Innovent and HUTCHMED Jointly Announce NMPA Conditional Approval for TYVYT® (Sintilimab Injection) in Combination with ELUNATE® (Fruquintinib) for the Treatment of Advanced Endometrial Cancer
Innovent Biologics and HUTCHMED announce that their combination therapy of TYVYT® (sintilimab injection) and ELUNATE® (fruquintinib) has received conditional approval from China's NMPA for treating advanced endometrial cancer patients with pMMR tumors who failed prior systemic therapy.
The approval is based on the FRUSICA-1 study results, which showed significant efficacy with an IRC-assessed ORR of 35.6% and DCR of 88.5%. The median PFS reached 9.5 months and OS 21.3 months, with a rapid median time to tumor response of 1.6 months. This marks TYVYT®'s eighth approved indication, following priority review status and breakthrough therapy designation.
Innovent Biologics e HUTCHMED annunciano che la loro terapia combinata di TYVYT® (iniezione di sintilimab) ed ELUNATE® (fruquintinib) ha ricevuto l'approvazione condizionata dalla NMPA cinese per il trattamento di pazienti con cancro endometriale avanzato che presentano tumori pMMR e che non hanno risposto a precedenti terapie sistemiche.
L'approvazione si basa sui risultati dello studio FRUSICA-1, che ha mostrato un'efficacia significativa con un tasso di risposta obiettivo (ORR) valutato dall'IRC del 35,6% e un tasso di controllo della malattia (DCR) dell'88,5%. La sopravvivenza libera da progressione mediana ha raggiunto i 9,5 mesi e la sopravvivenza globale è stata di 21,3 mesi, con un tempo mediano rapido per la risposta tumorale di 1,6 mesi. Questo segna l'ottava indicazione approvata per TYVYT®, dopo lo stato di revisione prioritaria e la designazione di terapia innovativa.
Innovent Biologics y HUTCHMED anuncian que su terapia combinada de TYVYT® (inyección de sintilimab) y ELUNATE® (fruquintinib) ha recibido aprobación condicional de la NMPA de China para tratar a pacientes con cáncer endometrial avanzado que tienen tumores pMMR y que no han respondido a la terapia sistémica previa.
La aprobación se basa en los resultados del estudio FRUSICA-1, que mostró una eficacia significativa con un ORR evaluado por IRC del 35,6% y un DCR del 88,5%. La mediana de PFS alcanzó los 9,5 meses y la OS fue de 21,3 meses, con un tiempo mediano rápido para la respuesta tumoral de 1,6 meses. Esto marca la octava indicación aprobada para TYVYT®, tras el estado de revisión prioritaria y la designación de terapia innovadora.
Innovent Biologics와 HUTCHMED는 TYVYT®(sintilimab 주사)와 ELUNATE®(fruquintinib)의 병용 요법이 이전의 전신 요법에 실패한 pMMR 종양을 가진 진행성 자궁내막암 환자를 치료하기 위해 중국 NMPA의 조건부 승인을 받았다고 발표했습니다.
이번 승인은 FRUSICA-1 연구 결과를 바탕으로 하였으며, IRC에서 평가한 ORR이 35.6%이고 DCR이 88.5%로 나타났습니다. 중앙 무이한 생존 기간(PFS)은 9.5개월, 전체 생존 기간(OS)은 21.3개월에 도달했으며, 종양 반응에 대한 중앙 시간은 1.6개월로 빠르게 진행되었습니다. 이는 TYVYT®가 우선 검토 및 혁신 요법으로 지명된 후 여덟 번째 승인된 적응증을 나타냅니다.
Innovent Biologics et HUTCHMED annoncent que leur thérapie combinée de TYVYT® (injection de sintilimab) et d'ELUNATE® (fruquintinib) a reçu une approbation conditionnelle de la NMPA chinoise pour traiter des patients atteints d'un cancer de l'endomètre avancé avec des tumeurs pMMR qui n'ont pas répondu à une thérapie systémique antérieure.
Cette approbation repose sur les résultats de l'étude FRUSICA-1, qui ont montré une efficacité significative avec un taux de réponse objectif (ORR) évalué par l'IRC de 35,6 % et un taux de contrôle de la maladie (DCR) de 88,5 %. La médiane de survie sans progression a atteint 9,5 mois et la survie globale 21,3 mois, avec un temps médian pour la réponse tumorale de 1,6 mois. Cela marque la huitième indication approuvée pour TYVYT®, après le statut d'examen prioritaire et la désignation de thérapie innovante.
Innovent Biologics und HUTCHMED geben bekannt, dass ihre Kombinationstherapie mit TYVYT® (Sintilimab-Injektion) und ELUNATE® (Fruquintinib) eine bedingte Zulassung von der NMPA in China für die Behandlung von Patienten mit fortgeschrittenem Endometriumkarzinom, die pMMR-Tumoren aufweisen und auf vorherige systemische Therapien nicht angesprochen haben, erhalten hat.
Die Zulassung basiert auf den Ergebnissen der FRUSICA-1-Studie, die eine signifikante Wirksamkeit mit einer vom IRC bewerteten ORR von 35,6 % und einem DCR von 88,5 % zeigte. Die mediane PFS lag bei 9,5 Monaten und die OS bei 21,3 Monaten, mit einer schnellen medianen Zeit bis zur Tumorantwort von 1,6 Monaten. Dies stellt die achte zugelassene Indikation für TYVYT® dar, nach dem Status der prioritärer Überprüfung und der Bezeichnung als Durchbruchstherapie.
