
根据周日公布的后期试验数据,阿斯利康(AZN.L)的实验性药物sone-ve帮助接受过至少两种前期治疗的晚期胃癌患者延长了生存期,超出了分析师的预期。
AstraZeneca's (AZN.L) experimental drug sone-ve helped patients with advanced stomach cancer who had received at least two prior treatments to live longer than analysts had expected, according to late-stage trial data presented on Sunday.
使用这种将抗体与化疗有效载荷连接起来的偶联药物的患者,中位生存期为10个月,而医生选择的化疗方案的中位生存期为5个月,死亡风险降低了53%。
Patients on the conjugate drug that links an antibody to a chemotherapy payload lived a median of 10 months, compared with 5 months on their doctor's choice of chemotherapy, a 53% reduction in the risk of death.
分析师此前预计,总生存期危险比(即死亡风险)约为0.7或更低,生存期至少增加2个月。
Analysts were expecting an overall survival hazard ratio, or risk of death, of about 0.7 or lower, with a gain of at least 2 months.
阿斯利康肿瘤血液学研发执行副总裁苏珊·加尔布雷思表示:“在难以治疗的患者群体中,总生存期延长5个月在临床上具有非常重要的意义。”
"A 5-month improvement in overall survival is very clinically significant in a difficult to treat patient population," said Susan Galbraith, executive vice president of oncology haematology research and development at AstraZeneca.
这项涉及532名患者的研究的详细数据于周日在马德里举行的欧洲肿瘤内科学会会议上公布。此前一个月,阿斯利康刚刚同意向生物制药公司Summit Therapeutics投资20亿美元,并测试sone-ve与Summit的双特异性抗体ivonescimab联合用药。
The detailed data from the 532-patient study was presented at the conference of the European Society for Medical Oncology in Madrid on Sunday, a month after AstraZeneca agreed to invest $2 billion in the biopharmaceutical company Summit Therapeutics and to test sone-ve alongside Summit's bispecific antibody ivonescimab.
阿斯利康研究中的胃食管癌患者入组条件是,其至少25%的肿瘤细胞显示出许多癌细胞上存在的蛋白质克劳丁18.2。针对该靶点的获批疗法要求临界值为75%。
Patients with gastroesophageal cancer in AstraZeneca's study were enrolled if at least 25% of their tumour cells showed claudin 18.2, a protein found on many cancer cells. The approved treatment for this target requires a 75% cutoff.
加尔布雷思表示,较低的门槛可以将能够接受治疗的患者数量增加一倍。
Galbraith said the lower threshold could double the number of patients who would be able to receive treatment.
她在接受路透社采访时表示:“我认为这预示着将其推向一线更早阶段治疗的良好机遇。”另一项涉及2,000多名患者的研究已经在患者病程的更早期阶段对该药物进行了测试。
"I think that bodes well for the opportunity to move it into the earlier line setting," she told Reuters in an interview. Another study of more than 2,000 patients, is already testing the drug earlier in a patient's course of therapy.
尽管总生存期得以延长,但作为共同主要目标的无进展生存期并未达到统计学显著性,该药物组的中位数为4.2个月,化疗组为3.8个月。加尔布雷思表示,胃癌的病情进展更难测量,因为肿瘤通常以弥散的方式扩散。
Although overall survival was extended, progression-free survival, a co-main goal, did not reach statistical significance, with medians of 4.2 months on the drug and 3.8 on chemotherapy. Galbraith said progression is harder to measure in stomach cancer because tumours often spread in a diffuse way.
汇丰银行分析师表示,这一未达标结果使得该药物更难与IBI343进行比较——IBI343是武田(4502.T)和信达生物(1801.HK)正在开发的一种竞争性克劳丁18.2疗法,该疗法在一项后期研究中实现了无进展生存期的目标。
HSBC analysts said the miss makes it harder to compare the drug with IBI343, a rival claudin 18.2 therapy being developed by Takeda (4502.T) and Innovent (1801.HK), which succeeded on its progression-free survival goal in a late-stage study.
阿斯利康药物的严重副作用发生率较低,为36.4%,而化疗组为44.8%,不过与胃部相关的副作用更为频繁,分别为11.1%对6.3%。
Serious side effects were less common with AstraZeneca's drug, 36.4% versus 44.8% on chemotherapy, though stomach-related side effects were more frequent, at 11.1% versus 6.3%.