FDA批准VENTANA PD-L1检测法作为cemiplimab治疗NSCLC的伴随诊断

肺癌前沿丨FDA批准VENTANA PD-L1检测法作为cemiplimab治疗NSCLC的伴随诊断

FDA已批准VENTANA PD-L1 (SP263)检测法扩大在晚期非小细胞肺癌(NSCLC)患者中的应用，以帮助识别可能适合接受cemiplimab-rwlc治疗的患者。[1]2021年2月，监管机构批准PD-1抑制剂cemiplimab单药治疗，用于PD-L1表达水平≥50%、无EGFR、ALK或ROS1突变、不适合手术切除或放化疗的晚期NSCLC患者的一线治疗。[2]

“VENTANA PD-L1等诊断技术助力个性化疗法帮助改善患者的预后，”罗氏诊断病理实验室的负责人Jill German在新闻发布会[1]上说：“这项批准有助于医生通过识别可能对免疫疗法cemiplimab有应答的肿瘤患者，以做出更有信心的治疗决策。”

此前cemiplimab获得批准是基于III期EMPOWER-Lung 1试验(NCT033088540)的数据。EMPOWER-Lung 1是一项多中心、开放标签、全球性III期试验，在PD-L1表达≥50%的晚期NSCLC患者中评估了在一线治疗中，cemiplimab单药治疗对比研究者选择的铂类双药化疗。[3]本试验纳入的患者年龄至少18岁，经组织学或细胞学证实为IIIB/C或IV期鳞状或非鳞状NSCLC, PD-L1表达至少为50%，ECOG体能状态评分为0~1分。从未吸烟的患者被排除在研究之外。研究以1∶1的比例将患者随机分组，两组分别接受每3周350 mg cemiplimab静脉给药或研究者选择的铂类化疗。本试验允许化疗组患者在疾病进展后跨组接受cemiplimab治疗。总生存(OS)和无进展生存(PFS)是联合主要终点。次要终点包括客观缓解率(ORR)、缓解持续时间、健康相关生活质量和安全性。

VENTANA PD-L1检测法之前曾被FDA批准作为伴随诊断，用于识别肿瘤细胞PD-L1表达≥1%的II~IIIA期NSCLC成人患者中，哪些患者在手术和铂类化疗后适合接受阿替利珠单抗辅助治疗。[4]

此前，FDA在2021年2月还批准了PD-L1 IHC 22C3 pharmDx检测法，以帮助确定可能适合接受cemiplimab治疗的患者。[5]

参考文献

1. Roche receives FDA approval of label expansion for VENTANA PD- L1 (SP263) assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo. News release. Roche. March 6, 2023. Accessed March 7, 2023. https://diagnostics.roche.com/global/en/news-listing/

2. FDA approves cemiplimab-rwlc for non-small cell lung cancer with high PD-L1 expression. News release. FDA. February 22, 2021. Accessed March 7, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/

3. Sezer A, Kilickap S, Gümüs M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274):592-604. doi:10.1016/S0140-6736(21)00228-2

4. Roche’s VENTANA PD-L1 (SP263) assay receives FDA approval as a companion diagnostic to identify certain non-small cell lung cancer patients eligible for Tecentriq (atezolizumab). News release. Roche. October 22, 2021. Accessed March 7, 2023. https://www.roche.com/media/releases/

5. Agilent PD-L1 IHC 22C3 pharmDx receives expanded FDA approval in non-small cell lung cancer (NSCLC). News release. Agilent Technologies Inc. February 22, 2021. Accessed March 7, 2023. https://www.agilent.com/about/newsroom/