Akeso announced that its internally developed PD-1/CTLA-4 bispecific antibody, cadonilimab, has received approval from the National Medical Products Administration (NMPA) for a new indication: cadonilimab in combination with fluoropyrimidine and platinum-based chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

Akeso宣布，其内部开发的PD-1/CTLA-4双特异性抗体cadonilimab已获得美国国家医疗产品管理局（NMPA）的批准，用于一种新的适应症：cadonilimab联合氟嘧啶和铂类化疗，用于局部晚期不可切除或转移性胃或胃食管交界处（G/GEJ）腺癌患者的一线治疗。

This is the second indication approval for cadonilimab in China, following its initial approval for marketing in June 2022.The approval of the new indication for cadonilimab combination therapy for first-line treatment of gastric/GEJ cancer is based on the COMPASSION-15/AK104-302 study. In the COMPASSION-15 study, the proportion of patients with PD-L1 CPS < 5 and PD-L1 CPS < 1 in the Intention-to-Treat (ITT) population reached 49.8% and 23%, respectively, which is significantly higher than the data disclosed in previous phase III studies of other immunotherapies for first-line treatment.In November 2023, the interim analysis of the study achieved the primary endpoint of overall survival (OS).

这是继2022年6月首次批准上市后，卡多尼单抗在中国的第二个适应症批准。卡多尼单抗联合治疗胃癌/GEJ癌症一线治疗的新适应症的批准是基于同情-15/AK104-302研究。在CISIC-15研究中，意向治疗（ITT）人群中PD-L1 CPS<5和PD-L1 CPS<1的患者比例分别达到49.8%和23%，明显高于之前其他一线免疫疗法III期研究中披露的数据。2023年11月，该研究的中期分析达到了总生存期（OS）的主要终点。

The results showed that the cadonilimab combination therapy significantly reduced the risk of death in advanced gastric cancer patients across all PD-L1 expression levels (including those with PD-L1 CPS ≥5 and <5), extending overall survival benefits and demonstrating notable advantages in objective response and long-term survival.

结果显示，卡多尼单抗联合治疗显着降低了所有PD-L1表达水平（包括PD-L1 CPS≥5和<5的患者）的晚期胃癌患者的死亡风险，延长了总体生存获益，并在客观反应和长期生存方面显示出显着优势。

Previous phase III trials of PD-1 inhibitors combined with chemotherapy showed limited or no clinical benefit for patients with low or negative PD-L1 expression.The results of the COMPASSION-15 study were presented as an oral report at the 2024 AACR. In the ITT population, the median overall survival (mOS) for the cadonilimab regimen reached.

先前的PD-1抑制剂联合化疗的III期临床试验显示，对于PD-L1表达低或阴性的患者，临床获益有限或没有。同情-15研究的结果在2024年AACR上以口头报告的形式呈现。在ITT人群中，卡多尼单抗方案的中位总生存期（mOS）达到。