HUTCHMED Announces Breakthrough Therapy Designation in China for ORPATHYS® and TAGRISSO® Combination in Certain Lung Cancer Patients After Disease Progression on EGFR Inhibitor Therapy
HUTCHMED (HCM) announces that China's NMPA has granted Breakthrough Therapy Designation (BTD) to the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for treating advanced EGFR mutation-positive non-small cell lung cancer with MET amplification after disease progression on EGFR inhibitor therapy.
The treatment is being evaluated in the Phase III SACHI trial, comparing the combination therapy against standard platinum-based doublet-chemotherapy. The study's primary endpoint is progression-free survival, with additional endpoints including overall survival and objective response rate.
The BTD status may enable conditional approval and priority review for the NDA, potentially expediting the therapy's development and review process to address unmet patient needs.
HUTCHMED (HCM) annuncia che la NMPA della Cina ha conferito la Designazione di Terapia Innovativa (BTD) alla combinazione di ORPATHYS® (savolitinib) e TAGRISSO® (osimertinib) per il trattamento del cancro polmonare non a piccole cellule avanzato positivo per mutazione EGFR con amplificazione MET dopo progressione della malattia con terapia inibitrice EGFR.
Il trattamento è attualmente in fase di valutazione nello studio SACHI di Fase III, confrontando la terapia combinata con la chemioterapia standard a base di platino in doppietta. L'obiettivo primario dello studio è la sopravvivenza libera da progressione, con ulteriori obiettivi che includono la sopravvivenza complessiva e il tasso di risposta obiettiva.
Lo stato di BTD potrebbe consentire un'approvazione condizionata e una revisione prioritaria per la NDA, potenzialmente accelerando lo sviluppo e il processo di revisione della terapia per rispondere alle esigenze insoddisfatte dei pazienti.
HUTCHMED (HCM) anuncia que la NMPA de China ha otorgado la Designación de Terapia Innovadora (BTD) a la combinación de ORPATHYS® (savolitinib) y TAGRISSO® (osimertinib) para el tratamiento del cáncer de pulmón no microcítico avanzado positivo para mutación EGFR con amplificación MET después de la progresión de la enfermedad tras la terapia con inhibidores de EGFR.
El tratamiento se está evaluando en el ensayo SACHI de Fase III, que compara la terapia combinada con la quimioterapia estándar doble basada en platino. El objetivo primario del estudio es la supervivencia libre de progresión, con objetivos adicionales que incluyen la supervivencia general y la tasa de respuesta objetiva.
El estatus de BTD puede permitir una aprobación condicional y una revisión prioritaria para la NDA, lo que podría acelerar el desarrollo y el proceso de revisión de la terapia para abordar las necesidades insatisfechas de los pacientes.
HUTCHMED (HCM)는 중국 NMPA가 ORPATHYS® (savolitinib)와 TAGRISSO® (osimertinib)의 조합에 대해 혁신 치료 지정(BTD)을 승인했다고 발표했습니다. 이는 EGFR 억제제 치료 후 질병 진행이 있는 MET 증폭 EGFR 변이 양성 진행성 비소세포 폐암 치료를 위한 것입니다.
이 치료는 플래티넘 기반 이중 화학요법과 비교하는 III상 SACHI 시험에서 평가되고 있습니다. 연구의 주요 목표는 무진행 생존 기간이며, 추가 목표는 전체 생존 기간 및 객관적 반응률입니다.
BTD 상태는 NDA에 대한 조건부 승인 및 우선 검토를 가능하게 하여, 치료 개발 및 검토 과정을 가속화하고 환자의 unmet needs를 해결하는 데 도움을 줄 수 있습니다.
HUTCHMED (HCM) annonce que la NMPA de Chine a accordé la Designation de Thérapie Innovante (BTD) à la combinaison d'ORPATHYS® (savolitinib) et de TAGRISSO® (osimertinib) pour le traitement du cancer du poumon non à petites cellules avancé, positif pour la mutation EGFR et avec amplification MET, après progression de la maladie sous thérapie par inhibiteur d'EGFR.
Le traitement est évalué dans l'essai SACHI de Phase III, qui compare la thérapie combinée à la chimiothérapie standard à base de platine en double. Le critère principal de l'étude est la survie sans progression, avec des critères supplémentaires incluant la survie globale et le taux de réponse objective.
Le statut de BTD peut permettre une approbation conditionnelle et un examen prioritaire pour la NDA, ce qui pourrait accélérer le développement et le processus d'examen de la thérapie afin de répondre aux besoins non satisfaits des patients.
HUTCHMED (HCM) gibt bekannt, dass die NMPA in China die Bezeichnung als Durchbruchtherapie (BTD) für die Kombination aus ORPATHYS® (savolitinib) und TAGRISSO® (osimertinib) zur Behandlung von fortgeschrittenem nicht-kleinzelligem Lungenkrebs mit EGFR-Mutation und MET-Amplifikation nach Krankheitsprogression unter EGFR-Inhibitor-Therapie erteilt hat.
Die Behandlung wird in der Phase-III-Studie SACHI evaluiert, die die Kombinationstherapie mit der Standard-Platin-basierten Doppelhochchemotherapie vergleicht. Der primäre Endpunkt der Studie ist das progressionsfreie Überleben, während zusätzliche Endpunkte das Gesamtüberleben und die objektive Ansprechrate umfassen.
Der BTD-Status könnte eine bedingte Genehmigung und eine vorrangige Überprüfung für die NDA ermöglichen, was den Entwicklungs- und Prüfprozess der Therapie beschleunigen könnte, um den unerfüllten Bedürfnissen der Patienten Rechnung zu tragen.
