
瑞士药企罗氏(ROPC.S)周日表示,其实验性肺癌药物 divarasib 在一项 III 期研究中,与现有疗法相比将死亡风险降低了 44%。
Swiss drugmaker Roche (ROPC.S) said on Sunday its experimental lung cancer drug divarasib reduced the risk of death by 44% compared with existing treatments in a phase III study.
罗氏称,接受 divarasib 治疗的既往治疗过的 KRAS G12C 突变非小细胞肺癌患者,中位总生存期接近 18 个月,而接受索托拉西布或阿达格拉西布治疗的患者为 12 个月。
• Roche said patients with previously treated KRAS G12C-mutated non-small cell lung cancer who received divarasib had median overall survival of nearly 18 months, compared with 12 months for those treated with sotorasib or adagrasib
Divarasib 还将疾病进展或死亡的风险降低了 42%,中位无进展生存期为 9.8 个月,对照组为 5.7 个月。
• Divarasib also lowered the risk of disease progression or death by 42%, with median progression-free survival of 9.8 months against 5.7 months in the control group
III 期 Krascendo 1 试验入组 338 名患者,将 divarasib 与两款已获批的 KRAS G12C 抑制剂进行对比。
• The Phase III Krascendo 1 trial involved 338 patients and compared divarasib with the two approved KRAS G12C inhibitors
客观缓解率方面,divarasib 组为 58%,索托拉西布或阿达格拉西布组为 32%。
• The objective response rate was 58% for divarasib, versus 32% for sotorasib or adagrasib
未观察到新的安全性发现。接受 divarasib 治疗的患者中,因治疗相关不良事件停药的比例为 4.8%,对照组为 11.7%。罗氏表示,正与卫生监管部门合作,推动该疗法惠及患者。
• No new safety findings were observed. Some 4.8% of patients on divarasib stopped treatment because of treatment-related adverse events, versus 11.7% in the control group • Roche said it was working with health authorities to bring the treatment to patients
研究结果在欧洲肿瘤内科学会大会上发布,并刊登于《新英格兰医学杂志》。
• The results were presented at the European Society for Medical Oncology Congress and published in the New England Journal of Medicine