ASCO 2020:K药联合仑伐替尼的“可乐组合”在肾透明细胞癌再显威

2020-05-30 MedSci MedSci原创

在II期临床研究Keynote-146中,入组了104名转移性透明细胞肾细胞癌患者接受帕博利珠单抗(K药)联合仑伐替尼治疗,也称为可乐组合。这些患者先前已经接受过2到3种疗法,如PD-1/L1疗法、P

在II期临床研究Keynote-146中,入组了104名转移性透明细胞肾细胞癌患者接受帕博利珠单抗(K药)联合仑伐替尼治疗,也称为可乐组合。这些患者先前已经接受过2到3种疗法,如PD-1/L1疗法、PD-1/L1联合其他抗血管药,或O+Y双免疫疗法,属于PD-1/L1耐药的一类患者。
即便是面对PD-1/L1耐药的肾癌患者,可乐组合依然能达到55%的有效率,并且中位反应持续时间(DOR)达到了12个月,临床表现优异,为PD-1/L1耐药患者提供了新的解决思路。

美国FDA加速批准PD-1抑制剂Keytruda(K药)联合Lenvima(仑伐替尼)这一“可乐组合”用于治疗特定晚期子宫内膜癌患者。这些患者为系统治疗后疾病进展不适合手术或放疗的且不伴有微卫星不稳定性高(MSI-H)或错配修复缺陷(dMMR)的患者。这是“可乐组合”首次被美国FDA获批的适应症,不仅于此,奥拉利亚,加拿大这两个国家也同时批准了这一申请。

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早在2016年ESMO大会上,仑伐替尼联合帕博利珠单抗治疗实体瘤的I期临床研究摘要,首次进入公众视野并引起了专家学者的广泛关注。本研究的主要观察终点是药物的最大耐受剂量及安全性,研究共纳入13例患者,其中肾癌8例,子宫内膜癌2例,非小细胞肺癌2例,黑色素瘤1例。在13例病人中,有7例达到了部分缓解,客观缓解率达到了54%,且没有1例患者出现疾病进展,疾病控制率高达100%。

在2017年ASCO会议上,也报道了一项关于仑伐替尼联合帕博利珠单抗治疗肾透明细胞癌的研究。该研究共入组了30例肾透明细胞癌患者,采用的治疗方式与2015年ESMO会议报道的剂量类似。30例患者在24周的客观缓解率为63%,而在初治的患者中,客观缓解率达到了83%,疾病控制率更是达到了100%。基于上述研究结果,美国FDA也批准了对PD1抑制剂 (帕博利珠单抗) 联合仑伐替尼治疗晚期肾透明细胞癌这一突破性疗法的认定。2018年ASCO会议更新了上述联合治疗方式对于肾透明细胞癌病人的长期随访结果,患者的中位PFS达到了18个月,疗效显著,且24周的客观缓解率仍然是63.3%,同样是一个非常好的结果。但是,在本研究中,不良事件发生率也较高,30例病人有22例发生了不良事件,发生率达到73%,主要不良事件多数与仑伐替尼相关,主要表现在高血压、蛋白尿等。尽管不良反应发生率较高,但相对来讲,不良反应是可控的。

该批准是基于单臂II期KEYNOTE-146/Study 111的临床试验结果,该研究纳入94例非MSI-H或dMMR子宫内膜癌肿瘤患者,这些患者每天口服20mg 仑伐替尼每3周静脉注射200mg Keytruda,直到病情恶化或出现不可接受的毒性反应为止。

结果发现,总反应率(ORR)为38.3%,其中10例(10.6%)患者完全缓解CR,26例(27.7%)患者部分缓解PR。69%(n = 25)患者的反应持续时间(DOR)≥6个月。常见的不良事件(AEs)是疲劳,高血压,肌肉骨骼疼痛,腹泻,食欲减退,甲状腺功能减退,恶心和口腔炎。

在肝癌的研究中,却显示出了另外一个结果。需要值得注意的是,仑伐替尼在肝细胞癌的研究中应用剂量相对来讲比较小,采用的是12毫克和8毫克的剂量,而帕博利珠单抗剂量同前。研究结果显示,对于不可切除的肝细胞癌,客观缓解率高达42.3%。然而,本研究中仅有30例患者入组,Part2部分入组的20例患者的中位随访时间只有3.6个月,因此能够确认的客观缓解率只有26.9%,中位PFS为9.69个月,截止到2018年3月,有23例患者仍在接受治疗。对于肝细胞癌患者而言,联合治疗疗效优于现有的治疗方式。但是,在这三个研究中同样都观察到了治疗相关的不良反应,尤其是3到4级不良反应的发生率都高达60%到70%,这与之前报道的第一个研究结果是相似的。

在2019年AACR大会上,一项关于帕博利珠单抗(K药)联合仑伐替尼(乐伐替尼),治疗不可切除肝细胞癌的安全性和疗效的研究发布了更新报道,联合疗法达到了50%的有效率和93.3%的控制率,为晚期肝癌患者带了新的希望。患者每天1次口服仑伐替尼12mg(体重≥60kg)或8mg(体重<60kg);联合帕博利珠单抗静脉用药200mg,每3周1次。

美国FDA已经授予Keytruda(pembrolizumab)与Lenvima(lenvatinib)组合疗法突破性疗法认定,用于一线治疗不能局部治疗的晚期不可切除的肝细胞癌(HCC)患者。

鉴于帕博利珠单抗联合仑伐替尼的治疗模式已经在多个实体瘤中展示出卓越的疗效,这种免疫联合的治疗模式也非常符合未来免疫治疗的研究方向,其研究成果在其他实体瘤的进一步扩大和推广非常值得期待!

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    2020-12-16 quxin068
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