与Cemiplimab PD-1封锁先进皮肤鳞状细胞癌。

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Migden先生,Rischin D, Schmults CD, Guminski, Hauschild,刘易斯KD,钟CH, Hernandez-Aya L, Lim, Chang ALS, Rabinowits G,泰国AA,邓恩,休斯BGM Khushalani倪,莫迪B, Schadendorf D,高B, F Seebach,李,李J,马赛厄斯M,布斯J, Mohan K, Stankevich E, Babiker嗯,Brana我Gil-Martin M, Homsi J,约翰逊ML,莫雷诺V,妞妞J, Owonikoko TK,帕帕多普洛斯KP, Yancopoulos GD,罗伊,我愤怒毫克

与Cemiplimab PD-1封锁先进皮肤鳞状细胞癌。

郑传经地中海J。2018年7月26日,379 (4):341 - 351。doi: 10.1056 / NEJMoa1805131。Epub 2018年6月4。

PubMed ID

29863979 (在PubMed

]

文摘

背景:目前还没有批准用于治疗系统性治疗先进皮肤鳞状细胞癌。这种癌症可能对免疫疗法,因为肿瘤的突变负担高,疾病的风险是与免疫抑制密切相关。在剂量递增cemiplimab第一阶段研究的一部分,一个深刻而持久的反应是观察病人转移性皮肤鳞状细胞癌。方法:我们报告的结果的第一阶段研究cemiplimab扩张组患者的局部晚期或转移性皮肤鳞状细胞癌,以及关键的第二阶段研究的结果对一群转移性疾病患者(转移性疾病组)。在两项研究中,患者接受静脉注射的剂量cemiplimab(3毫克/公斤体重)每2周,每8周反应进行评估。在第二阶段的研究中,主要终点是响应率,评估独立的中央审查。结果:在第一阶段的扩张组研究中,应对cemiplimab观察13个26例(50%;95%可信区间(CI), 30到70)。在第二阶段的转移性疾病组研究中,发现的一个反应是28的59例(47%;95%可信区间,34 - 61)。 The median follow-up was 7.9 months in the metastatic-disease cohort of the phase 2 study. Among the 28 patients who had a response, the duration of response exceeded 6 months in 57%, and 82% continued to have a response and to receive cemiplimab at the time of data cutoff. Adverse events that occurred in at least 15% of the patients in the metastatic-disease cohort of the phase 2 study were diarrhea, fatigue, nausea, constipation, and rash; 7% of the patients discontinued treatment because of an adverse event. CONCLUSIONS: Among patients with advanced cutaneous squamous-cell carcinoma, cemiplimab induced a response in approximately half the patients and was associated with adverse events that usually occur with immune checkpoint inhibitors. (Funded by Regeneron Pharmaceuticals and Sanofi; ClinicalTrials.gov numbers, NCT02383212 and NCT02760498 .).

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药物

Cemiplimab

药物靶点

药物	目标	类	生物	药理作用	行动
Cemiplimab	程序性细胞死亡蛋白1	蛋白质	人类	是的	抑制剂 抗体	细节