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罗氏公司的TIGIT药物与NSCLC试验的不良结果有关

Roche’s TIGIT drug linked to worse outcomes in NSCLC trial

pharmaphorum 等信源发布 2024-07-04 16:17

可切换为仅中文


Roche’s anti-TIGIT drug tiragolumab has failed a lung cancer study, denting enthusiasm for the programme just as there were signs that it was getting back on track after a series of disappointing trial results.The new data comes from the phase 2/3 SKYSCRAPER-06 study, which evaluated tiragolumab in combination with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) and chemotherapy as a first-line treatment for locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).The regimen was compared to MSD’s PD-1 inhibitor Keytruda (pembrolizumab) and chemo in the trial, and showed reduced efficacy compared to the control arm, according to a Roche statement released this morning.Progression-free survival (PFS as well as overall survival was worse in the tiragolumab arm, which Roche’s chief medical officer Levi Garraway said was a “disappointing” result but would “inform our scientific understanding of the anti-TIGIT pathway and new avenues in cancer research.”Roche has another half-dozen phase 3 trials on the go with tiragolumab in other NSCLC settings, oesophageal cancer, and liver cancer.

罗氏公司的抗TIGIT药物tiragolumab未能通过一项肺癌研究,削弱了人们对该项目的热情,因为有迹象表明,在一系列令人失望的试验结果之后,该项目正在恢复正常。新数据来自2/3期摩天大楼-06研究,该研究评估了替拉鲁单抗联合罗氏PD-L1抑制剂Tecentriq(atezolizumab)和化疗作为局部晚期不可切除或转移性非鳞状非小细胞肺癌(NSCLC)的一线治疗。根据罗氏今晨发布的一份声明,该方案与MSD的PD-1抑制剂Keytruda(pembrolizumab)和chemo在试验中进行了比较,与对照组相比,疗效降低。罗氏首席医疗官Levi Garraway表示,替拉格单抗组的无进展生存期(PFS)和总生存期较差,这是一个“令人失望”的结果,但将“告知我们对抗TIGIT途径和癌症研究新途径的科学理解。”罗氏在其他NSCLC环境,食道癌和肝癌中与替拉格单抗进行了另外六项3期临床试验。

It has been hoping to start filing for approval of the drug in 2025.In 2022, Roche reported that tiragolumab missed the mark in a pair of phase 3 lung cancer studies – SKYSCRAPER-1 in NSCLC and SKYSCRAPER-2 in extensive-stage small-cell lung cancer (ES-SCLC) – raising doubts about the future of the drug.SKYSCRAPER-1 missed the PFS endpoint but patients continued to be followed to the OS readout and, last year, there was a surprise revelation that OS in the tiragolumab/Tecentriq group was trending towards an improvement over Tecentriq alone.Roche meanwhile also reported positive results in a phase 1b/2 trial in liver cancer at last year’s ASCO congress, restor.

罗氏一直希望在2025年开始申请该药物的批准。2022年,罗氏报告说,在一对3期肺癌研究中,tiragolumab没有达到目标-NSCLC中的摩天大楼-1和广泛期小细胞肺癌(ES-SCLC)中的摩天大楼-2-引起了人们对该药物未来的怀疑。摩天大楼-1错过了PFS终点,但患者继续接受OS读数,去年,令人惊讶的是,tiragolumab/Tecentriq组的OS比单独使用Tecentriq有改善的趋势。与此同时,罗氏在去年的ASCO大会restor上也报告了肝癌1b/2期试验的阳性结果。