Innovent and ASK Pharm Jointly Announce NMPA Approval of Limertinib, a Third-generation EGFR TKI for the Treatment of Lung Cancer
Innovent Biologics and ASK Pharm announce NMPA approval of limertinib, their third-generation EGFR TKI drug for treating adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). This marks Innovent's 14th commercial product.
A Phase 2b pivotal study with 301 patients showed impressive results: 68.8% overall response rate, 92.4% disease control rate, and 11.0 months median progression-free survival. For patients with CNS lesions, the response rate was 65.9% with 10.6 months median PFS.
Additionally, limertinib met its primary endpoint in a Phase 3 trial comparing it to gefitinib for first-line NSCLC treatment. A separate NDA for first-line treatment in patients with specific EGFR mutations is under NMPA review.
Innovent Biologics e ASK Pharm annunciano l'approvazione della NMPA per limertinib, il loro farmaco TKI di terza generazione per il trattamento di pazienti adulti con cancro del polmone non a piccole cellule (NSCLC) localmente avanzato o metastatico con mutazione EGFR T790M. Questo segna il 14° prodotto commerciale di Innovent.
Uno studio pivotal di fase 2b su 301 pazienti ha mostrato risultati notevoli: un tasso di risposta globale del 68,8%, un tasso di controllo della malattia del 92,4% e una sopravvivenza libera da progressione mediana di 11,0 mesi. Per i pazienti con lesioni CNS, il tasso di risposta era del 65,9% con una sopravvivenza mediana di PFS di 10,6 mesi.
Inoltre, limertinib ha raggiunto il suo obiettivo primario in uno studio di fase 3 che lo ha confrontato con gefitinib per il trattamento di prima linea del NSCLC. Una NDA separata per il trattamento di prima linea in pazienti con specifiche mutazioni EGFR è sotto revisione da parte della NMPA.
Innovent Biologics y ASK Pharm anuncian la aprobación de la NMPA para limertinib, su medicamento TKI de tercera generación para tratar a pacientes adultos con cáncer de pulmón no microcítico (NSCLC) localmente avanzado o metastásico con mutación EGFR T790M. Esto marca el 14º producto comercial de Innovent.
Un estudio pivotal de fase 2b con 301 pacientes mostró resultados impresionantes: una tasa de respuesta global del 68,8%, una tasa de control de la enfermedad del 92,4% y una mediana de supervivencia libre de progresión de 11,0 meses. Para los pacientes con lesiones en el CNS, la tasa de respuesta fue del 65,9% con una supervivencia mediana de PFS de 10,6 meses.
Además, limertinib cumplió con su objetivo primario en un ensayo de fase 3 que lo comparó con gefitinib para el tratamiento de primera línea de NSCLC. Una NDA separada para el tratamiento de primera línea en pacientes con mutaciones específicas de EGFR está bajo revisión de la NMPA.
Innovent Biologics와 ASK Pharm은 limertinib에 대한 NMPA 승인을 발표했습니다. 이는 EGFR T790M 변이가 있는 국소 진행성 또는 전이성 비소세포 폐암(NSCLC) 성인 환자를 치료하기 위한 3세대 EGFR TKI 약물입니다. 이는 Innovent의 14번째 상업 제품입니다.
301명의 환자를 대상으로 한 2b 단계의 주요 연구는 인상적인 결과를 보여주었습니다: 68.8%의 전체 반응률, 92.4%의 질병 조절률, 그리고 11.0개월의 중간 무진행 생존 기간이었습니다. CNS 병변을 가진 환자들에 대해서는 반응률이 65.9%였으며, 중간 PFS는 10.6개월입니다.
또한, limertinib는 NSCLC 치료를 위한 1차 약제로 gefitinib와 비교한 3상 시험에서 주요 목표를 충족했습니다. 특정 EGFR 변이를 가진 환자에 대한 1차 치료를 위한 별도의 NDA가 NMPA 심사를 받고 있습니다.
Innovent Biologics et ASK Pharm annoncent l'approbation par la NMPA de limertinib, leur médicament TKI de troisième génération pour traiter les patients adultes atteints d'un cancer du poumon non à petites cellules (NSCLC) localement avancé ou métastatique avec mutation de l'EGFR T790M. Cela marque le 14ème produit commercial d'Innovent.
Une étude pivot de phase 2b impliquant 301 patients a montré des résultats impressionnants : un taux de réponse global de 68,8 %, un taux de contrôle de la maladie de 92,4 % et une survie médiane sans progression de 11,0 mois. Pour les patients avec des lésions CNS, le taux de réponse était de 65,9 % avec une PFS médiane de 10,6 mois.
