's pipeline is showing robust clinical validation across multiple lung cancer subtypes, strengthening its position in the highly competitive precision oncology market. The savolitinib-TAGRISSO® combination addresses a specific resistance mechanism (MET overexpression/amplification) that emerges in approximately 15-20% of EGFR-mutated NSCLC patients following first-line TAGRISSO® treatment.
This represents a targeted commercial opportunity within a well-established treatment paradigm. AstraZeneca's involvement as development and commercialization partner provides significant validation and commercial infrastructure for global market penetration beyond China.
The clinical data package is maturing impressively across multiple indications. In the post-TAGRISSO® setting, the 56% response rate positions this combination competitively against chemotherapy options. For MET exon 14 skipping NSCLC, the robust survival data from the Phase IIIb study builds on savolitinib's existing approval in China while potentially supporting global regulatory submissions.
The Fast Track Designation from the FDA accelerates the development timeline and indicates regulatory recognition of the unmet need. This designation typically reduces time to market by approximately 3-6 months and provides more frequent interaction with regulators.
HUTCHMED's multi-pronged approach - targeting both acquired resistance mechanisms (savolitinib + TAGRISSO®) and specific molecular driver alterations (savolitinib monotherapy in METex14) - maximizes market potential from a single compound. The company is effectively executing a targeted oncology strategy across multiple lung cancer segments with substantial unmet needs.
The surufatinib maintenance therapy data in extensive-stage SCLC, while early, suggests potential expansion into additional difficult-to-treat lung cancer subtypes. This represents pipeline diversification beyond HUTCHMED's established focus on MET inhibition.
These clinical advances collectively strengthen HUTCHMED's position as an emerging global oncology player with both China-based commercial infrastructure and expanding global development programs.
— SAVANNAH Phase II trial demonstrated high and durable response rates with savolitinib plus TAGRISSO® in MET-high lung cancer, representing a promising chemo-free oral treatment strategy to address mechanisms of resistance in the advanced setting —
— Long-term survival benefit and safety observed in savolitinib Phase IIIb study in METex14 NSCLC —
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 20, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED, savolitinib and surufatinib, will be presented at the European Lung Cancer Congress (ELCC) 2025, taking place on March 26-29, 2025 in Paris, France.
| Title: | SAVANNAH: Savolitinib (savo) + osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and MET overexpression (OverExp) and/or amplification (Amp) following progressive disease (PD) on osi |
| Lead Author: | Myung-Ju Ahn, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea |
| Session: | Proffered Paper session 1 |
| Abstract Number: | #2O |
| Date & Time: | Wednesday, March 26, 2025,16:45 Central European Time |
| Location: | South Paris Room |
Results from the SAVANNAH Phase II trial (NCT03778229) showed savolitinib (300mg BID1) plus TAGRISSO® demonstrated a clinically meaningful and durable objective response rate (“ORR”) in patients with epidermal growth factor receptor mutated (“EGFRm”) non-small cell lung cancer (“NSCLC”) with high levels of MET overexpression and/or amplification whose disease progressed on treatment with first line TAGRISSO®.
Savolitinib plus TAGRISSO® demonstrated confirmed ORR of
Safety results and discontinuation rates due to adverse events were consistent with the established profiles of each medicine and no new safety concerns were reported. In all patients treated with savolitinib (300mg BID) plus TAGRISSO®, Grade 3 or higher adverse events (AEs) occurred in
Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”) being jointly developed and commercialized by AstraZeneca and HUTCHMED. In 2023, savolitinib and TAGRISSO® received Fast Track Designation from the US Food and Drug Administration (FDA) in this setting.
| Title: | Final Overall Survival and Long-term Safety Outcomes of Savolitinib in Patients with Locally Advanced or Metastatic NSCLC Harboring MET Exon 14 (METex14) Mutation: An Update from a Phase 3b Study |
| Lead Author: | Yongfeng Yu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China |
| Session: | Poster Display session |
| Abstract Number: | #80P |
| Date & Time: | Friday March 28, 2025,13:00 Central European Time |
| Location: | Poster area |
Updated results from the savolitinib Phase IIIb study in China demonstrated survival benefits and long-term safety in MET exon 14 skipping alteration NSCLC, particularly in treatment-naïve patients (NCT04923945). Among the 166 patients who received savolitinib treatment, the median follow-ups for 87 treatment-naïve patients and 79 previously treated patients were 34.5 and 25.1 months, respectively. In 87 treatment-naïve patients, median overall survival (“OS”) was 28.3 months (
Savolitinib is approved in China under the brand name ORPATHYS® for this patient population.
