Nivolumab在高级HCC中产生近12％的存活率近60％

StephenW

Nivolumab Yields 12-Month Survival of Nearly 60% in Advanced HCC
News | April 21, 2017 | Liver, Gallbladder, and Biliary Tract Cancers, Gastrointestinal Cancer
By Ian Ingram

The latest results from the CheckMate 040 study showed that the programmed cell death ligand 1 (PD-L1) checkpoint inhibitor nivolumab produces durable responses with promising long-term survival rates in patients with advanced, unresectable hepatocellular carcinoma (HCC), regardless of hepatitis B and C status.

The updated interim data were presented at the International Liver Congress 2017 in Amsterdam.

The overall objective response rate by blinded independent central review was 14.5%, with responses ongoing in 15 of 21 patients (71.4%) and a 12-month overall survival rate of 59.9%. Responses to nivolumab occurred regardless of PD-L1 tumor expression.

The overall objective response rate was 19.3% by investigator assessment. Grade 3/4 adverse events related to nivolumab occurred in 16.6% of patients.

“The durable responses and survival rates that were achieved with nivolumab are very welcome, especially as the side effects were manageable,” said study author Bruno Sangro, MD, PhD, of the Clinica Universidad de Navarra in Spain, in a press release. “These data support the potential of nivolumab in the treatment and stabilization of advanced liver cancer in those patients who have progressed on sorafenib, with or without chronic viral hepatitis.”

The dose-expansion portion of the phase I/II CheckMate 040 trial included 145 advanced HCC patients who were previously treated with sorafenib; 132 of these patients (91%) had progressed on sorafenib and 12 patients (8.3%) were intolerant. All were treated with 3 mg/kg intravenous nivolumab every 2 weeks until disease progression or toxicity.

With a median follow-up of 12.9 months, the median duration of response was not yet reached. Of the 21 patients who responded to nivolumab, eight had a response that lasted longer than 12 months. The median overall survival rate was 16.7 months, and was not reached in patients with chronic hepatitis B and C infections.

“The reported median survival of 16.7 months in patients previously treated with sorafenib is promising and it encourages the evaluation of nivolumab in patients affected with HCC,” said Alejandro Forner, MD, PhD, of the Hospital Clinic Barcelona in Spain, in the press release.

StephenW

Nivolumab在高级HCC中产生近12％的存活率近60％
新闻| 2017年4月21日|肝，胆囊和胆道癌，胃肠癌
由伊恩·英格拉姆

来自CheckMate 040研究的最新研究结果显示，程序性细胞死亡配体1（PD-L1）检查点抑制剂尼莫单抗在晚期不可切除的肝细胞癌（HCC）患者中产生持久的反应，具有预期的长期存活率，无论乙型肝炎和C状态。

更新的临时数据在2017年在阿姆斯特丹举行的国际肝脏大会上提出。

独立中央复审盲目总体客观反应率为14.5％，21例患者中有15例（71.4％），12个月总体生存率为59.9％。无论PD-L1肿瘤表达如何，对尼非莫班的反应都发生。

调查员评估总体客观反应率为19.3％。 16.6％的患者发生与nivolumab相关的3/4级不良事件。

新西兰纳西瓦大学医学博士Dr. Bruno Sangro博士说：“尼莫单抗达到的持久的反应和生存率非常受欢迎，特别是副作用可以控制。 “这些数据支持nivolumab治疗和稳定晚期肝癌的潜力，这些患者在有或没有慢性病毒性肝炎的索拉非尼进展。”

I / II期CheckMate 040试验的剂量扩张部分包括先前用索拉非尼治疗的145例晚期HCC患者;这些患者中有132例（91％）在索拉菲尼进展，12例（8.3％）不耐受。所有患者均每3周接受3 mg / kg静脉注射尼非美珠治疗，直至发生疾病进展或毒性。

中位随访时间为12.9个月，中位数回复时间尚未达到。在21例对尼瓦单抗做出反应的患者中，8例患者反应持续时间超过12个月。中位总生存率为16.7个月，未见慢性乙型肝炎和丙型肝炎感染患者。

西班牙巴塞罗那医院诊所的Alejandro Forner博士说：“以前用索拉非尼治疗的患者报告的中位生存期为16.7个月是有希望的，并且鼓励对患有HCC的患者中的nivolumab进行评估。” 。