GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announces the updated results from a registrational phase II trial of Dupert@（fulzerasib）in an oral presentation at 2024 World Conference on Lung Cancer (WCLC).Fulzerasib (GFH925/IBI351) received approval in China on Aug.

GenFleet Therapeutics是一家专注于肿瘤学和免疫学前沿治疗的临床阶段生物技术公司，在2024年世界肺癌会议（WCLC）的口头报告中宣布了Dupert@（fulzerasib）注册II期试验的最新结果。Fulzerasib（GFH925/IBI351）于8月1日在中国获得批准。

21 for the treatment of adult patients with advanced NSCLC harboring KRAS G12C mutation who have received at least one systemic therapy. The first hospital prescription was issued on Aug. 31 and the medications were already shipped to chain pharmacies across the country. This oral presentation was based on the results from a single-arm phase II clinical study (NCT05005234).

21用于治疗患有KRAS G12C突变的晚期NSCLC的成年患者，这些患者至少接受了一种全身治疗。第一张医院处方于8月31日开出，药物已被运送到全国的连锁药店。该口头介绍基于单臂II期临床研究（NCT05005234）的结果。

The study was led by Professor Yilong Wu and the latest results were presented by Professor Qing Zhou at WCLC. As of the data cutoff date (Dec 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable. Fulzerasib demonstrated encouraging antitumor activity and was generally well-tolerated with no additional safety signal observed.The confirmed objective response rate (ORR) assessed by the Independent Radiology Review Committee (IRRC) was 49.1% (95% CI: 39.7-58.6).

这项研究由吴义龙教授领导，最新结果由WCLC的周青教授介绍。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。Fulzerasib表现出令人鼓舞的抗肿瘤活性，并且通常耐受性良好，没有观察到额外的安全信号。独立放射学审查委员会（IRRC）评估的确诊客观缓解率（ORR）为49.1%（95%CI:39.7-58.6）。

Disease control rate (DCR) was 90.5% (95%CI: 83.7, 95.2). The median duration of response (DoR) was not reached. Median progression-free survival (PFS) was 9.7 months (95%CI: 5.6-11.0), and median overall survival (OS) was not yet reached.Treatment-related adverse events (TRAEs) occurred in 107 patients (92.2%) and most were Grade 1-2.

疾病控制率（DCR）为90.5%（95%CI:83.7，95.2）。未达到中位反应持续时间（DoR）。中位无进展生存期（PFS）为9.7个月（95%CI:5.6-11.0），中位总生存期（OS）尚未达到。107例患者（92.2%）发生治疗相关不良事件（TRAEs），大多数为1-2级。

The most common TRAEs were anemia, alanine aminotransferase increased, aspartate aminotransferase increased, etc.'As a potent KRAS G12C inhibitor, Dupert@ monotherapy has demonstrated encouraging efficacy in advanced lung cancer with KRAS G12C mutations, wit.

最常见的TRAE是贫血，丙氨酸氨基转移酶增加，天冬氨酸氨基转移酶增加等。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。