Merck & Co.’s partner Kelun-Biotech said Monday the combination of its TROP2-targeting antibody-drug conjugate, given with Keytruda, has the potential to be a new first-line treatment for people with lung cancer, following the success of a late-stage study.

默克公司合作伙伴科伦生物技术公司周一表示，其靶向TROP2的抗体药物偶联物与Keytruda联合使用，有望成为肺癌患者新的一线治疗方案，此前一项晚期研究取得了成功。

According to Kelun, a trial titled OptiTROP-Lung05 found the combination of its ADC and Keytruda led to an improvement in progression-free survival compared to Keytruda alone as first-line treatment in people with non-small cell lung cancer, or NSCLC, that’s positive for a protein called PD-L1. The combination also demonstrated a “positive trend in overall survival.”.

根据科伦的说法，一项名为OptiTROP-Lung05的试验发现，对于一种名为PD-L1的蛋白呈阳性的非小细胞肺癌（NSCLC）患者，其抗体药物偶联物（ADC）与Keytruda联合使用，相比单独使用Keytruda作为一线治疗，能够改善无进展生存期。该组合还显示出“总体生存期的积极趋势”。

Kelun plans to discuss these results with Chinese regulators for a potential approval application.

科伦计划就这些结果与中国监管机构进行讨论，以申请潜在的批准。

The late-stage trial is the first pairing of an ADC and an immune checkpoint inhibitor to achieve its primary endpoint in the first-line treatment of NSCLC, Kelun said. The ADC — known as “sacituzumab tirumotecan” or “sac-TMT” — goes after a protein expressed in multiple cancers. This “TROP2” protein is also the target of Gilead Sciences’ Trodelvy and AstraZeneca and Daiichi Sankyo’s Datroway..

康方生物表示，这项晚期试验是首个将抗体偶联药物（ADC）与免疫检查点抑制剂联合使用，并在非小细胞肺癌（NSCLC）一线治疗中达到主要终点的组合。该ADC药物被称为“sacituzumab tirumotecan”或“sac-TMT”，靶向多种癌症中表达的一种蛋白。这种名为“TROP2”的蛋白也是吉利德科学公司Trodelvy和阿斯利康与第一三共合作开发的Datroway的靶点。

Kelun’s drug is already approved for two NSCLC indications as well as triple-negative breast cancer in China. Merck holds rights to the TROP2-targeting drug outside of China, including in the U.S.

科伦的药物已在中国获批用于两种非小细胞肺癌适应症以及三阴性乳腺癌。默克公司拥有该TROP2靶向药物在中国以外地区（包括美国）的权利。

Merck first

默克公司第一

partnered with Kelun in 2022

2022年与科伦合作

, gaining rights to multiple early-stage ADCs, including sac-TMT, as part of a broader effort by the pharmaceutical giant to develop new cancer drugs that could offset eroding revenue from Keytruda, which is set to lose patent protection this decade.

，获得包括sac-TMT在内的多个早期ADC的权利，这是该制药巨头为开发新的抗癌药物以弥补Keytruda因专利保护将在本十年内丧失而导致收入减少的更广泛努力的一部分。

Merck is currently testing the candidate in 15 global Phase 3 clinical trials across six tumor types, including endometrial, breast and lung cancers. Recently, Blackstone Life Sciences agreed to fuel the development of the experimental candidate with a

默克公司目前正在全球范围内对六种肿瘤类型（包括子宫内膜癌、乳腺癌和肺癌）进行15项III期临床试验测试该候选药物。最近，黑石生命科学同意为这种实验性候选药物的开发提供支持。

$700 million funding deal

7亿美元融资协议

in exchange for royalties on potential sales of sac-TMT across all approved indications.

作为交换，将获得sac-TMT在所有获批适应症上潜在销售额的特许权使用费。

While the Phase 3 study of sac-TMT was

尽管sac-TMT的第三阶段研究

conducted in China

在中国进行

, the results raised investor optimism around the drug’s future.

，该结果提升了投资者对这种药物未来的乐观情绪。

“

“

Overall, we're bullish on sac-TMT and think sac-TMT could end up being what investors originally thought Datroway could be for AstraZeneca, a $10 billion plus opportunity and be a narrative shift for Merck,” Jefferies analyst Akash Tewari wrote in a note to clients Monday.

总体而言，我们对sac-TMT持乐观态度，认为sac-TMT最终可能成为投资者最初预期Datroway对阿斯利康那样的产品，一个超过100亿美元的机会，并为默克带来叙事转变。”杰富瑞分析师阿卡什·特瓦里在周一发给客户的一份报告中写道。

Leerink Partners analyst Daina Graybosch wrote last month, following presentations at the European Society for Medical Oncology, that sac-TMT “may have the best-in-class Trop2 ADC profile, showing the most consistently robust clinical benefit across tumor types and settings.”

Leerink Partners 分析师 Daina Graybosch 在上个月欧洲医学肿瘤学会的演讲后写道，sac-TMT“可能拥有同类最佳的 Trop2 ADC 特性，在各种肿瘤类型和治疗环境中均显示出最一致且强劲的临床效益。”

Meanwhile, other TROP2-targeting ADCs are being evaluated for lung cancers. Researchers are testing Datroway

同时，其他靶向TROP2的ADC药物也正在肺癌中进行评估。研究人员正在测试Datroway。

in combination with chemotherapy and Imfinzi

与化疗和Imfinzi联合使用

as a first-line treatment for NSCLC.

作为非小细胞肺癌的一线治疗方案。

Additionally, Gilead is

此外，吉利德公司

investigating Trodelvy plus Keytruda

调查Trodelvy加Keytruda

in the first-line setting for those with PD-L1-positive NSCLC.

在PD-L1阳性的非小细胞肺癌的一线治疗中。