- Received conditional approval from NMPA for new cancer treatment indication
- Strong clinical results with 35.6% ORR and 88.5% DCR
- Impressive survival metrics with 21.3 months median OS
- Fast response time of 1.6 months (mTTR)
- Expands market reach with eighth approved indication for TYVYT
- Approval is conditional, requiring confirmatory Phase 3 study
- to specific patient subset (pMMR tumors)
Insights
This regulatory approval represents a significant milestone in endometrial cancer treatment. The combination of TYVYT® (sintilimab) and ELUNATE® (fruquintinib) demonstrated impressive clinical results with an
The rapid onset of efficacy (1.6 months median time to response) and manageable safety profile make this combination particularly valuable for patients who have failed prior systemic therapy. The conditional approval addresses a critical unmet need in the treatment landscape for advanced endometrial cancer patients with pMMR tumors, who typically have poorer responses to single-agent immunotherapy.
This approval strengthens both companies' market positions in China's oncology sector. For Innovent, this marks TYVYT's eighth approved indication, expanding its commercial potential. The combination therapy approach could drive increased revenue through complementary drug sales. For HUTCHMED, this new indication for ELUNATE® in combination with TYVYT® opens up a new market segment in gynecologic oncology.
The priority review status and breakthrough therapy designation from NMPA highlight the treatment's potential market impact. With a planned Phase 3 confirmatory study, there's potential for full approval and possible expansion to other markets. This development could positively influence both companies' market valuations and competitive positions in the growing Chinese oncology market.
The conditional approval by the NMPA was supported by registration stage data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who have experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy. Results from FRUSICA-1 were presented at the American Society of Clinical Oncology annual meeting in June 2024.[i] The study results showed that IRC-assessed ORR and DCR was
"This approval of sintilimab plus fruquintinib could represent a paradigm shift in managing this challenging disease. This innovative combination not only leverages the synergistic effects of targeted therapy and immunotherapy, but also addresses a critical gap in treatments available for patients with limited responses to traditional therapies," said Prof. Xiaohua Wu, Director of the Department of Gynecologic Oncology at Fudan University Affiliated Cancer Hospital and Principal Investigator of the FRUSICA-1 study. "With the promising efficacy and manageable safety profile observed in clinical trials, we are eager to have this treatment option available to patients. It brings us closer to our goal of improving survival and enhancing quality of life for patients living with advanced endometrial cancer."
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "The approval of sintilimab and fruquintinib combination therapy marks a meaningful advancement in the treatment landscape for advanced endometrial cancer. Together with HUTCHMED, we aim to provide a novel treatment option that improves survival rates and quality of life for patients facing limited treatment options against this aggressive cancer. TYVYT® (sintilimab injection), as a cornerstone in immuno-therapy, continues to be evaluated in clinical trials in combination with novel modalities. We remain steadfast in our commitment to reinforcing the leadership position of TYVYT® (sintilimab injection) in immuno-therapy and driving forward treatment solutions through innovation and cooperation."
"This NMPA approval of fruquintinib in combination with sintilimab represents a significant advancement for patients with advanced endometrial cancer who have long awaited more effective treatments. It underscores the potential of fruquintinib to be used with other therapeutic agents to improve patient outcomes," said Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. "It is also a testament to our ongoing efforts to extend the clinical benefit of fruquintinib to a broader patient population. We are eager to make this innovative treatment available to advanced endometrial cancer patients as soon as we can and will continue to explore further opportunities to bring hope to more patients battling cancer."
About Endometrial Cancer
Endometrial cancer originates in the uterus and remains a significant global health challenge. In 2020, approximately 417,000 people worldwide were diagnosed with endometrial cancer, resulting in around 97,000 deaths.[ii] Іn
About Sintilimab
Sintilimab, marketed as TYVYT® (sintilimab injection) in
In
- For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy;
- For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations;
- For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy;
- For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer;
- For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment;
- For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
- For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
Furthermore, sintilimab's eighth indication, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, was approved by the NMPA in December 2024.
In addition, two clinical studies of sintilimab have met their primary endpoints:
- Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma;
- Phase 3 study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy.
About Fruquintinib
Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor ("VEGF") receptors (VEGFR-1, -2 and -3). VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy.
Fruquintinib is approved for marketing for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF therapy or anti-epidermal growth factor receptor ("EGFR") therapy (RAS wild-type) in
In December 2024, fruquintinib was approved by NMPA in combination with sintilimab for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement:
（1）Innovent does not recommend the use of any unapproved drug (s)/indication (s).
（2）Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) were developed by Eli Lilly and Company.
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. 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 it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in
Innovent's Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.
References |
[i] Wu X, et al. Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with PMMR status: Results from a multicenter, single-arm phase 2 study. J Clin Oncol 42, 2024 (suppl 16; abstr 5619). DOI: 10.1200/JCO.2024.42.16_suppl.5619. |
[ii] The Global Cancer Observatory, World Fact Sheet. Accessed June 12, 2023. |
[iii] The Global Cancer Observatory, China Fact Sheet. Accessed June 12, 2023. |
[iv] Yi A, et al. Real-world characteristics and treatment pattern of patients with newly diagnosed endometrial cancer in China. J Clin Oncol. 2023;41, no. 16_suppl (June 01, 2023) e17613-e17613. DOI: 10.1200/JCO.2023.41.16_suppl.e17613. |
[v] Koppikar S, et al. Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with endometrial cancer. ESMO Open. 2023;8(1):100774. DOI: 10.1016/j.esmoop.2022.100774. |
[vi] Siegel RL, et al. Cancer statistics, 2023. CA Cancer J Clin. 2023;73(1):17-48. DOI:10.3322/caac.21763. |
[vii] Wang J, et al. Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451. DOI: 10.1080/19420862.2019.1654303. |
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FAQ
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