2014年3月3日讯 /生物谷BIOON/ --根据3月3日发表于《临床肿瘤学》（Journal of Clinical Oncology）上的研究，来自耶鲁大学、Dana-Farber癌症研究所、约翰霍普金斯大学及相关机构研究人员组成的一支顶级科研团队，统计到了令人印象深刻的长期生存数据。这些数据表明，接受百时美施贵宝（BMS）免疫疗法nivolumab治疗后，有62%的患者在1年后仍存活，43%的患者在2年后仍存活。研究人员称，这种持久效应，同时也反映在已停止接受nivolumab治疗的患者群体中。
在一项I期临床试验中，共有107例平均预期寿命仅为1年的晚期黑色素瘤患者在为期96周的时间里，每2周静脉注射一次nivolumab。统计数据表明，nivolumab有望为晚期黑色素瘤的临床治疗提供长期生存利益。研究人员称，对转移性黑色素瘤患者来说，这些数据意义重大。
同时，该团队还观察到了另外2个关键发现：a）总生存期（OS）大于疾病无进展生存期（PFS），表明nivolumab正帮助控制晚期黑色素瘤病情，即使是已经历了新的肿瘤生长的患者群体，而这普遍被视为癌症发起新的攻击的先兆；b）在治疗结束后，肿瘤倾向于保持瘤体大小或收缩。
这些发现表明，阻断PD-1可能能够重置免疫系统和肿瘤之间的平衡，维持机体对肿瘤生长的检查。
目前，竞争对手默沙东（Merck & Co）和罗氏（Roche）也在开发PD-1和PDL-1抑制剂类免疫疗法，同样旨在调动机体自身的免疫系统，来对抗癌症。
关于Nivolumab（BMS-936559）:
癌细胞可能利用“调节子（regulator）”途径，如检查点（checkpoint）途径，逃避机体免疫系统，保护肿瘤免受免疫攻击。
Nivolumab是一种实验性、全人源化IgG4、抗程序性死亡受体1（PD-1）单克隆抗体，能够抑制PD-1与程序性死亡配体1（PD-L1/B7-H1）和程序性死亡配体2（PD-L2/B7-DC）的结合。阻断PD-1与其配体的相互作用，可能使T细胞恢复抗肿瘤免疫应答。目前，百时美施贵宝正调查nivolumab用于恶性黑色素瘤、肾癌、非小细胞肺癌及其他癌症的治疗。
nivolumab开发项目研究总数超过25个：调查作为单药疗法或与其他药物联合用药，用于多个肿瘤类型的治疗，包括：非小细胞肺癌、小细胞肺癌、黑色素瘤、肾细胞癌、肝癌、血液癌症、三阴性乳腺癌、胃癌、胰腺癌。（生物谷Bioon.com）
英文原文：Bristol-Myers' immunotherapy pioneer charts 'striking' long-term responses in melanoma
Dana-Farber investigators track nivolumab patients' impressive survival rates
A top-tier scientific team that includes investigators from Dana-Farber Cancer Institute and Johns Hopkins has tallied up some impressive long-term survival stats on a group of melanoma patients taking Bristol-Myers Squibb's ($BMY) nivolumab. According to the new research, which was published online Monday at the Journal of Clinical Oncology, 62% of the patients taking the immunotherapy were alive after one year and 43% were still alive after two years on the drug. And they say that the durable response was also reflected in patients who had stopped taking the drug.
Altogether 107 advanced melanoma patients, who shared an average life expectancy of one year, were given the drug intravenously every two weeks over a period of up to 96 weeks in the Phase I trial.
"These are striking results for patients with metastatic melanoma," said the study's senior author, Stephen Hodi, the director of the Melanoma Treatment Center at Dana-Farber. "This study provides the first demonstration of the long-term benefits this treatment approach can produce."
Two key observations caused some added excitement, says Hodi. Overall survival times for patients were longer than periods of progression-free survival, indicating that the drug was helping manage the disease even for patients who experienced new tumor growths--which is generally seen as a herald of a new assault by the cancer. In addition, tumors tended to remain the same size or shrink after the end of therapy.
"This suggests that blockade PD-1 may reset the equilibrium between the immune system and the tumor, keeping tumor growth in check," remarked Hodi.
Nivolumab is in a hectic race against rival therapies from Merck (MK-3475) and Roche ($RHHBY) which are designed to blockade PD-1 or the complementary PD-L1, helping unleash a T cell attack on cancer. And behind the leaders, practically every other major pharma company is assembling some sort of follow-up attempt to do the pioneers one better. Bristol-Myers, though, has been slow to advance into late-stage studies, preferring to linger awhile in Phase II while Merck ($MRK) has been barreling ahead as fast as it can.
Merck--in bad need of a major new drug approval--says it plans to finish a rolling submission to the FDA in the first half of this year.
关键词：百时美施贵宝,免疫疗法,nivolumab,黑色素瘤,PD-1抑制剂
信息来源:生物谷
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