巴维昔单抗非小细胞肺癌二期临床取得很大进展？

happens

本来在关注传说中的端粒酶抑制剂(Imetelstat)，号称可以广谱抗癌，不幸发现坏消息，二期临床显示端粒酶抑制剂对乳癌没有效果之余还是缩短了生存期，对非小细胞肺癌效果不明显，现在还不清楚Geron会否继续进行端粒酶抑制剂对非小细胞肺癌的三期临床。原文如下
[urlhttp://ir.geron.com/phoenix.zhtm ... 3274&highlight=[/url]

失望之下，去搜索了一下最近针对非小细胞肺癌的二期临床进展，发现惊喜。有一个名叫巴维昔单抗的药对非小细胞肺癌二期临床取得非常好的效果，与多西他赛联合使用，总体生存期是多西他赛单药的两倍。估计巴维昔单抗单药也是很有威力。现在厂家很有信心通过三期，接下来会和美国FDA就二期临床结果开会，并计划于2013年中开始三期临床。大家可以关注一下。原文链接如下

http://www.drugdevelopment-techn ... hase-ii-nsclc-trial
Peregrine Pharmaceuticals has announced that interim data from its Phase II trial in refractory non-small cell lung cancer (NSCLC) patients demonstrates a statistically significant improvement in overall survival for patients receiving Bavituximab plus Docetaxel, versus Docetaxel alone.
The double-blind, placebo-controlled study evaluated two dose levels of bavituximab (bavituximab-containing arms) given with docetaxel, versus docetaxel plus placebo (control arm).
Peregrine clinical and regulatory affairs vice president Joseph Shan said the study yielded positive results in the most important endpoint: overall survival.
"The positive overall response rates and progression free survival in both bavituximab-containing arms seen earlier in the study has now translated into a statistically significant extension in overall survival for patients, a result rarely achieved in phase II clinical trials." Shan said.
"The quality of this data gives us a solid foundation for designing a phase III trial with an increased probability of success. We are planning for an end-of-phase II meeting with the FDA as we plan to initiate this trial by mid-2013."
The interim data showed a statistically significant improvement in overall survival (hazard ratio 0.524, p-value .0154) and a doubling of median overall survival (OS) in the bavituximab-containing arms compared to the control arm.
The interim results from the trial, which enrolled 121 patients with second-line non-squamous NSCLC following one prior chemotherapy regimen, showed no significant safety differences between the three treatment arms as determined by the trial's independent data monitoring committee.
Baseline characteristics were well-balanced across the treatment arms while the tumour responses were determined in accordance with response evaluation criteria in solid tumours based on blinded central radiology review.
Peregrine president and chief executive officer Steven King said; "Robust data from this Phase II trial clearly demonstrate a significant benefit in overall survival with a good safety profile in patients receiving bavituximab plus docetaxel compared to those receiving docetaxel plus placebo."

happens

巴维昔单抗 bavituximab对抗乳癌和肺癌的二期临床均取得很大成功，在乳癌的例子里面，巴维西单抗和传统化疗药物多西他赛联用居然可以取得总共60%以上的有效率和总共11%的完全响应（也就是治疗后用显影手段已经看不到有肿瘤），这是令人十分振奋的效果。事实上，多西他赛作为一种传统的化疗药物，会减弱人体的免疫系统，我推测如果才用巴维西单抗单药治疗的话，有效率应该更高。临床试验采用和多西他赛联用，完全是在单药疗效未明的情况下为了保证病人安全而进行的妥协。

巴维昔单抗是一种抗体，它可以和多种氨磷脂aminophospholipid结合，通常正常细胞表面是没有这些氨磷脂的，这些氨磷脂指出现在肿瘤细胞和一些受病毒感染的细胞表面，于是巴维昔单抗引导人体的免疫系统精准攻击这些恶性细胞，副作用很低。

只要这套办法可行，对比现在比较普遍的有效率不高的针对基因突变靶向药物就显得技高一筹，以后还可以根据在癌细胞表面的更多化学物质表达开发出各式各样高效的抗癌药物。

癌症从绝症变成慢性病的日子已经离人类不远了。

维基
http://en.wikipedia.org/wiki/Bavituximab