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Clinical activity and safety of Pembrolizumab in Ipilimumab pre-treated patients with uveal melanoma.
OncoImmunology ( IF 7.2 ) Pub Date : 2016-07-29 , DOI: 10.1080/2162402x.2016.1143997
Ioannis Karydis 1 , Pui Ying Chan 2 , Matthew Wheater 3 , Edurne Arriola 3 , Peter W Szlosarek 4 , Christian H Ottensmeier 1
Affiliation  

BACKGROUND Untreated metastatic uveal melanoma (UM) carries a grave prognosis. Unlike cutaneous melanoma (CM), there are no established treatments known to significantly improve outcomes for a meaningful proportion of patients. Inhibition of the PD1-PDL1 axis has shown promise in the management of CM and we here report a two center experience of UM patients receiving pembrolizumab. METHODS To assess the efficacy and safety of pembrolizumab, we retrospectively analyzed outcome data of 25 consecutive UM patients participating in the MK3475 expanded access program (EAP) who received pembrolizumab at 2 mg/kg 3 weekly. Tumor assessment was evaluated using RECIST 1.1 and immune-related Response Criteria (irRC) by CT scanning. Toxicity was recorded utilizing Common Terminology Criteria for Adverse Events ("CTCAE") v4.03. RESULTS Twenty-five patients were identified receiving a median of six cycles of treatment. Two patients achieved a partial response and six patients stable disease. After a median follow-up of 225 d median progression free survival (PFS) was 91 d and overall survival (OS) was not reached. There was a significant trend for improved outcomes in patients with extrahepatic disease progression as opposed to liver only progression at the outset. Five patients experienced grade 3 or 4 adverse events (AEs); there were no treatment related deaths. CONCLUSIONS Pembrolizumab 2mg/kg q3w is a safe option in UM patients. Disease control rates, particularly in the subgroup of patients without progressive liver disease at the outset are promising; these results merit further investigation in clinical trials possibly incorporating liver targeted treatment modalities.

中文翻译:

依匹莫单抗预处理的葡萄膜黑色素瘤患者的派姆单抗的临床活性和安全性。

背景未经治疗的转移性葡萄膜黑色素瘤(UM)预后严重。与皮肤黑素瘤(CM)不同,尚无成熟的治疗方法可显着改善相当一部分患者的预后。PD1-PDL1轴的抑制在CM的治疗中显示出了希望,我们在此报告接受pembrolizumab的UM患者的两个中心经验。方法为了评估派姆单抗的疗效和安全性,我们回顾性分析了连续25例参加MK3475扩展访问计划(EAP)的每周接受2 mg / kg 3派姆单抗治疗的UM患者的结局数据。使用RECIST 1.1和免疫相关反应标准(irRC)通过CT扫描评估肿瘤评估。使用不良事件通用术语标准(“ CTCAE”)v4.03记录毒性。结果确定了25名患者接受了6个疗程的中位数治疗。2例患者获得部分缓解,6例患者病情稳定。中位随访225 d后,中位无进展生存期(PFS)为91 d,未达到总体生存期(OS)。与肝外疾病的发展相比,肝外疾病进展的患者有改善结局的明显趋势。5名患者经历了3或4级不良事件(AEs);没有与治疗有关的死亡。结论Pembrolizumab 2mg / kg q3w是UM患者的安全选择。疾病控制率,尤其是一开始就没有进行性肝病的患者亚组是有希望的;
更新日期:2019-11-01
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