Pictured: Merck Research Laboratories in South San Francisco, California/iStock, hapabapa

图为：位于加利福尼亚州南旧金山的默克研究实验室/哈巴巴帕的伊斯托克

Merck on Thursday announced that its blockbuster PD-1 inhibitor Keytruda (pembrolizumab) fell short of its dual primary endpoints in the Phase III KEYLYNK-006 trial, unable to significantly improve survival outcomes in specific patients with metastatic non-squamous non-small cell lung cancer.

默克公司周四宣布，其重磅炸弹PD-1抑制剂Keytruda（pembrolizumab）在III期KEYLYNK-006试验中未达到其双重主要终点，无法显着改善特定转移性非鳞状非小细胞肺癌患者的生存结果。

KEYLYNK-006 is a randomized, open-label and two-phase study that enrolled more than 670 patients who were treated with Keytruda plus chemotherapy with pemetrexed and carboplatin or cisplatin. Participants were then randomly given maintenance therapy with either Keytruda plus AstraZeneca’s PARP inhibitor Lynparza (olaparib) or Keytruda plus chemotherapy..

KEYLYNK-006是一项随机，开放标签和两阶段研究，招募了670多名接受Keytruda加培美曲塞和卡铂或顺铂化疗的患者。然后，参与者被随机给予Keytruda加AstraZeneca的PARP抑制剂Lynparza（olaparib）或Keytruda加化疗的维持治疗。。

Without providing specific data Thursday, Merck disclosed that patients in the Keytruda-Lynparza arm did not see significantly better overall survival (OS) and progression free survival (PFS)—KEYLYNK-006’s dual primary endpoints—compared with chemotherapy controls.

在周四没有提供具体数据的情况下，默克透露，与化疗对照组相比，Keytruda Lynparza组患者的总生存期（OS）和无进展生存期（PFS）-KEYLYNK-006的双重主要终点没有显着改善。

The study focused on metastatic non-squamous non-small cell lung cancer (NSCLC) patients who did not carry EGFR, ALK or ROS1 genomic tumor aberrations. KEYLYNK-006 assessed the efficacy and safety of the Keytruda-Lynparza regimen as a first-line treatment option in these patients.

该研究集中于未携带EGFR，ALK或ROS1基因组肿瘤畸变的转移性非鳞状非小细胞肺癌（NSCLC）患者。KEYLYNK-006评估了Keytruda-Lynparza方案作为这些患者的一线治疗选择的有效性和安全性。

Gregory Lubiniecki, vice president of global clinical development at Merck Research Laboratories, in a statement said that these results “are an important reminder of how challenging it may be to treat” patients with metastatic non-squamous NSCLC.

默克研究实验室（Merck Research Laboratories）全球临床开发副总裁格雷戈里·卢比尼埃基（Gregory Lubiniecki）在一份声明中表示，这些结果“提醒人们，治疗”转移性非鳞状NSCLC患者可能具有多大挑战性。

In terms of safety, the profiles for Keytruda and Lynparza were consistent with what had been previously documented in other trials.

就安全性而言，Keytruda和Lynparza的概况与之前在其他试验中记录的一致。

A complete analysis of data from KEYLYNK-006 is ongoing, according to Merck. The company will share its findings with the scientific community in the future.

据默克公司称，对KEYLYNK-006数据的完整分析正在进行中。该公司将在未来与科学界分享其发现。

Thursday’s disappointing readout continues Keytruda’s losing streak in NSCLC. In December 2023, the pharma reported back-to-back failures for its PD-1 inhibitor in the indication.

周四令人失望的读数继续了Keytruda在非小细胞肺癌中的连胜。2023年12月，该制药公司报告其PD-1抑制剂在适应症中连续失败。

In the Phase II KeyVibe-002 trial, Merck used Keytruda combined vibostolimab—an anti-TIGIT antibody—for the treatment of metastatic NSCLC patients whose disease had progressed after immunotherapy and platinum-doublet chemotherapy. Results showed that, with or without docetaxel, the investigational regimen yielded no significant benefits on patients’ PFS and OS..

在II期KeyVibe-002试验中，默克公司使用Keytruda联合vibostolimab（一种抗TIGIT抗体）治疗免疫治疗和铂类双联化疗后疾病进展的转移性非小细胞肺癌患者。结果显示，无论是否使用多西紫杉醇，研究方案对患者的PFS和OS均无显着益处。。

Merck at the time also announced that Keytruda failed its KEYLYNK-008 trial which, as in the case of KEYLYNK-006, combined the PD-1 inhibitor with Lynparza. During a planned interim analysis, an independent data monitoring committee found that the investigational regimen did not significantly improve OS in metastatic squamous NSCLC patients, forcing the pharma to discontinue the study..

默克当时还宣布，Keytruda未能通过其KEYLYNK-008试验，该试验与KEYLYNK-006的情况一样，将PD-1抑制剂与Lynparza联合使用。在一项计划的中期分析中，一个独立的数据监测委员会发现，研究方案并没有显着改善转移性鳞状NSCLC患者的OS，迫使制药公司停止研究。。

Keytruda is a humanized monoclonal antibody that blocks the PD-1 signaling, which in turn prevents cancer cells from evading the body’s innate anti-cancer immune response. The therapy was first approved in 2014 for advanced melanoma, but has since picked up a plethora of other oncology indications and has become a fundamental cancer therapy..

Keytruda是一种人源化单克隆抗体，可阻断PD-1信号传导，从而阻止癌细胞逃避人体先天的抗癌免疫反应。该疗法于2014年首次被批准用于晚期黑色素瘤，但此后又获得了大量其他肿瘤学适应症，并已成为一种基本的癌症疗法。。

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

特里斯坦·马纳拉克（TristanManalac）是一位独立的科学作家，总部位于菲律宾马尼拉。在LinkedIn上联系他，或发电子邮件给他tristan@tristanmanalac.com或tristan.manalac@biospace.com.