Innovent Delivers Oral Presentation of Updated Results from a Pivotal Phase 2 Study of Dupert® (Fulzerasib) in Patients with Advanced Non-Small Cell Lung Cancer Harboring KRAS G12C Mutation
Innovent Biologics (HKEX: 01801) presented updated results from a pivotal Phase 2 study of Dupert® (fulzerasib) in advanced non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation at the 2024 World Conference on Lung Cancer. The study, involving 116 evaluable subjects, showed promising outcomes:
- Confirmed objective response rate (ORR): 49.1%
- Disease control rate (DCR): 90.5%
- Median progression-free survival (PFS): 9.7 months
Dupert® received NMPA approval in August 2024 for treating advanced NSCLC with KRAS G12C mutation after at least one systemic therapy. The drug demonstrated a favorable safety profile, with mostly Grade 1-2 treatment-related adverse events.
Innovent Biologics (HKEX: 01801) ha presentato risultati aggiornati da uno studio di fase 2 fondamentale su Dupert® (fulzerasib) in pazienti con carcinoma polmonare non a piccole cellule (NSCLC) avanzato con mutazione KRAS G12C alla Conferenza Mondiale sul Cancro ai Polmoni del 2024. Lo studio, che ha coinvolto 116 soggetti valutabili, ha mostrato risultati promettenti:
- tasso di risposta obiettiva confermata (ORR): 49,1%
- tasso di controllo della malattia (DCR): 90,5%
- Mediana di sopravvivenza libera da progressione (PFS): 9,7 mesi
Dupert® ha ricevuto approvazione NMPA nell'agosto 2024 per il trattamento di NSCLC avanzato con mutazione KRAS G12C dopo almeno una terapia sistemica. Il farmaco ha mostrato un profilo di sicurezza favorevole, con per lo più eventi avversi correlati al trattamento di Grado 1-2.
Innovent Biologics (HKEX: 01801) presentó resultados actualizados de un estudio pivotal de Fase 2 sobre Dupert® (fulzerasib) en pacientes con cáncer de pulmón no microcítico (NSCLC) avanzado con mutación KRAS G12C en la Conferencia Mundial sobre el Cáncer de Pulmón 2024. El estudio, que involucró a 116 sujetos evaluables, mostró resultados prometedores:
- tasa de respuesta objetiva confirmada (ORR): 49,1%
- tasa de control de la enfermedad (DCR): 90,5%
- Mediana de supervivencia libre de progresión (PFS): 9,7 meses
Dupert® recibió aprobación de la NMPA en agosto de 2024 para tratar NSCLC avanzado con mutación KRAS G12C después de al menos una terapia sistémica. El fármaco mostró un perfil de seguridad favorable, con en su mayoría eventos adversos relacionados con el tratamiento de Grado 1-2.
Innovent Biologics (HKEX: 01801)은 2024년 세계 폐암 회의에서 Dupert® (fulzerasib)의 KRAS G12C 변이가 있는 진행성 비소세포 폐암(NSCLC) 환자에 대한 2상 주요 연구의 업데이트된 결과를 발표했습니다. 116명의 평가 가능한 참가자를 포함한 이 연구는 유망한 결과를 보여주었습니다:
- 확인된 객관적 반응률(ORR): 49.1%
- 질병 조절률(DCR): 90.5%
- 중앙 무진행 생존 기간(PFS): 9.7개월
Dupert®는 2024년 8월 NMPA 승인을 받아 적어도 하나의 전신 요법 후 KRAS G12C 변이가 있는 진행성 NSCLC 치료에 사용됩니다. 이 약물은 대체로 1-2등급의 치료 관련 부작용을 보이면서, 우수한 안전성 프로필을 나타냈습니다.
Innovent Biologics (HKEX: 01801) a présenté des résultats actualisés d'une étude pivot de Phase 2 sur Dupert® (fulzerasib) chez des patients atteints de cancer du poumon non à petites cellules (NSCLC) avancé avec mutation KRAS G12C lors de la Conférence Mondiale sur le Cancer du Poumon en 2024. L'étude, impliquant 116 sujets évaluables, a montré des résultats prometteurs :
- taux de réponse objective confirmé (ORR) : 49,1%
- taux de contrôle de la maladie (DCR) : 90,5%
- Médiane de survie sans progression (PFS) : 9,7 mois
Dupert® a reçu l'approbation de la NMPA en août 2024 pour le traitement du NSCLC avancé avec mutation KRAS G12C après au moins une thérapie systémique. Le médicament a montré un profil de sécurité favorable, avec principalement des événements indésirables liés au traitement de Grade 1-2.
