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默克药物提高难治性子宫癌患者生存率Merck Drug Boosts Survival From Hard-to-Treat Uterine Cancer

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默克公司(Merck & Co.)的一款实验性药物帮助晚期子宫内膜癌女性患者的生存期显著长于接受化疗的患者,增强了该公司对这款正在多种肿瘤中研究的新型疗法的雄心。

An experimental drug from Merck & Co. helped women with advanced endometrial cancer live significantly longer than those receiving chemotherapy, bolstering the company’s ambitions for the novel treatment it is studying in a wide range of tumors.

据在周一举行的欧洲肿瘤内科学会(European Society for Medical Oncology)大会上公布的一项晚期研究结果显示,接受沙库替单抗替鲁替康(sacituzumab tirumotecan,称为 sac-TMT)治疗的患者中位生存期为 19 个月,而接受化疗的患者为 12.1 个月。该疗法也伴随显著副作用,包括贫血和致残性口腔溃疡。

By Madison Muller Patients receiving sacituzumab tirumotecan, known as sac-TMT, lived a median of 19 months, compared with 12.1 months for those given chemotherapy, according to results from a late-stage study presented at the European Society for Medical Oncology congress on Monday. The treatment also came with significant side effects, including anemia and debilitating mouth sores.

默克此前曾表示该试验达到了其目标,但未提供细节。完整结果显示了患者获益的程度,这些患者的疾病在化疗后进展,通常会在一年内死亡。根据美国癌症协会的数据,预计 2026 年美国将有约 6.8 万名女性被诊断患有子宫癌。

Merck previously said the trial met its goals, without providing details. The full results show the extent of the benefit for patients, who typically die within a year if their disease progresses after chemotherapy. About 68,000 US women are expected to be diagnosed with uterine cancer in 2026, according to the American Cancer Society.

默克研究实验室总裁李德安在数据发布前的采访中表示:“这是少数死亡率呈上升趋势的癌症之一。我们正试图扭转这一趋势。” 这些发现可能为 sac-TMT 获得首个美国批准铺平道路,这对这款正在 17 项晚期研究中针对多种癌症类型进行测试的药物而言是一个重要里程碑。默克通过与四川科伦博泰生物制药有限公司达成协议,获得了该疗法在中国以外地区的权利,押注它能成为其肿瘤业务的重要补充,因为其重磅药物 Keytruda 面临着来自廉价仿制药的迫在眉睫的竞争。

“It is one of the only cancers with an increasing rate of mortality,” Dean Li, president of Merck Research Laboratories, said in an interview before the data were released. “What we’re trying to do is shift that.”The findings could pave the way for sac-TMT’s first US approval, an important milestone for the drug being tested in 17 late-stage studies across numerous types of cancer. Merck acquired rights to the treatment outside China through a deal with Sichuan Kelun-Biotech Biopharmaceutical Co., betting it could become a major addition to its oncology business as its blockbuster drug Keytruda faces looming competition from cheaper copies.

但更大的奖赏仍在前方。默克正在肺癌和其他常见肿瘤中推进 sac-TMT 的研究,如果试验成功,可能会打开规模大得多的商业机会。汇丰银行(HSBC)的分析师估计,sac-TMT 及其联合疗法可能带来 120 亿至 150 亿美元的机会。

But the bigger prize remains ahead. Merck is pursuing sac-TMT in lung cancer and other common tumors, where successful trials could open up substantially larger commercial opportunities. Analysts at HSBC estimate that sac-TMT and its combinations could be a $12 billion to $15 billion opportunity.

这种热情在很大程度上集中在非小细胞肺癌上。肺癌是全球最常见的肿瘤类型,而非小细胞肺癌则是迄今为止最普遍的类型。

Much of that enthusiasm has centered on non-small cell lung cancer. Lung cancer is the most common tumor type in the world, and non-small cell is by far the most prevalent type.

周末,默克分享了一项在中国进行的研究结果,结果显示,与标准治疗相比,sac-TMT 联合 Keytruda(帕博利珠单抗)将疾病进展或死亡的风险降低了 51%。该结果发表在《新英格兰医学杂志》上,超出了华尔街的预期,增强了人们对该药物潜力的信心,RBC Capital Markets(加拿大皇家银行资本市场)的分析师在一份报告中表示。

Over the weekend, Merck shared results from a study in China, where sac-TMT combined with Keytruda reduced the risk of disease progression or death by 51% compared with standard treatment. The results, published in the New England Journal of Medicine, exceeded Wall Street’s expectations and bolstered confidence in the drug’s potential, analysts from RBC Capital Markets said in a note.

“我们认为,这些数据支持该疗法成为这一高度未满足临床需求人群的标准治疗方案,”RBC 的 Trung Huynh 表示。

“We believe this data supports standard of care potential in this high unmet need population,” said RBC’s Trung Huynh.

新选择 子宫内膜癌的获益伴随着额外的毒性。接受 sac-TMT 治疗的患者中,有 54% 以上出现了严重的治疗相关副作用,而接受化疗的患者这一比例为 41%。在涉及近 800 名患者的研究中,两组各有 3 人死于治疗相关并发症。

New Options The benefits in endometrial cancer came with added toxicity. More than 54% of patients receiving sac-TMT experienced severe treatment-related side effects, compared with 41% of those receiving chemotherapy. Three people in each group died from treatment-related complications in the study involving nearly 800 patients.

尽管如此,研究结果仍为患有晚期子宫内膜癌的女性提供了一种潜在的新选择,这些患者在初始治疗后病情进展时,鲜有有效的治疗手段。

Still, the findings offer a potential new option for women with advanced endometrial cancer, who have few effective treatments once their disease progresses after initial therapy.

“我们的研究为全球患有子宫内膜癌的女性带来了急需的希望,”研究共同调查员 Michelle Lightfoot 表示,她是 NYU Grossman School of Medicine(纽约大学格罗斯曼医学院)的助理教授,也是 Perlmutter Cancer Center(珀尔马特癌症中心)的妇科肿瘤学家。在一份声明中,她的同事们称这些结果将改变临床实践,并表示治疗指南可能需要更新以纳入 sac-TMT。

“Our study offers much needed hope to women worldwide living with endometrial cancer,” said study co-investigator Michelle Lightfoot, an assistant professor at NYU Grossman School of Medicine and gynecologic oncologist at Perlmutter Cancer Center. In a statement, her colleagues called the results practice-changing and said treatment guidelines may need to be updated to incorporate sac-TMT.

去年,默克从美国食品药品监督管理局获得了一张特殊优先审评券,有望缩短该药物的审评时间。8 月,默克首席执行官 Rob Davis 表示,公司计划将该优先审评券用于子宫内膜癌适应症的申报。

Last year, Merck received a special voucher from the US Food and Drug Administration, potentially shortening the drug’s review time. In August, Merck Chief Executive Officer Rob Davis said the company plans to use the voucher for its filing in endometrial cancer.

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