安进（Amgen）3月14日公布了实验性黑色素瘤疗法talimogene laherparepvec（T-Vec）一项关键性III期研究新的回顾性分析数据，记录到了肿瘤层面的反应率（tumor-level response）。数据显示，T-Vec缩小了已注射该药的肿瘤的体积，同时也缩小了转移至身体其他部位的肿瘤的体积，表明T-Vec触发了系统性（全身性）免疫反应。该项分析的完整数据已提交至3月14日举行的第67届肿瘤外科学会（SSO）癌症研讨会。
该项关键性III期试验在可注射未切除IIIB、IIIC、IV期黑色素瘤（melanoma）患者中开展，将T-Vec与粒细胞-巨噬细胞集落刺激因子（GM-CSF）进行了对比。该项研究的总生存期（OS）数据，预计将于2014年上半年获得。
新的回顾分析，对接受T-Vec治疗的295例患者近4000个肿瘤病灶进行了跟踪调查。这些病灶中，有一半病症注射了至少一次T-Vec，其余一半病灶（包括内脏肿瘤病变：累及实质器官如肝肺的肿瘤）未注射T-Vec。分析数据表明，已注射T-Vec的肿瘤病灶中，64%的病灶肿瘤体积减小50%或更多。此外，三分之一的未注射非内脏肿瘤、15%的内脏肿瘤，肿瘤体积也至少减小了50%。该项研究中，开展了35例黑色素瘤相关手术，其中30%手术成功移除了所有残留病灶。
此前，2013年6月公布的积极数据表明，该项研究达到了持久反应率（DRR）的主要终点，其定义为完全或部分反应缓解持续至少6个月。T-Vec组总缓解率为26%，GM-CFS组为6%。既定中期分析也观察到了总生存期（HR=0.79，95％CI，0.61-1.02）的积极趋势。
Talimogene laherparepvec(T-Vec)是一种实验性溶瘤免疫疗法（oncolytic immunotherapy），是一种基因工程化的病毒，能够表达GM-CFS。T-Vec直接注射入肿瘤，并能够在肿瘤细胞中复制直至细胞膜破裂及死亡（即细胞裂解），同时能够在肿瘤组织局部释放GM-CSF，这是一种白细胞生长因子，能够激活全身性免疫反应。T-Vec通过2种重要且互补的方式发挥作用：引发肿瘤组织溶解，同时激发一种全身性的抗肿瘤免疫反应。
该领域中，其他的新药包括免疫疗法（immunotherapies），如百时美施贵宝（BMS）的Yervoy，该疗法旨在利用人体的免疫系统来对抗黑色素瘤。目前，Amgen也正在其他类型肿瘤中评价T-Vec。同时也正在评价T-Vec和Yervoy组合疗法，并已同意开展研究调查T-Vec与默沙东PD-抑制剂组合疗法。
Amgen vaccine triggers immune response in advanced melanoma -study
Amgen's Talimogene Laherparepvec Reduced Size Of Melanoma Tumors In New Phase 3 Retrospective Analysis
Data Showed Tumor Shrinkage in Both Injected and Metastasized Tumors
Results from Amgen's Investigational Oncolytic Immunotherapy Presented Today at the Society for Surgical Oncology Congress in Phoenix
THOUSAND OAKS, Calif., March 14, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced findings from a pre-specified retrospective analysis of patients with metastatic melanoma that showed talimogene laherparepvec reduced the size of injected tumors and also non-injected tumors that had metastasized to other parts of the body. The analysis recorded tumor-level responses from a pivotal Phase 3 study evaluating talimogene laherparepvec in patients with injectable unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). Full results were presented today during an oral session at the Society of Surgical Oncology (SSO) 67th Annual Cancer Symposium in Phoenix.
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumor tissue and to initiate a systemic anti-tumor immune response.
Of the 295 patients treated with talimogene laherparepvec, almost 4,000 tumor lesions were tracked for this analysis. Half of these lesions were injected with talimogene laherparepvec at least once, while the rest were not injected, including visceral tumor lesions (tumors involving solid organs such as the lungs and liver). The results showed a 50 percent or greater reduction in tumor size in 64 percent of injected tumors. In addition, one-third of uninjected non-visceral tumors, and 15 percent of visceral tumors were also reduced by at least 50 percent. There were 35 melanoma-related surgeries performed during this trial of which 30 percent successfully removed all residual disease.
The most frequently observed adverse events in the Phase 3 study were fatigue, chills and pyrexia. The most common serious adverse events include disease progression in both groups, and cellulitis and pyrexia in the talimogene laherparepvec group. Serious adverse events occurred in 26 percent of talimogene laherparepvec patients and 13 percent of GM-CSF patients. Immune-mediated events were reported infrequently.
"These data add to the body of evidence supporting talimogene laherparepvec's local and distant effect, and its potential ability to stimulate a systemic anti-tumor immune response," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Melanoma remains a devastating and difficult-to-treat disease, and talimogene laherparepvec continues to demonstrate encouraging results in this setting."
About Talimogene Laherparepvec
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumor tissue and to initiate a systemic anti-tumor immune response. Talimogene laherparepvec is injected directly into tumor tissue and is intended to replicate preferentially in tumor cells causing lytic cell death and releasing an array of tumor-derived antigens. Talimogene laherparepvec is also engineered to express granulocyte-macrophage colony-stimulating factor (GM-CSF), a white blood cell growth factor, which can help to activate the immune system. The aim of this combination of actions is to initiate a systemic anti-tumor immune response that targets tumor cells throughout the body.
About Melanoma
Melanoma is a type of skin cancer that is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for providing the pigment to skin.1 Melanoma is the most aggressive and serious form of skin cancer. Currently, 132,000 melanoma cases occur globally each year.2 In the U.S., while melanoma accounts for less than 5 percent of skin cancer cases, it causes the most skin cancer deaths.2 The number of new cases of melanoma in the U.S. has been increasing for the last 30 years.2
Melanoma is considered to be advanced when it has spread, or metastasized, from the origin site to deeper parts of the skin or other organs such as the lymph nodes, lungs or other parts of the body distant from the primary tumor site.
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