Treatment of liver cancer, the new drug achieved excellent clinical data of 3 phases
January 18, 2018 Source: WuXi PharmaTech
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)];Exelixis and Ipsen today disclosed detailed results of a key phase III clinical trial, CELESTIAL, in which patients with advanced hepatocellular carcinoma (HCC) who underwent prior treatment achieved the primary endpoint of the study, statistically significant. Clinically prolonged patient overall survival (OS). The study will be presented at the ASCO-GI Symposium in San Francisco from January 18th to 20th, 2018.
Liver cancer is the third leading cause of death in the world, and hepatocellular carcinoma is the most common form of liver cancer. If left untreated, patients with advanced liver cancer usually cannot survive for more than 6 months. It is estimated that 29,000 of the 41,000 new cases of liver cancer in the United States will die of liver cancer in 2017.
Cabozantinib is a small molecule inhibitor that effectively inhibits receptor targets including MET, AXL, and VEGFR-1, VEGFR-2, and VEGFR-3. These receptors are involved in a series of disease-related processes such as tumor angiogenesis, invasion, metastasis and drug resistance. CABOMETYX tablets are approved for the treatment of patients with advanced renal cell carcinoma (RCC) in the United States. CABOMETYX tablets have also been approved by the European Union, Norway, Iceland and Switzerland for advanced RCC adult patients who have received prior vascular endothelial growth factor (VEGF) targeted therapies.
CELESTIAL is a randomized, double-blind, placebo-controlled phase 3 clinical trial of cabozantinib for treatment of HCC patients in more than 100 clinical centers in 19 countries around the world. The trial enrolled 760 patients with advanced HCC who had received sorafenib and may have received two systemic treatments for HCC with adequate liver function. Patients were randomized to a 2:1 ratio to a treatment group receiving 60 mg of cabozantinib or a placebo control group daily. The primary endpoint was overall survival, and secondary endpoints included objective response rate (ORR) and progression-free survival ( PFS). Exploratory endpoints include patient reported results, biomarkers, and drug safety.
In CELESTIAL, in the second interim analysis of the plan (pre-specified critical p-value ≤ 0.021), patients with second- and third-line patients receiving cabozantinib had statistically significant and clinically significant extensions compared with patients receiving placebo. Survival period. The median OS of cabozantinib was 10.2 months and the placebo group was 8.0 months (HR 0.76, 95% CI 0.63-0.92; p = 0.0049). The median progression-free survival (PFS) was more than doubled, with 5.2 months in the cabozantinib group and 1.9 months in the placebo group (HR 0.44, 95% CI 0.36-0.52; p <0.0001). The objective response rates for RECIST 1.1 were 4% for cabozantinib and 0.4% for placebo (p = 0.0086). Disease control (partial relief or stable disease) reached 64% in the cabozantinib group and 33% in the placebo group. In a subgroup analysis, the only previous treatment regimen for patients with advanced HCC was sorafenib (70% of patients in the study), and the median OS of patients receiving cabozantinib was 11.3 months compared with placebo It was 7.2 months (HR 0.70, 95% CI 0.55-0.88). The median PFS was 5.5 months in the subgroup and 1.9 months in the placebo group (HR 0.40, 95% CI 0.32-0.50). Adverse events were consistent with known cabozantinib safety.
â–²Cabozantinib molecular structure (Source: Wikipedia)
Dr. Ghassan K. Abou-Alfa, Ph.D., chief researcher at the Memorial Sloan Kettering Cancer Center and CELESTIAL in New York, said: "The prognosis of patients with advanced hepatocellular carcinoma is often poor, and treatment options are limited after systemic therapy. The CELESTIAL trial showed that clinically significant overall survival and progression-free survival showed that cabozantinib may be an important supplement to these patients if approved."
Dr. Gisela Schwab, President and Chief Medical Officer of Product Development and Medical Affairs at Exelixis, said: "We are excited about the efficacy of cabozantinib in patients with previously treated advanced hepatocellular carcinoma. Given the wide range of advanced hepatocellular carcinomas worldwide. It is still an urgent task to bring new treatment options to this patient group. We look forward to submitting a new drug application for cabozantinib to the FDA in the first quarter of 2018, and further advance our mission to help cancer patients recover and prosper. life."
Alexandre Lebeaut, chief scientific officer and executive vice president of research and development at Ipsen, said: "Patients diagnosed with advanced hepatocellular carcinoma urgently need new treatment options. The positive results of the key phase 3 CELESTIAL trial are encouraging for both doctors and patients. We have committed to submit a preliminary application change to the EMA and other relevant regulatory agencies in the first half of 2018."
We look forward to the successful implementation of this new drug in the next regulatory application, and the early listing will bring more treatment options and restore health for patients with liver cancer.
Reference materials:
[1] Exelixis, Ipsen Show Off Liver Cancer Success in Phase III Trial
[2] Exelixis and Ipsen Announce Phase 3 Trial Results of Cabozantinib Demonstrating Significant Overall Survival Benefit in Patients with Previously Treated Advanced Hepatocellular Carcinoma
[3] WuXi PharmaTech WeChat public number - extended overall survival! Excellent clinical results of liver cancer new drug phase 3
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