Kageyama Shunichiro, Yamaguchi Shigeo, Miura Kayo, Kato Shunsuke
Dept. of Medical Oncology, Juntendo University.
Gan To Kagaku Ryoho. 2016 Jun;43(6):672-7.
Immune checkpoint inhibitors have been getting increasing attention in the field of cancer treatment, resulting in the investigation of numerous drugs and target cancers. Clinical trials of immune checkpoint inhibitors have focused on malignant melanomas and non-small cell lung cancer;however, recently, clinical trials have been carried out for other cancers. To date, 31 phase III clinical trials have been conducted for 13 types of cancer. Recently, the results of the CheckMate025 kidney cancer and CheckMate141 head and neck cancer trials have been reported. These reports showed that nivolumab significantly enhanced overall survival in comparison to that associated with an existing second-line treatment drug. Based on these results, the approval of nivolumab for use in renal cell cancer and head and neck cancer is expected in the near future. Furthermore, the results of 20 phase III clinical trials will be submitted from 2017 to 2019, expanding the approval of immune checkpoint inhibitors. However, many issues such as biomarker searches, the evaluation of antitumor effects, and the impact on medical economy remain to be resolved. In this report, we outline clinical trial trends and the future prospects for immune checkpoint inhibitors.
免疫检查点抑制剂在癌症治疗领域越来越受到关注,引发了对众多药物和目标癌症的研究。免疫检查点抑制剂的临床试验主要集中在恶性黑色素瘤和非小细胞肺癌;然而,最近也开展了针对其他癌症的临床试验。迄今为止,已针对13种癌症进行了31项III期临床试验。最近,已报道了CheckMate025肾癌试验和CheckMate141头颈癌试验的结果。这些报告表明,与现有的二线治疗药物相比,纳武单抗显著提高了总生存率。基于这些结果,预计纳武单抗在不久的将来将获批用于肾细胞癌和头颈癌。此外,2017年至2019年将提交20项III期临床试验的结果,这将扩大免疫检查点抑制剂的获批范围。然而,许多问题,如生物标志物搜索、抗肿瘤效果评估以及对医疗经济的影响等,仍有待解决。在本报告中,我们概述了免疫检查点抑制剂的临床试验趋势和未来前景。