De plus, limertinib a atteint son objectif principal dans un essai de phase 3 le comparant à gefitinib pour le traitement de première ligne du NSCLC. Une NDA séparée pour le traitement de première ligne chez les patients avec des mutations spécifiques de l'EGFR est en cours de révision par la NMPA.
Innovent Biologics und ASK Pharm geben die NMPA-Zulassung für limertinib bekannt, ihr Arzneimittel der dritten Generation EGFR TKI zur Behandlung von erwachsenen Patienten mit lokal fortgeschrittenem oder metastasiertem EGFR T790M-mutiertem nicht-kleinzelligem Lungenkrebs (NSCLC). Damit ist dies Innovents 14. kommerzielles Produkt.
Eine entscheidende Phase-2b-Studie mit 301 Patienten zeigte beeindruckende Ergebnisse: eine Gesamtansprechrate von 68,8%, eine Krankheitskontrollrate von 92,4% und ein medianes progressionsfreies Überleben von 11,0 Monaten. Bei Patienten mit CNS-Läsionen betrug die Ansprechrate 65,9% mit einem medianen PFS von 10,6 Monaten.
Darüber hinaus erreichte limertinib in einer Phase-3-Studie seinen primären Endpunkt, in der es mit gefitinib für die Erstlinbehandlung von NSCLC verglichen wurde. Ein separater NDA-Antrag für die Erstlinbehandlung bei Patienten mit spezifischen EGFR-Mutationen wird derzeit von der NMPA geprüft.
- Achieved NMPA approval for limertinib in EGFR T790M-mutated NSCLC
- Strong Phase 2b results with 68.8% ORR and 92.4% DCR
- Demonstrated 11.0 months median PFS and 11.1 months median DoR
- Successful Phase 3 trial results against gefitinib
- Potential market expansion with pending first-line treatment approval
- None.
A Phase 2b pivotal study evaluating 301 patients with locally advanced or metastatic EGFR T790M-mutated NSCLC demonstrated limertinib's robust efficacy and safety profile. Independent review committee（IRC） assessment showed an overall response rate (ORR) of
Additionally, limertinib met its primary endpoint in a Phase 3 clinical trial comparing it to gefitinib for first-line treatment of locally advanced or metastatic NSCLC harboring EGFR mutations. A separate NDA for the first-line treatment in adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations is currently under NMPA review.
"Limertinib has demonstrated significant efficacy and safety in NSCLC patients with EGFR T790M mutation and EGFR-sensitive mutations. Patients treated with limertinib showed a reduced risk of CNS progression or death. This approval brings new hope and options to patients with advanced EGFR-mutated NSCLC in
Dr. Hui Zhou, Senior Vice President of Innovent, stated："The approval of limertinib's first indication marks a significant milestone, providing new treatment options for T790 mutation-positive lung cancer patients who have progressed after previous EGFR-TKI treatments. We anticipate the first-line treatment indication will benefit even more patients in the near future. As our 14th commercial product, limertinib represents an important advancement in precision medicine for lung cancer. We look forward to working with ASK Pharm to bring limertinib to market and benefit Chinese patients with EGFR-mutated NSCLC."
Mr. Jingfei Ma, CEO and Executive Director of ASK Pharm, stated: "Beyond the approval for EGFR T790M+ NSCLC, limertinib is also under regulatory review for first-line treatment of EGFR 19DEL+ or L858R+ NSCLC in
About EGFR mutation-positive non-small-cell lung cancer (NSCLC)
Lung cancer remains one of the deadliest and most common cancers globally[i], with NSCLC accounting for about
About Limertinib
Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights, approved by the
The drug demonstrated success in a multi-center, randomized, double-blind, controlled Phase 3 clinical trial comparing its efficacy and safety of to gefitinib in first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR mutations. With the primary endpoint met, results will be presented at upcoming academic conferences or published in academic journals.
In October 2024, Innovent and ASK Pharm entered into a strategic collaboration and license agreement for limertinib in Mainland China.
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 14 products in the market. It has 3 new drug applications (NDA) 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.
About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm)
Founded in January 2003, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products. ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas.
ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 11 disclosed key projects focused on innovative chemical and biologic drugs. Among these, the innovative anti-tumor drug Limertinib are in the NDA stage, while ASKC109 (maltol iron capsules) and ASKB589 (Claudin18.2 monoclonal antibody) are in Phase III clinical trials. ASK Pharm has Ranked among the top 20 best industrial enterprises in
For more information, visit www.ask-pharm.com.
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.
Reference
[i] Bray F, et al. Global cancer statistics 2022. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PMID: 38572751. |
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SOURCE Innovent Biologics
FAQ
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