--葛兰素史克（GSK）9月5日公布了有关治疗性疫苗MAGE-A3的III期DERMA研究的独立分析数据，结果表明，与安慰剂相比，MAGE-A3未能显着改善MEGA-A3阳性群体无病生存期（DFS），未能达到该项研究的首个主要终点。

根据独立数据检测委员会（IDMC）的建议，GSK将继续推进DERMA试验，直到第2个主要终点完成评估，即鉴定出可能能够从治疗性疫苗MAGE-A3中受益的MAGE-A3阳性黑色素瘤亚组群体。该项分析数据，预计将于2015年获得。在此之前，GSK仍将保持所有安全性和疗效数据封盲（blinding）。

DERMA是一项随机、盲法（blinding）、安慰剂对照III期试验，旨在评价治疗性疫苗MAGE-A3治疗IIIB/C阶段MAGE-A3呈阳性黑色素瘤（melanoma）的疗效和安全性。试验中的患者，其黑色素瘤表达MEGA-A3蛋白，并已通过手术切除。

MEGA-A3蛋白是一种肿瘤特异性抗原，表达于多种癌症中，但不表达于正常细胞中。MEGA-A3蛋白表达于约65%的III阶段黑色素瘤。

目前，GSK正在开展另一项独立III期研究（MAGRIT），该研究在已手术移除原发肿瘤的非小细胞肺癌（NSCLC）患者中开展，评价治疗性疫苗MAGE-A3的疗效和安全性，首批数据预计将于2014年上半年获得。

分析师们认为，在GSK研发管线中，治疗性疫苗MAGE-A3和一种名为darapladib的心脏药物，有望成为年销售额达数十亿美元的重磅药物。darapladib开发用于治疗动脉阻塞（clogged arteries），其作用模式不同于他汀类药物。

MAGE-A3治疗性疫苗不同于传统的预防性疫苗，而是一种抗癌免疫疗法，该疗法旨在用于已患病的群体，帮助其免疫系统攻击癌症。

英文原文：GSK cancer vaccine misses target in melanoma trial

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.

Issued: Thursday 5 September 2013, London UK –LSE announcement

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,ii showed that the study did not meet its first co-primary endpoint as it did not significantly extend disease-free survival (DFSiii) 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.