The longest survival period is more than 3 years, and the new glioma vaccine brings new hope.
June 7, 2018 Source: CPhI Pharma Online Author: The red leaf
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Gliomas are the most common malignant tumors in the brain, accounting for 35.26% to 60.9% of intracranial tumors. Current treatments for glioma include surgical resection, chemotherapy and radiotherapy. Despite the combined use of these various treatments, the survival of glioma patients has not improved much. One of the important reasons is that gliomas continue to invade the surrounding normal brain tissue. Even in the brain tissue away from the tumor, the infiltration of malignant cells is often found. Therefore, it is difficult to remove all tumor cells during surgery, which often leads to postoperative Tumor recurrence. Therefore, enhancing the targeting effect of the body's immune system on glioma cells through various means has become an important treatment for us against cancer.
Recently, Northwest Bio, which specializes in the development of individualized cancer vaccines, published the results of a phase III clinical trial showing that the dendritic cell vaccine DCVax-L improves the survival rate of patients with newly diagnosed glioblastoma, the longest survival period. More than 3 years, it has exceeded 2 to 3 times of standard treatment, and the relevant data is published in the Journal of Translational Medicine.
Test details
This is a double-blind, placebo-controlled phase III clinical trial. From July 2007 to November 2015, a total of 331 newly diagnosed glioblastoma patients were enrolled in the study. The enrollment conditions ranged from 18 to 70 years old. The primary end point was progression-free survival (PFS). The end point is the overall survival (OS), which was conducted in more than 80 locations in four countries, the United States, Canada, Germany, and the United Kingdom. The 331 patients enrolled in the trial were randomized into two groups. 232 patients received standard treatment (ie, chemotherapy and radiotherapy after surgical removal of the tumor) plus DCVax-L vaccine, and the remaining 99 patients received standard treatment plus placebo. All patients are allowed to receive vaccine treatment after tumor progression or relapse. In the end, about 90% of patients received DCVax-L vaccine treatment.
Efficacy
The study found that patients from both groups had a median survival of 23.1 months after surgery, and the median survival time was extended by 8 months compared with the standard treatment alone in the previous study. As of the publication of the paper, 223 patients had a postoperative survival of more than 30 months, and 100 patients had a postoperative survival of 40.5 months. The median survival of these patients is expected to be 46.5 to 88.2 months. It is speculated that the good prognostic factors are: younger than 50 years old, methylated MGMT gene and surgery to completely remove all tumors and so on. The data also shows that once patients have survived for more than a certain period of time, they are likely to "continue to survive for a considerable period of time." All patients were enrolled in the trial in 2015, but are still in progress until enough patients develop disease progression and/or death to clarify the tail of the survival curve.
safety
The incidence of serious adverse events was 2% in this trial, and the overall incidence of adverse events was comparable to standard treatment.
The principle of DCVax-L vaccine
DCVax-L is a DC (dendritic cell) vaccine for autologous tumor cell lysates in patients with pleomorphic glioblastoma. The DCVax platform is designed to create individualized biomarkers for tumors in patients. therapy. Dendritic cells are extracted from the patient and then mixed with the patient's own tumor antigen for "activation" treatment. When injected back into the patient, the immune system in the patient recognizes the tumor and attacks.
DCVax-L vaccine won Britain's first "potential new medicines" Qualifying
In 2015, the UK Medical and Healthcare Products Authority (MHRA) awarded DCVa xL the "Potential Innovative Medicine" (PIM) qualification. The DCVa xL vaccine is the first "potential innovative drug" granted by MHRA since the launch of the New Drug Trial Program (EAMS) in April 2015. This innovative drug certification is considered a British "breakthrough drug" review.
About Northwest Bio Company
Northwest Bio is a biotechnology company focused on developing cost-effective, personalized immunotherapeutic products in North America and Europe that are designed to treat cancer more effectively than existing therapies without producing a chemotherapy-related Series toxicity. Northwest Bio also previously conducted a Phase I/II trial with the University of Pennsylvania to test the efficacy of DCVax-L in the treatment of metastatic ovarian cancer.
Clinical trials of DCVax-L vaccine for glioma have shown that patients' survival is significantly longer than expected, so researchers will continue to monitor patients to assess the final difference in long-term survival.
The goal of glioma immunotherapy is to use the patient's own immune system to identify and remove tumor cells with a high degree of specificity. This potent and specific anti-tumor immune response is expected to prolong the lives of patients, improve the quality of life of patients, and even cure cancer patients.
Reference source:
1. Northwest Bio official website
2.https://
3.First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioma
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