The U.S. Food and Drug Administration (FDA) on Friday approved

美国食品和药物管理局 (FDA) 于周五批准了

Merck & Co Inc.’s

默克公司

MRK

默克公司

Keytruda (pembrolizumab) for adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score of at least 1), as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and .

Keytruda（pembrolizumab）用于治疗可切除的局部晚期头颈部鳞状细胞癌（HNSCC）成人患者，其肿瘤表达PD-L1（综合阳性评分至少为1），作为新辅助治疗的单一药物，并继续与放疗（RT）联合或不联合顺铂作为辅助治疗。

then as a single agent

然后作为单一代理

.

。

The approval introduces the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS ≥1).

该批准引入了首个用于治疗可切除的局部晚期头颈部鳞状细胞癌成年患者的围手术期抗PD-1治疗方案，这些患者的肿瘤表达PD-L1（CPS ≥1）。

The approval is based on data from the pivotal Phase 3 KEYNOTE-689 trial.

该批准基于关键的三期 KEYNOTE-689 试验的数据。

Also Read:

另请阅读：

Merck’s Cholesterol Lowering Drug Hits Primary Goal In Two Pivotal Trials

默克的降胆固醇药物在两项关键试验中达到主要目标

At the trial’s first pre-specified interim analysis, Keytruda before surgery (neoadjuvant), then continued after surgery (adjuvant) in combination with standard of care (SOC), RT with or without cisplatin, followed by Keytruda alone, reduced the risk of event-free survival (EFS) events (defined as disease recurrence, disease progression, or death) by 30% compared to adjuvant SOC..

在试验的首次预先指定的中期分析中，与辅助标准治疗（SOC）相比，术前使用Keytruda（新辅助），术后继续使用（辅助）联合标准治疗（SOC），放疗加或不加顺铂，随后单独使用Keytruda，将无事件生存期（EFS）事件（定义为疾病复发、疾病进展或死亡）的风险降低了30%。

Among the CPS ≥1 population, the median EFS was 59.7 months in the Keytruda arm versus 29.6 months in the SOC arm.

在CPS≥1的人群中，Keytruda组的中位EFS为59.7个月，而SOC组为29.6个月。

“The introduction of Keytruda as a perioperative treatment option for certain patients with resectable locally advanced head and neck squamous cell carcinoma represents a potentially significant shift in how we manage this disease,” the Keynote-689 trial’s principal investigator, Ravindra Uppaluri, said in a statement Friday..

“对于某些可切除的局部晚期头颈部鳞状细胞癌患者，将Keytruda作为围手术期治疗选择，代表了我们管理这种疾病方式的一个潜在重要转变，”Keynote-689试验的首席研究员拉文德拉·乌帕卢里周五在一份声明中表示。

Earlier in June, Merck reportedly approached Swiss biotech

早在六月，默克 reportedly 接近瑞士生物技术公司

MoonLake Immunotherapeutics

月湖免疫治疗学

MLTX

MLTX

with a

带着一个

bid exceeding $3 billion

投标超过30亿美元

.

。

The potential deal signals renewed dealmaking activity as investor pressure has mounted on Merck to secure new assets, especially as its blockbuster

潜在的交易信号着重新开始的交易活动，因为投资者对默克公司施加了压力，要求其确保新的资产，尤其是其重磅产品。

cancer drug Keytruda

癌症药物Keytruda

faces patent expiration as early as 2028.

专利最早将于2028年到期。

In May, Merck’s Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65), met its primary endpoint of progression-free survival (PFS) for platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1

今年 5 月，默克公司的 III 期 KEYNOTE-B96 试验（也称为 ENGOT-ov65）达到了其针对表达 PD-L1 的铂类耐药复发性卵巢癌患者无进展生存期（PFS）的主要终点。

and in all comers

并且在所有的角落

.

。

The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1.

该研究还达到了肿瘤表达 PD-L1 的患者的总生存期 (OS) 次要终点。

The Keytruda-based regimen demonstrated a statistically significant and clinically meaningful improvement in PFS regardless of PD-L1 status compared to placebo plus chemotherapy

基于Keytruda的治疗方案与安慰剂加化疗相比，无论PD-L1状态如何，都显示出具有统计学意义和临床意义的PFS改善。

with or without bevacizumab

有或没有贝伐单抗

.

。

Price Action:

价格行为:

MRK stock is trading higher by 0.40% to $82.15 at last check Friday.

MRK股票在上周五最后一次交易时上涨了0.40%，达到82.15美元。

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Read Next:

接下来阅读：

RFK Jr. Appointee To CDC Advisory Committee Was A Paid Expert In Merck’s Gardasil Lawsuit

小罗伯特·肯尼迪任命的CDC顾问委员会成员曾是默克公司加德西疫苗诉讼案的付费专家

Photo by tada images via Shutterstock

照片由tada images通过Shutterstock提供

MRK

默克公司

Merck & Co Inc

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