| Title: | Final overall survival (OS) of surufatinib plus PD-1/PD-L1 antibodies as maintenance therapy following first line (1L) platinum-based chemotherapy (Chemo) plus PD-1/PD-L1 antibodies in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) |
| Lead Author: | Yi Hu, Chinese PLA General Hospital, Beijing, China |
| Session: | Poster Display session |
| Abstract Number: | #310P |
| Date & Time: | Friday March 28, 2025,13:00 Central European Time |
| Location: | Poster area |
Results from the exploratory study suggests surufatinib plus immunotherapy as maintenance therapy following first line chemo-immunotherapy demonstrated durable survival benefit for patients with extensive-stage small cell lung cancer (“SCLC”) patients (NCT05509699). At data cut-off on July 31, 2024, a total of 21 patients were enrolled in this single arm Phase IIa part of the study and received at least one dose of surufatinib plus PD-1/PD-L1 antibodies treatment. The median follow-up duration was 17.1 months for maintenance and 22.5 months for first line (induction + maintenance) therapy. The 12-month and 18-month OS rates were both
About NSCLC and SAVANNAH
Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths. Lung cancer is broadly split into SCLC or NSCLC, the latter accounting for about
SAVANNAH is an ongoing randomized, global Phase II trial studying the efficacy of savolitinib added to TAGRISSO® in patients with EGFRm, locally advanced or metastatic NSCLC with MET overexpression and/or amplification who progressed following treatment with TAGRISSO®. Based on the original single-arm trial design, patients were treated with savolitinib 300 or 600mg QD3 or 300mg BID, in combination with oral TAGRISSO® 80mg QD. In 2022, a comparison of savolitinib 300 mg BID and TAGRISSO® 80 mg QD to savolitinib 300mg BID and placebo was added to the trial to evaluate contribution of components.
The trial enrolled over 360 patients in more than 80 centers globally, including in North America, Europe, South America and Asia. The primary endpoint is ORR and key secondary endpoints include PFS and DoR.
In August 2022, positive interim results from the SAVANNAH trial were presented at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (WCLC).
The global SAFFRON Phase III trial is currently ongoing to further assess the savolitinib plus TAGRISSO® combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following TAGRISSO®. Patients are being prospectively selected using the high MET level cut-off identified in SAVANNAH.
About Savolitinib
Savolitinib is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. MET is a tyrosine kinase receptor that has an essential role in normal cell development. Savolitinib 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. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is a known mechanism of acquired resistance to EGFR TKIs. The prevalence of MET depends on the sample type, detection method and assay cut-off used.
Savolitinib is approved in China and is marketed under the brand name ORPATHYS® by our partner, 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. It has been included in the National Reimbursement Drug List of China (“NRDL”) since March 2023.
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 Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFRs) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.
Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA®, and was first included in the NRDL in January 2022 for the treatment of non-pancreatic and pancreatic neuroendocrine tumors (NETs).
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, 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, and 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 U.S. 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 the savolitinib or surufatinib for the treatment of patients with lung cancer and the further clinical development of the savolitinib or surufatinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support New Drug Application approval of the savolitinib or surufatinib in lung cancer or other indications in the US, China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the safety profile of savolitinib or surufatinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for savolitinib or surufatinib and the timing of these events. In addition, as certain studies rely on the use of other drug products such as osimertinib as combination therapeutics with savolitinib and PD-1/PD-L1 antibodies as combination therapeutics with surufatinib, 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 U.S. Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. 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
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| Media Enquiries | |
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| Brunswick – Zhou Yi | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Panmure Liberum | Nominated Advisor and Joint Broker |
| Atholl Tweedie / Freddy Crossley / Rupert Dearden | +44 20 7886 2500 |
| HSBC | Joint Broker |
| Simon Alexander / Alina Vaskina / Arnav Kapoor | +44 20 7991 8888 |
| Cavendish | Joint Broker |
| Geoff Nash / Nigel Birks | +44 20 7220 0500 |
| ______________________________ | |
| References and Abbreviations | |
| 1 BID = Twice per day. | |
| 2 CI = Confidence interval. | |
| 3 QD = Once per day. |
FAQ
What were the key results of HUTCHMED's SAVANNAH Phase II trial for savolitinib plus TAGRISSO?
How effective was savolitinib in the Phase IIIb study for treatment-naïve NSCLC patients?
What safety concerns were reported for HCM's savolitinib plus TAGRISSO combination?
How did savolitinib perform in NSCLC patients with brain metastasis?
What regulatory milestone did HCM's savolitinib receive from the FDA in 2023?
