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Amgen治疗黑色素瘤三期试验成功

2013-4-1 13:15:00
核心提示:  Amgen公司一项名为talimogene laherparepvec的利用抗肿瘤病毒来治疗黑色素瘤的三期试验获得理想数据。Amgen曾经透露公司利用改造后的唇疱疹病毒作为一个重要疗法进行抗癌研究。研究数据显示,相对于对照组,实验组中患者的病情有明显改善。Amgen公司表示,talimogene laherparepvec将为黑色素瘤的最终治愈提供重要帮助。(生物谷Bioon.com)...

 Amgen公司一项名为talimogene laherparepvec的利用抗肿瘤病毒来治疗黑色素瘤的三期试验获得理想数据。Amgen曾经透露公司利用改造后的唇疱疹病毒作为一个重要疗法进行抗癌研究。研究数据显示,相对于对照组,实验组中患者的病情有明显改善。Amgen公司表示,talimogene laherparepvec将为黑色素瘤的最终治愈提供重要帮助。(生物谷Bioon.com)

详细英文报道:

Amgen ($AMGN) touted top-line results from a Phase III trial of an anti-cancer virus as a treatment for a deadly form of skin cancer, showing that talimogene laherparepvec met the primary goal for shrinking tumors in patients with late stages of the disease. The data indicate that the biotech giant and ex-R&D chief Roger Perlmutter, the new research czar of Merck ($MRK), may have gambled wisely in acquiring the program and developer BioVex two years ago for up to $1 billion.

Last month Amgen highlighted the engineered cold sore virus as one of the most important advanced therapies in its pipeline, which is expected to yield late-stage data for 8 new treatments between this year and 2016. While Amgen R&D boss Sean Harper aims to pick winners based on matching drugs with genetically validated targets, he inherited talimogene laherparepvec and other late-stage candidates from his predecessor Perlmutter, who Merck announced would take over for Peter Kim as its top research exec earlier this month.

Talimogene laherparepvec (formerly OncoVex) could offer a new weapon against melanoma, which accounts for only 5% of skin cancers yet 75% of skin cancer deaths, according to figures cited by Amgen. Hitting its primary endpoint, the study showed that 16% of trial patients on the engineered virus had a durable response compared with 2% of those on the control therapy GM-CSF. Amgen also revealed a trend toward overall survival in favor of its virus compared with GM-CSF.

In the study of more than 400 patients, the most common serious adverse events included disease worsening, cellulitis and pyrexia. Chills and fatigue were among the frequent adverse events. Amgen plans to report more safety and efficacy data at the major annual ASCO meeting, which kicks off May 31. Overall survival data are expected in late 2013.

"These are the first Phase 3 results of this novel approach to cancer therapy," Amgen''s Harper said in a statement. "A high unmet need exists in melanoma and we believe the innovative mechanism of action of talimogene laherparepvec may offer a promising approach for these patients."

Amgen executives weren''t available for interviews about the program on Tuesday evening.

Thousand Oaks, CA-based Amgen scooped up the program via its March 2011 buyout of Woburn, MA-based BioVex (a 2009 Fierce 15 company) for $425 million upfront and up to $575 million milestones. Featuring a multi-pronged attack on tumors, talimogene laherparepvec is designed to replicate inside tumor cells until they burst as well as trigger immune responses against malignancies.

 

 

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