Pictured: Roche's building in France/iStock, HJBC

图片：罗氏在法国的建筑/伊斯托克，HJBC

Roche on Thursday announced that it will stop the Phase II/III SKYSCRAPER-06 study following disappointing data from its investigational anti-TIGIT antibody tiragolumab, which was unable to significantly improve survival in patients with non-small cell lung cancer.

罗氏公司周四宣布将停止II/III期摩天大楼-06研究，此前其研究性抗TIGIT抗体tiragolumab的数据令人失望，该抗体无法显着提高非小细胞肺癌患者的生存率。

The pivotal study, which enrolled 524 patients with non-squamous non-small cell lung cancer (NSCLC), tested an investigational regimen combining tiragolumab with Roche’s PD-L1 blocker Tecentriq (atezolizumab) in the first-line setting. For the control, the pharma used a combination of Merck’s Keytruda (pembrolizumab) and chemotherapy..

这项关键性研究招募了524名非鳞状非小细胞肺癌（NSCLC）患者，在一线环境中测试了一种将替拉鲁单抗与罗氏PD-L1阻断剂Tecentriq（atezolizumab）联合使用的研究方案。为了控制，该制药公司使用了默克公司的Keytruda（pembrolizumab）和化疗的组合。。

At the time of the primary analysis, the tiragolumab regimen showed “reduced efficacy” in progression-free survival (PFS) with a hazard ratio of 1.27 in favor of the Keytruda arm. Overall survival (OS) data, which were not mature at the time of the analysis, also leaned in favor of Merck’s blockbuster with a hazard ratio of 1.33..

在初步分析时，tiragolumab方案显示无进展生存期（PFS）的“疗效降低”，风险比为1.27，有利于Keytruda组。在分析时还不成熟的总体生存（OS）数据也倾向于支持默克的百视达，风险比为1.33。。

In terms of safety, SKYSCRAPER-06 found no new signals of concern with adverse events consistent with what had previously been established for tiragolumab and Tecentriq.

在安全方面，摩天大楼06没有发现与之前为替拉格鲁单抗和Tecentriq建立的不良事件相关的新信号。

Roche CMO Levi Garraway in a statement said that the company found the results “disappointing,” adding that “it was our hope that this combination might yield improved outcomes” in metastatic non-squamous NSCLC. The pharma will coordinate the study’s termination with its investigators and will present full findings and analyses from the study at an upcoming medical congress..

罗氏CMO Levi Garraway在一份声明中表示，该公司发现结果“令人失望”，并补充称“我们希望这种组合可能会改善转移性非鳞状NSCLC的预后”。该制药公司将与其研究人员协调研究的终止，并将在即将举行的医学大会上介绍该研究的全部发现和分析。。

Tiragolumab is an investigational antibody that works by targeting TIGIT, an immune receptor found on certain immune cells, which cancer cells can exploit to weaken the body’s anti-cancer activity. Tiragolumab’s mechanism of action allows it to instead amplify the immune response and acts in a complementary manner to the popular PD-L1 blockers..

Tiragolumab是一种研究性抗体，通过靶向TIGIT发挥作用，TIGIT是一种在某些免疫细胞上发现的免疫受体，癌细胞可以利用TIGIT来削弱身体的抗癌活性。Tiragolumab的作用机制使其能够增强免疫反应，并以与流行的PD-L1阻滞剂互补的方式发挥作用。。

Roche is also studying tiragolumab in small cell lung cancer, cervical cancer, esophageal cancer, head and neck cancer and other heme and solid tumors. In January 2024, the pharma reported that tiragolumab plus Tecentriq and chemotherapy led to a significant improvement in PFS in patients with esophageal squamous cell carcinoma, compared with chemo alone..

罗氏还在研究替拉格单抗治疗小细胞肺癌、宫颈癌、食管癌、头颈癌以及其他血红素和实体瘤。2024年1月，该制药公司报告说，与单独化疗相比，替拉鲁单抗联合Tecentriq和化疗可显着改善食管鳞状细胞癌患者的PFS。。

The combination treatment also improved OS, Roche said at the time.

罗氏当时表示，联合治疗也改善了OS。

Based on the readout from SKYSCRAPER-06, Roche will assess if it needs to make any changes to its other clinical development programs.

根据摩天大楼06的读数，罗氏将评估是否需要对其其他临床开发计划进行任何更改。

In April 2024, Roche won the FDA’s approval to use Alecensa (alectinib) for the adjuvant treatment of early-stage NSCLC positive for ALK mutations. The drug is the first-ever ALK inhibitor to be approved for this indication.

2024年4月，罗氏获得FDA批准，使用Alecensa（alectinib）辅助治疗ALK突变阳性的早期NSCLC。该药物是第一种被批准用于该适应症的ALK抑制剂。

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.