- Received Breakthrough Therapy Designation in China for ORPATHYS® and TAGRISSO® combination
- BTD status enables potential fast-track approval and priority review
- Phase III SACHI trial ongoing with multiple efficacy endpoints
- None.
Insights
The Breakthrough Therapy Designation for ORPATHYS® and TAGRISSO® combination represents a significant advancement in treating EGFR-mutated NSCLC patients with MET amplification. This development is particularly noteworthy as it addresses a critical unmet need in patients who have progressed after initial EGFR inhibitor therapy.
The ongoing Phase III SACHI trial's design, comparing the combination therapy against standard platinum-based chemotherapy, could potentially establish a new treatment paradigm. The multiple efficacy endpoints including PFS, OS and ORR will provide comprehensive data on the combination's effectiveness. The BTD status could accelerate the regulatory pathway, potentially leading to faster market access.
This regulatory milestone could significantly impact HUTCHMED's market position in China's oncology space. The BTD status not only validates the combination therapy's potential but also provides a competitive advantage through expedited review and potential conditional approval. With a market cap of
The collaboration with AstraZeneca (TAGRISSO® manufacturer) strengthens HUTCHMED's position, potentially leading to increased market penetration. The NSCLC market in China represents a substantial opportunity, particularly for targeted therapies addressing specific mutations.
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation‑positive non‑small cell lung cancer (“NSCLC”) with MET amplification after disease progression on EGFR inhibitor therapy. ORPATHYS® is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”). TAGRISSO® is a third-generation, irreversible EGFR TKI.
This treatment combination is being evaluated in China in the ongoing multi-center, open-label, randomized, controlled, Phase III SACHI trial. The study is investigating the efficacy and safety of a combination of ORPATHYS® and TAGRISSO® compared to platinum-based doublet-chemotherapy (pemetrexed plus cisplatin or carboplatin), the standard‑of‑care treatment option, in patients with locally advanced or metastatic NSCLC with MET amplification after failure of EGFR inhibitor therapy. 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 (NCT05015608).
NMPA grants BTD to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies. Drug candidates with BTD may be considered for conditional approval and priority review when submitting an NDA. This indicates that the development and review of the therapy for this disease indication may be expedited, to address patients’ unmet needs more quickly.
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.7 MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of acquired resistance to EGFR TKI for metastatic EGFR-mutated NSCLC.7,8 Approximately 2
About ORPATHYS® and TAGRISSO® Combination Development in EGFR mutation-positive NSCLC
The combination of ORPATHYS® and TAGRISSO® has been studied extensively in patients with EGFR mutation-positive NSCLC, including the TATTON (NCT02143466) and SAVANNAH (NCT03778229) studies. The encouraging results from these studies led to the initiation of three Phase III trials with this combination: SACHI (NCT05015608) and SANOVO (NCT05009836) were initiated in China in 2021, and the global, pivotal Phase III SAFFRON (NCT05261399) study started enrollment in 2022. In comparison to other treatment options, this combination treatment is chemotherapy-free, biomarker-specific and orally administered, aiming for a balanced efficacy, safety and quality-of-life profile for lung cancer patients.
SAVANNAH is a global Phase II study in patients who have progressed following osimertinib due to MET amplification or overexpression, and recruitment completed earlier in 2024. The evaluation of savolitinib in combination with osimertinib was designated as a Fast Track development program by the US Food and Drug Administration (FDA) in 2023.
SAFFRON is a multi-center, randomized, controlled, open-label, global Phase III trial in patients with EGFR mutation-positive NSCLC with MET overexpression and/or amplification after disease progression on osimertinib.
SACHI is a multi-center, randomized, controlled, open-label, China Phase III trial in patients with EGFR mutation-positive NSCLC with MET amplification after disease progression on any EGFR inhibitor therapy, including third-generation EGFR-TKIs such as osimertinib.
SANOVO is a multi-center, randomized, controlled, blinded, China Phase III trial in treatment-naïve patients with EGFR mutation-positive NSCLC with MET-positive tumors.
About ORPATHYS® Approval in China
ORPATHYS® was granted conditional approval in China for the treatment of patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. ORPATHYS® is the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023. A supplementary NDA is under review which, if approved, could expand this indication to include treatment-naïve adult patients in China. More than a third of the world’s lung cancer patients are in China and, among those with NSCLC globally, approximately 2
About ORPATHYS® (savolitinib)
ORPATHYS® 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 marketed in China and 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.
In 2011, AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialize ORPATHYS®. Joint development of ORPATHYS® in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of ORPATHYS® in China. AstraZeneca is responsible for the commercialization of ORPATHYS® in China and worldwide. Sales of ORPATHYS® are recognized by AstraZeneca.
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 nearly 800,000 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® as standard of care in EGFRm NSCLC. TAGRISSO® improved patient outcomes in early-stage disease in the ADAURA Phase III trial, locally advanced disease in the LAURA Phase III trial, late-stage disease in the FLAURA Phase III trial, and with chemotherapy in the FLAURA2 Phase III trial.
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. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer 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 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 savolitinib, the further clinical development for savolitinib, its expectations as to whether any studies on savolitinib 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 savolitinib, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of savolitinib for a targeted indication; and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as osimertinib as combination therapeutics with savolitinib, 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 | |
| Ben Atwell / Alex Shaw, | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / |
| FTI Consulting | HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor | |
| Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Liberum | +44 (20) 7886 2500 |
| REFERENCES | |
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FAQ
What is the significance of HCM's Breakthrough Therapy Designation for ORPATHYS® and TAGRISSO®?
What patient population will HCM's ORPATHYS® and TAGRISSO® combination treat?
What are the primary endpoints of HCM's Phase III SACHI trial?
How does HCM's combination therapy compare to current standard treatment?
