Ann Oncol:新型抗CTLA4抗体Quavonlimab联合派姆单抗一线治疗NSCLC的疗效和安全性

2021-01-19 MedSci原创 MedSci原创

Quavonlimab(MK-1308)是一种新型抗CTLA-4抗体。本研究旨在评估Quavonlimab与Pembrolizumab(票面党课)联合应用于晚期转移性实体瘤的安全性和疗效。

Quavonlimab(MK-1308)是一种新型抗CTLA-4抗体。本研究旨在评估Quavonlimab与Pembrolizumab(票面党课)联合应用于晚期转移性实体瘤的安全性和疗效。

该研究是一项I期临床试验,分为两个阶段。在剂量递增(DE)阶段:晚期/转移性实体肿瘤患者接受初始平坦剂量的Quavonlimab作为单一治疗[25 mg(队列1)、75 mg(队列2)或200 mg(队列3)],继以相同剂量的Quavonlimab+派姆单抗(Q3W)治疗,共4疗程。在剂量验证(DC)阶段:IIIB/IV期非小细胞肺癌(NSCLC)患者接受一线Quavonlimab[25 mg Q3W(A组)、25 mg Q6W(B组)、75 mg Q6W(C组)或75 mg Q3W(E组)]+派姆单抗治疗。主要目标是安全性和耐受性,以及确定与派姆单抗联合使用时的推荐2期剂量(RP2D)。客观应答率(ORR)是次要终点。基于PD-L1表达、肿瘤突变负荷(TMB)和循环CD4+/CD8+细胞变化的疗效是探索性终点。

在DE阶段招募了39位患者:队列1、2、3分别有14位、17位和8位;DC阶段招募了134位患者:A、B、C、E组分别有40位、40位。40位和14位。没有达到最大耐受剂量

DE阶段队列1、2和3的3~5级治疗相关不良事件(AE)发生率分别为0%、23.5%和75.0%,DC阶段A、B、C和E组的AE发生率分别为35.0%、30.0%、35.0%和57.1%。在NSCLC患者中观察到所有剂量水平/方案都具有一定疗效。A、B、C和E组的ORR值分别为40.0%、37.5%、27.5%和35.7%。PD-L1表达和循环CD4+细胞总数与ORR相关。

综上,在本研究所评价的所有Quavonlimab剂量/方案中,Quavonlimab 25mg Q6W联合派姆单抗显示出相似的疗效和更好的安全性,选择该方案作为RP2D

原始出处:

Perets R,Bar J,Rasco D W et al. Safety and efficacy of quavonlimab, a novel anti-CTLA-4 antibody (MK-1308), in combination with pembrolizumab in first-line advanced non-small-cell lung cancer. Ann Oncol, 2020, 10.1016/j.annonc.2020.11.020.

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    2021-12-15 snf701207
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    2021-01-19 李吉里吉里

    想得积分

    0

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    2021-01-19 健康达人

    肿瘤免疫是大家关心的话题,K药与其它药对比,值得关注!

    0

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    2021-01-19 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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    2021-01-19 anti-cancer

    谢谢梅斯分享这么多精彩信息

    0

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    2021-01-19 肿肿

    NSCLC下一步突破在于新靶点了,靶向治疗和免疫治疗基本见顶了,再有新的就需要新机制了

    0

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    2021-01-19 Jessie Zhang

    在本研究所评价的所有Quavonlimab剂量/方案中,Quavonlimab 25mg Q6W联合派姆单抗显示出相似的疗效和更好的安全性,选择该方案作为RP2D。

    0

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依曲康唑已被重新用作多种恶性肿瘤的抗癌治疗剂。在临床前模型中,伊曲康唑具有抗血管生成特性,并可抑制Hedgehog (Hh)通路活性。Gerber等进行了一个机会窗口试验,以确定伊曲康唑在患者中的生物

欧盟将审查默克的肺癌靶向药物Tepotinib

Tepotinib设计用于治疗患有间充质-上皮转化因子基因(MET)外显子14(METex14)跳跃突变的成年人的晚期非小细胞肺癌(NSCLC)。

阿斯利康的Tagrisso在美国被批准作为NSCLC的辅助疗法

FDA允许Tagrisso(osimertinib)治疗EGFR外显子19缺失或外显子21 L858R突变的非小细胞肺癌(NSCLC)患者。

Opdivo联合Yervoy:欧洲获批一线治疗转移性非小细胞肺癌

Opdivo加Yervoy结合两轮化疗,与单独化疗相比将死亡风险降低31%。

Clin Cancer Res:恩替诺特联合派姆单抗治疗ICII难治性NSCLC

抗PD-1/PD-L1免疫疗法作为单药疗法或与化疗联合应用显著改善了非小细胞肺癌(NSCLC)患者的预后,目前,纳武单抗和阿特朱单抗已获批用于转移性NSCLC,durvalumab获批用于局部晚期NS

肺癌新一代靶向药劳拉替尼:显着改善ALK阳性NSCLC患者的无进展生存期

劳拉替尼是新一代酪氨酸激酶抑制剂,专门开发用来抵抗对其他ALK抑制剂产生抗性的肿瘤,并具有较强的血脑屏障通透性。