林业发展局批准对晚期胃癌的新癌症药物Cadonilimab进行试验,目的是扩大免疫治疗,使其超出目前的PD-L1限制。 FDA approves trial of new cancer drug cadonilimab for advanced stomach cancer, aiming to expand immunotherapy access beyond current PD-L1 limits.

美国食品和药物管理局批准了Akeso的全球III期试验,COMPASSION-37/AK104-311,测试cadonilimab,一种第一类PD-1/CTLA-4双特异抗体,用于对HER2- 阴性,晚期胃或胃食道结癌的第一线治疗. The FDA has approved Akeso’s global Phase III trial, COMPASSION-37/AK104-311, testing cadonilimab—a first-in-class PD-1/CTLA-4 bispecific antibody—against nivolumab in first-line treatment for HER2-negative, advanced gastric or gastroesophageal junction cancer. 这场审判将把cadonilimab+化疗与单独化疗或与乳液相比。 The trial will compare cadonilimab plus chemotherapy to chemotherapy alone or with nivolumab. 在2024年中国根据COMPASSionion-15号试验批准cadonilimab之后,所有PD-L1级群体都获得了重大生存利益,包括低度或负度表达,而目前的PD-1级抑制剂效力较低。 This follows China’s 2024 approval of cadonilimab based on the COMPASSION-15 trial, which showed significant survival benefits across all PD-L1 groups, including low or negative expression, where current PD-1 inhibitors are less effective. 美国食品和药物管理局目前将PD-1 抑制剂限制在PD- L1 CPS ≥5 患者中,超过一半的患者无法使用,这凸显了大量未满足的需求. The FDA’s current restriction of PD-1 inhibitors to PD-L1 CPS ≥5 patients leaves over half without access, underscoring a major unmet need. 根据COMPASSION-15的数据,死亡风险总体降低了39%,PD- L1低患者降低了24%,支持cadonilimab在全球扩大免疫治疗的潜力. COMPASSION-15 data revealed a 39% reduction in death risk overall, with a 24% reduction in low PD-L1 patients, supporting cadonilimab’s potential to expand immunotherapy access globally.