GSK的MAGE-A3肿瘤疫苗倒下了

The investigational MAGE-A3 antigen-specific cancer immunotherapeutic does not meet first co-primary endpoint in Phase III melanoma clinical trial
- In line with the Independent Data Monitoring Committee’s (IDMC) unanimous recommendation, GSK will continue the DERMA trial until the second co-primary endpoint is assessed

GlaxoSmithKline plc (LSE:GSK) today announced that an independent analysis of the DERMAi study, a Phase III randomised, blinded, placebo-controlled trial of the MAGE-A3 cancer immunotherapeutic,showed that the study did not meet its first co-primary endpoint as it did not significantly extend disease-free survival (DFS) when compared to placebo in the MAGE-A3 positive population.

The DERMA study evaluated the efficacy and safety of the MAGE-A3 cancer immunotherapeutic in Stage IIIB/C melanoma patients with macroscopic nodal disease, whose tumours expressed the MAGE-A3 gene and had their tumours removed surgically.  MAGE-A3 is a tumour-specific antigen that is expressed in a variety of cancers, including melanoma with no presentation in normal cells. MAGE-A3 is expressed in about 65% of Stage III melanomas.

In line with the Inependent Data Monitoring Committee’s (IDMC) unanimous recommendation, GSK will continue the DERMA trial until the second co-primary endpoint is assessed. This endpoint, DFS in the gene signature positive sub-population, is designed to identify a subset of MAGE-A3 positive patients that may benefit from the treatment. Results from this analysis are expected in 2015. Until then, GSK will remain blinded to all safety and efficacy data.

The IDMC for the DERMA study indicated that the current review of the safety information raised no concern for the continuation of the trial.

“We want to thank all patients, their families and healthcare workers for their involvement in the trial and we remain committed to identifying a patient sub-population who may benefit from this investigational treatment,” commented Vincent Brichard, Senior Vice-President & Head of Immunotherapeutics, GSK Vaccines.

GSK is continuing to evaluate the same investigational MAGE-A3 cancer immunotherapeutic in another independent Phase III study (MAGRIT) in Non Small Cell Lung Cancer (NSCLC) following surgical removal of the primary tumour with first data anticipated in the first half of 2014.

在III期临床试验DERMA中，DPS与安慰剂组无显著差异，但试验还将在NSCLC患者中继续，等2015年的二级终点（病人亚群的DPS）

不知该说是意料之中呢还是意料之外

还是等着PD-1的疫苗吧，那个靠谱些。

抗PD-1治疗，在三种肿瘤中有效




       理念：通过中和使肿瘤逃避免疫系统的中PD-1，PD-L1，这样免疫针对性的方法产生了前所未有的肿瘤反应率。该抗体封锁了PD1和PD-L1，“可能为抗肿瘤活性的免疫治疗提供一个新的标准”伴随文章出版的新英格兰杂志的医学编辑Antoni Ribas博士这样评价。




       结果：在PD-1试验中，累计有效率率分别为在非小细胞肺癌（NSCLC）18％，28％的黑色素瘤患者和27％的肾细胞癌患者。在非小细胞肺癌中，抗PD-1治疗在鳞状和非鳞状细胞亚型都显示了的活性。PD-1在肺癌治疗中展示了惊人的反应，“任何肿瘤都可能通过适当免疫激活来表达免疫原性”研究人员写道

希望早点来到

看不懂啊 有翻译版吗

失望！
黑色素瘤是对免疫治疗最可能有效的肿瘤之一。如果这都没有效，那么在其他肿瘤中有效的机会就小了。