Heaven or hell? Amgen tumor vaccine is about to be voted by FDA Expert Committee

Source: Biovalley 2015-02-13, February 13, 2015 In the past two years, immunotherapy of tumor has been recognized by the whole biomedical industry Almost all biomedical companies have established their own R & D projects in this field more or less As an old biomedical giant, Amgen is no exception Talimogene laherparepvec (t-vec), a tumor vaccine developed by the company, is about to enter the approval process Prior to the FDA's final decision, two expert committees under the FDA will review the effectiveness of the vaccine in advance T-vec is produced by a genetically modified herpes simplex virus The virus can target tumor cells and expand to kill them In addition, when tumor cells die and release the virus, it will stimulate the activation of the immune system, which will cause the immune system to kill tumor cells According to the latest three-phase Clinical Research Report on the treatment of melanoma disclosed by Amgen, t-vec can significantly reduce tumor volume, prevent tumor recurrence and improve median survival However, there are still some concerns behind these positive data In this clinical study, the sustained response rate of t-vec reached the experimental expectation and achieved its primary goal However, there was no significant difference in the improvement of overall survival rate at the secondary end point Although Amgen emphasized that the p value of the experimental group and the control group was only 0.051 But it is still likely to be a "stain" on the final approval of t-vec According to the FDA's requirements, the FDA's expert committee will vote on whether to recommend FDA to approve the product before April 29 this year, and the FDA is expected to make a final decision on whether to approve the product on October 27 this year At the same time, Amgen has not been idle, the company has been actively expanding the scope of application of the vaccine and trying to seek joint treatment and development of cancer with other drugs At present, the company has begun to study the combined treatment of t-vec and Squibb's best-selling melanoma drug yevoy In addition, the company also hopes to be able to combine with the PD-1 drug approved by MSD last year