武田药品工业（4502.T）计划明年在日本申请其胃癌药物的监管批准，此前该药物在一项晚期研究中延长了总生存期并延缓了疾病进展，公司一位高管周六在马德里举行的欧洲肿瘤内科学会（ESMO）会议上接受路透社采访时表示。
Pharmaceutical (4502.T) plans to seek regulatory approval in Japan next year for its gastric cancer drug, after it extended overall survival and delayed disease progression in a late-stage study, a company executive told Reuters.
该药物名为阿考他妥单抗塔伐替康（arcotatug tavatecan），代号TAK-921，在既往接受过至少两线治疗的晚期胃癌或胃食管结合部癌患者中达到了试验的这两个主要终点。
The drug, arcotatug tavatecan, or TAK-921, met both those main goals of the trial in patients with advanced gastric or gastroesophageal junction cancer who had received at least two prior therapies.
武田药品肿瘤研发负责人PK Morrow在采访中说：“我们将利用这些数据，明年在日本提交新药申请（NDA）。”
"We will leverage this data and file in Japan with an NDA next year," PK Morrow, who leads oncology development for the Japanese drugmaker, said in an interview on Saturday at the European Society for Medical Oncology meeting in Madrid, referring to a new drug application.
一些分析师表示，这些数据是武田药品为其肿瘤领域雄心制定的更聚焦战略的“扎实开端”。该公司正优先开发肺癌和胸部癌症、血液癌症以及胃癌药物。
Some analysts said the data was "a solid start" for Takeda's more focused strategy for its oncology ambitions. The company is prioritizing development in lung and chest cancers, blood cancers and gastric cancer.
根据独立评审，接受该药物治疗患者的中位总生存期为10.2个月，而接受医生选择的化疗患者为6.9个月，这一差异被认定具有统计学意义。
Median overall survival was 10.2 months for patients on the drug versus 6.9 months for those given doctor's choice of chemotherapy, a difference that was deemed statistically significant.
中位无进展生存期（即病情恶化所需时间）方面，武田药品药物组为7.1个月，对照组为3.1个月。
Median progression-free survival, or the time it took for the disease to worsen, was 7.1 months for the Takeda drug versus 3.1 months in the control group, according to an independent review.
Morrow表示，研究中大多数患者将武田药品的药物作为第三线治疗，30%的患者将其作为第四线或第五线治疗。
For a majority of patients in the study, Takeda's drug was their third line of therapy, and for 30% of the patients it was a fourth or fifth treatment, Morrow said.
她说：“尽管患者病情如此严重，他们仍能耐受该疗法。其次，我们依然能够展示出显著获益。”
"Despite the fact that patients were so sick, they were able to tolerate the therapy. And secondly, we were still able to show significant benefit," she said.
药物组约47%的患者出现严重副作用，化疗组约为56%。最常见的副作用是红细胞计数低，即贫血，药物组约20%的患者受影响，化疗组约为13%。
About 47% of patients on the drug had serious side effects, compared with about 56% of those on chemotherapy. The most common was low red blood cell count, or anemia, which affected about 20% of patients on the drug versus about 13% on chemotherapy.
这项涉及来自日本和中国的464名患者的研究数据于周五在ESMO会议上公布。
The data from the study of 464 patients from Japan and China was presented on Friday at the ESMO meeting.
武田药物的严重恶心、呕吐和腹泻发生率也较低，但公司表示，一名服用该药的患者因不明原因突然死亡，且死亡与治疗相关。
Severe nausea, vomiting and diarrhea were also less frequent with the Takeda drug, but one patient on the drug died suddenly from an unknown cause that was linked to the treatment, the company said.
武田的这款药物靶向某些癌细胞表面的一种名为克劳丁18.2的蛋白质，该蛋白质被用作生物标志物，以筛选最可能获益的患者。该药物属于一类被称为抗体药物偶联物的疗法，能将杀癌药物依沙替康直接递送至肿瘤细胞。
Takeda's drug targets a protein found on the surface of certain cancer cells called claudin 18.2, which was used as a biomarker for selecting patients most likely to benefit. The medicine belongs to a class of therapy known as antibody-drug conjugates. It delivers the cancer-killing agent exatecan directly to tumor cells.
武田的试验入组了至少75%的肿瘤细胞表达该靶蛋白的患者，但莫罗表示，鉴于该药物的耐受性特征，该药也可能会在靶蛋白表达水平较低的患者中进行测试。
Takeda's trial enrolled patients with at least 75% of tumor cells expressing the target protein, but Morrow said the drug could be tested in patients with lower levels, given its tolerability profile.
阿斯利康（AZN.L）的一款针对同一靶点的竞争药物在一项全球研究中达到了总生存期目标，但在无进展生存期方面未显示出获益。
A rival drug from AstraZeneca (AZN.L), which targets the same protein, met the overall survival goal in a global study but did not show benefit on progression-free survival.
武田从合作伙伴信达生物（1801.HK）处获得该药物的授权许可，信达生物拥有该药物在中国的权利。
Takeda licensed its drug from partner Innovent (1801.HK), which holds rights to the medication in China.