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Innovent口头介绍Dupert®(Fulzerasib)在晚期非小细胞肺癌癌症Harboring KRAS G12C突变患者中的关键2期研究的最新结果

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

PHARMA FOCUS ASIA 等信源发布 2024-09-10 14:50

可切换为仅中文


Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces an oral presentation of updated results from a pivotal Phase 2 clinical trial of Dupert®(fulzerasib)for the treatment of adult patients with advanced non-small cell lung cancer harboring the KRAS G12C mutation at the 2024 World Conference on Lung Cancer (WCLC).Fulzerasib is a novel, orally active, potent KRAS G12C inhibitor.

Innovent Biologics,Inc.是一家世界一流的生物制药公司,开发、生产和商业化用于治疗肿瘤学、心血管和代谢、自身免疫、眼科和其他主要疾病的高质量药物,该公司宣布在2024年世界肺癌会议(WCLC)上口头介绍Dupert®(fulzerasib)关键2期临床试验的最新结果,该试验用于治疗携带KRAS G12C突变的晚期非小细胞肺癌成年患者。Fulzerasib是一种新型的口服活性强效KRAS G12C抑制剂。

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.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.

根据这项单臂登记2期临床研究(NCT05005234)的结果。Dupert®(fulzerasib)于2024年8月获得NMPA批准,用于治疗患有KRAS G12C突变的成年晚期NSCLC患者,这些患者至少接受过一次全身治疗。截至数据截止日期(2023年12月13日),共有116名NSCLC受试者入选并可评估。广东省人民医院广东肺癌研究所的吴义龙教授表示:“作为一种有效的KRAS G12C抑制剂,Dupert®单药治疗已证明对KRAS G12C突变的晚期肺癌具有令人鼓舞的疗效,关键的注册研究符合预先指定的主要终点和总体有利的安全性。

As the first KRAS G12C inhibitor approved in China, Dupert® provides a new treatment option for cancer patients harboring this gene mutation in China. We look forward to seeing more KRAS G12C-mutated patients with advanced lung cancer benefit from this drug soon.'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.

作为中国批准的第一种KRAS G12C抑制剂,Dupert®为中国携带这种基因突变的癌症患者提供了新的治疗选择。我们期待着看到更多KRAS G12C突变的晚期肺癌患者很快从这种药物中受益。”Innovent高级副总裁周辉博士表示:“我们很高兴分享WCLC Dupert®注册研究的最新临床数据。

Thanks to the exceptional effic.

感谢卓越的效率。