Innovent Biologics (HKEX: 01801) präsentierte aktualisierte Ergebnisse einer entscheidenden Phase-2-Studie zu Dupert® (fulzerasib) bei fortgeschrittenem nicht-kleinzelligem Lungenkrebs (NSCLC) bei Patienten mit KRAS G12C-Mutation auf der Weltkonferenz über Lungenkrebs 2024. Die Studie, an der 116 auswertbare Probanden teilnahmen, zeigte vielversprechende Ergebnisse:
- Bestätigte objektive Ansprechrate (ORR): 49,1%
- Krankheitskontrollrate (DCR): 90,5%
- Median progressionsfreies Überleben (PFS): 9,7 Monate
Dupert® erhielt im August 2024 NMPA-Zulassung zur Behandlung von fortgeschrittenem NSCLC mit KRAS G12C-Mutation nach mindestens einer systemischen Therapie. Das Medikament zeigte ein günstiges Sicherheitsprofil mit größtenteils behandlungsbezogenen Nebenwirkungen der Grade 1-2.
- Dupert® (fulzerasib) received NMPA approval in August 2024 for advanced NSCLC with KRAS G12C mutation
- High objective response rate (ORR) of 49.1% in the pivotal Phase 2 study
- Impressive disease control rate (DCR) of 90.5%
- Median progression-free survival (PFS) of 9.7 months
- Generally well-tolerated safety profile with mostly Grade 1-2 adverse events
- Median duration of response (DoR) and overall survival (OS) have not yet been reached, indicating potential need for longer-term data
Fulzerasib is a novel, orally active, potent KRAS G12C inhibitor. Based on the results from this single-arm registrational Phase 2 clinical study (NCT05005234).
Dupert® (fulzerasib) received approval by the NMPA in August 2024 for the treatment of adult patients with advanced NSCLC harboring the KRAS G12C mutation who have received at least one systemic therapy.
As of the data cutoff date (Dec 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable.
- Fulzerasib showed encouraging antitumor activity. The confirmed objective response rate (ORR) assessed by the Independent Radiology Review Committee (IRRC) was
49.1% (95% CI: 39.7-58.6). The disease control rate (DCR) was90.5% (95% CI: 83.7, 95.2). The median duration of response (DoR) has not yet been reached, while the median progression-free survival (PFS) was 9.7 months (95% CI: 5.6-11.0). Median overall survival (OS) has not been reached. - Fulzerasib was generally well-tolerated, with no additional safety signals observed. Treatment-related adverse events (TRAEs) occurred in
92.2% of patients (107 individuals), mostly Grade 1-2. The most common TRAEs included anemia, increased alanine aminotransferase, increased aspartate aminotransferase, asthenia and proteinuria.
Professor Yi-Long Wu from Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, stated: "As a potent KRAS G12C inhibitor, Dupert® monotherapy has demonstrated encouraging efficacy in advanced lung cancer with KRAS G12C mutations, with the pivotal registry study meeting the prespecified primary endpoints and overall favorable safety profile. As the first KRAS G12C inhibitor approved in
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to share the latest clinical data from the registration study of Dupert® at the WCLC. Thanks to the exceptional efficacy and good tolerability demonstrated in this study, Dupert® was recently approved as the first KRAS G12C inhibitor in
About Dupert® (Fulzerasib, KRAS G12C Inhibitor)
The RAS protein family is categorized into KRAS, HRAS and NRAS categories. KRAS mutation are detected in nearly
Fulzerasib is a novel, orally active and potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange—an essential step in pathway activation—by covalently and irreversibly modifying the cysteine residue of KRAS G12C protein. Preclinical cysteine selectivity studies demonstrated high selectivity of fulzerasib towards G12C, leading to inhibition of downstream signaling, resulting in tumor cells apoptosis and cell cycle arrest.
In September 2021, Innovent and GenFleet Therapeutics entered an exclusive license agreement for the development and commercialization of fulzerasib (Innovent R&D code: IBI351, GenFleet R&D code: GFH925) in
In January 2023, the Center for Drug Evaluation (CDE) of
As of August 2024, the CDE of NMPA has approved fulzerasib for the treatment of adult patients with advanced NSCLC harboring the KRAS G12C mutation who have received at least one systemic therapy.
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 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 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.
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.
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FAQ
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