Clin Cancer Res:Tepotinib治疗MET外显子14 (METex14)跳跃NSCLC患者的疗效和安全性:VISION研究

2021-11-22 yd2015 MedSci原创

研究表明,根据年龄、既往治疗和脑转移的不同亚组分析,Tepotinib均表现出有意义的临床活性,安全性可控制,较少的中断治疗。

MET外显子14 (METex14)跳跃突变是一个致癌驱动因素。在非小细胞肺癌(NSCLC)中发生率约为3.4%,也提示患者受益于靶向MET抑制剂。Tepotinib是一种口服的高选择性MET酪氨酸激酶抑制剂(TKI),在MET驱动基因阳性的肿瘤患者中具有明确的临床活性,并且是血脑屏障穿透剂(血浆中25%的tepotinib能够进入大脑)。在单臂、开放标签、多中心的II期临床研究VISION (NCT02864992)的初次分析中,根据独立审查委员会(IRC)评估,tepotinib的客观缓解率(ORR)46.5%基于此研究成果,Tepotinib被批准用于MET外显子14 (METex14)跳跃突变NSCLC患者。

近期,Clin Cancer Res杂志上更新了该研究的结果,根据年龄、既往治疗(化疗和免疫检查点抑制剂)和脑转移(BM)预先确定的亚组的疗效和安全性。同时采用RANO-BM标准进行回顾性分析评估颅内疗效。

截至2020年7月1日,对队列A中的152例患者进行了疗效分析。在该人群中,中位治疗时间为7.0个月(范围<0.1-43.3),中位随访时间为16.4个月(范围0.3-43.3);28例(18.4%)患者在分析时仍在治疗中。中位年龄为73.1岁(范围41-94岁),52.0%为男性,52.0%有吸烟史。队列A和C的255名患者被纳入安全性分析。

在疗效分析人群中,IRC评估的ORR为44.7%(95%CI: 36.7, 53.0)。研究人员评估的ORR为53.3% (95% CI: 45.0, 61.4)。出现应答较早,68例应答患者中57例患者(83.8%)在第一次(6周)或第二次(12周)肿瘤评估时就开始出现应答。IRC评估的中位(m) DOR为11.1个月(95% CI: 8.4, 18.5),mPFS为8.9个月(95% CI: 8.2, 11.2)。而研究人员评估的mDOR为12.5 months (95% CI:9.7, 18.3)。

                       疗效评估

IRC评估的<75岁患者的ORR为48.8% (95% CI:37.7, 60.0), ≥75岁患者的ORR为39.7% (95% CI: 28.0, 52.3)。≥80岁患者的ORR为35.1% (95% CI: 20.2, 52.5), DCR为67.6%(95% CI: 50.2, 82.0), mDOR为10.1个月(95% CI: 5.6, 18.5), 和mPFS为8.6个月(95% CI: 5.4, 15.3)。

                     不同亚组分析

IRC评估的既往未经治疗患者的ORR为44.9% (95% CI: 32.9,57.4),mDOR为10.8个月(95% CI: 6.9, not estimable [ne]) 和mPFS为8.5个月(95% CI: 6.8, 11.3)。既往治疗过患者的ORR为44.6% (95% CI: 33.7, 55.9), mDOR为11.1个月(95% CI: 9.5, 18.5)和mPFS为10.9个月(95% CI: 8.2, 12.7)。

              既往不同治疗方案对治疗疗效影响

在接受铂类药物化疗的转移性患者中,mDOR为12.4个月(95% CI: 9.5, 18.5), mPFS为11.0个月(95% CI: 8.2, 13.7)。接受免疫治疗的患者中,mDOR为9.5个月(95% CI: 6.9, ne),mPFS为10.9个月(95% CI: 3.0, 12.7)。

                 既往免疫治疗对治疗疗效影响

23例基线伴有脑转移瘤患者,17例患者接受过放射治疗。全身ORR为47.8% (95% CI: 26.8, 69.4), mDOR为9.5个月(95% CI: 5.5, ne), 以及mPFS为9.5个月(95% CI:5.7, 11.2)。15例患者使用RANO-BM 标准进行分析(12例接受过放射治疗),13例达到颅内疾病控制。7例有可测量脑转移瘤病灶患者中5例患者达到颅内病灶部分缓解。

86.3%的患者报告了治疗相关的AEs (TRAEs), 24.3%的患者发生了3 - 4级TRAEs。12.2%的患者发生了严重的TRAEs。

综上,研究表明,根据年龄、既往治疗和脑转移的不同亚组分析,Tepotinib均表现出有意义的临床活性,安全性可控制,较少的中断治疗。

原始出处:

Le X, Sakai H, Felip E, et al. Tepotinib Efficacy and Safety in Patients with MET Exon 14 Skipping NSCLC: Outcomes in Patient Subgroups from the VISION Study with Relevance for Clinical Practice. Clin Cancer Res. 2021 Nov 17:clincanres.2733.2021. doi: 10.1158/1078-0432.CCR-21-2733. Epub ahead of print. PMID: 34789481.

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    2022-10-08 一闲
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    2022-06-09 jklm09
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    2021-11-22 qinfeng

    学习了

    0

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