百时美pd 1 Opdivo针对肺磷癌II期大获成功，股价飙升

百时美Opdivo肺癌II期大获成功，股价飙升

近日，百时美公布了Opdivo一项肺癌II期单组开放标签研究（CheckMate-063）的积极数据，该研究涉及117例既往接受过至少2种系统性治疗（有65%患者接受过3种或更多先前治疗）但病情恶化的晚期鳞状细胞非小细胞肺癌（NSCLC）患者。截至目前，随访时间最少11个月，由独立审查委员会（IRC）采用RECIST1.1标准估计的客观缓解率（ORR）为15%（95% CI = 8.7, 22.2），中位缓解持续时间尚未获得；估计的一年生存率为41%（95% CI = 31.6, 49.7），中位总生存期（mOS）为8.2个月（95% CI = 6.05, 10.91）。该研究的详细数据将提交至10月31日举行的2014芝加哥胸部肿瘤跨学科研讨会（2014 Chicago Multidisciplinary Symposium on Thoracic Oncology）。

该项研究的强劲数据远超历史水平，令业界欢呼不已。从历史数据来看，三线鳞状细胞非小细胞肺癌（NSCLC）患者客观缓解率（ORR）仅有个位数，一年存活率仅为5.5%-18%，而该项研究中ORR却达到了15%，一年存活率甚至高达41%。此外，百时美预计，中位总生存期（mOS）8.2个月可能是该群体历史数据的2倍。目前该患者群体在临床上尚无有效的治疗方案。

数据公布后，百时美股价飙升逾8%。根据百时美网站，该公司从今年4月开始向FDA滚动提交Opdivo用于鳞状细胞NSCLC的三线治疗，预计将于今年年底完成申请提交。

PD-1/PD-L1免疫疗法是当前备受瞩目的新一类抗癌免疫疗法，旨在利用人体自身的免疫系统抵御癌症，通过阻断PD-1/PD-L1信号通路使癌细胞死亡，具有治疗多种类型肿瘤的潜力,有望实质性改善患者总生存期（OS）。而各大制药巨头也正在火速推进各自的项目，调查单药疗法和组合疗法用于多种癌症的治疗，以彻底发掘该类药物的最大临床潜力。（生物谷Bioon.com）

不错

Bristol immunotherapy shows promise in lung cancer trial

Oct 30 (Reuters) - Treatment of advanced squamous cell non-small cell lung cancer (NSCLC) with Bristol-Myers Squibb Co's experimental immunotherapy nivolumab led to a one-year survival rate of 41 percent in a midstage clinical trial, according to data being presented at a medical meeting.

While the study called CheckMate-063 did not compare nivolumab with another drug or placebo, the historical one-year survival rate for patients like those in the trial, whose cancer had progressed after treatment with two or more prior therapies, is between 5.5 percent and 18 percent, the company said.

Nivolumab belongs to a highly promising new class of drugs called PD-1 inhibitors that block a tumor's ability to camouflage itself, allowing the body's immune system to recognize and attack the cancer. Merck & Co last month received the first U.S. approval of a drug from the class to treat advanced melanoma - the deadliest form of skin cancer.

"The Phase II findings from CheckMate-063 are encouraging as there are no effective treatment options for patients with refractory squamous cell lung cancer after their disease has progressed through two prior therapies," Dr Suresh Ramalingam, director of Medical Oncology at Winship Cancer Institute of Emory University, said in a statement.

Bristol-Myers, which has proposed the brand name Opdivo for nivolumab, plans to use the data as part of its rolling submissions seeking U.S. and European approvals.

The median overall survival in the 117-patient trial was 8.2 months. The median duration of response had not yet been reached.

The objective response rate (ORR), which was the primary goal of the trial, was 15 percent as assessed by an independent review committee. That compares with historical expectations in the single digits, the company said. ORR was defined as reduction of the target lesion of at least 30 percent with no new lesions.

The results were scheduled to be reported on Friday at a thoracic oncology meeting in Chicago.

Fatigue, lung tissue inflammation and diarrhea were among the most common adverse side effects reported. The discontinuations rate due to drug-related side effects was 12 percent, and there were two drug-related deaths, the company reported.

Lung cancer is the leading cause of cancer deaths globally, with about 1.5 million each year, according to the World Health Organization. NSCLC accounts for about 85 percent of lung cancer cases. (Reporting by Bill Berkrot in New York; editing by Matthew Lewis)

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这个不知道非正版出来了吗？鳞癌的选择实在是太少了

还以为能和黑色素瘤一样，持续应答，文章没披露多少百分比能持续应答

上市了也吃不起，YL！！！
搜了一下，“前面提到的两个最重要的药物——Keytruda和Opdivo，每年费用基本上相同，为15万美元。”

不知道副作用是怎样的，希望能快点出YL

希望中国也有绿色通道尽快上市，美国每年费用为15万美元话，进口到中国好像有22%的税，再加上流通环节，岂不是要近20万美元？

这个价位真心承受不起，高价药无法通过医保，治疗仍是问题。