Immunotherapy for liver cancer! Bristol Myers Squibb opdivo + yervoy combination entered the priority review in the United States for second-line treatment!

November 12, 2019 / BIOON / - tumor The US Food and Drug Administration (FDA) has accepted a supplementary biological product license application (SBLA) from opdivo (Chinese trade name: odivo, common name: nivolumab, nevulizumab) and yevoy (ipilimumab, eplimmma) immunotherapy combination (oy combination) submitted by BMS, an immunotherapy giant, recently announced BTD is used in patients with advanced HCC who have previously received oral kinase inhibitor sorafenib FDA will give priority to the review of the SBLA, and the target date of PDUFA is March 10, 2020 BTD is a new drug review channel established by FDA in 2012 It aims to accelerate the development and review of new drugs for the treatment of serious or life threatening diseases and has preliminary clinical evidence showing significant improvement in one or more clinically important endpoints compared with existing therapeutic drugs The drugs that obtain BTD can receive more close guidance, including FDA senior officials, during the research and development, so as to guarantee to provide patients with new treatment options in the shortest time The SBLA is based on data from the oy cohort of the ongoing phase I / II checkmate-040 study, which is evaluating the oy combination for patients with advanced HCC who have previously been treated with sorafenib The data have been published at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2019 The results showed that the objective response rate (ORR) and median response duration (DOR) were 31% and 17.5 months respectively Dr Ian M Waxman, head of gastrointestinal cancer development at BMS, said: "FDA accepts our oy portfolio application, which is an important development for liver cancer patients in the United States In the United States, HCC is the fastest growing cause of cancer-related deaths Although some progress has been made in recent years, HCC is still a kind of cancer that is difficult to treat, and patients need more effective treatment programs We look forward to working with FDA to bring the potential of dual immunotherapy to these patients for the first time " Liver cancer is the fourth leading cause of cancer death in the world, and HCC is the most common type of liver cancer and the fastest rising cause of cancer-related deaths in the United States Although some second-line drugs have been approved by FDA in recent years, the diagnosis of HCC is often late, with poor prognosis, highlighting the need for new treatment options Although most cases of liver cancer are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, the incidence rate of metabolic syndrome and non-alcoholic steatohepatitis (NASH) is rising and is expected to increase the incidence rate of liver cancer Opdivo and yevoy are tumor immunotherapy (I-O) They target different regulatory elements in the immune system and use the immune system of human body to fight against tumor Opdivo targets to block PD-1 / PD-L1 pathway, yevoy targets to block CTLA-4 In the United States, opdivo + yervoy immunotherapy has been approved for: (1) the treatment of unresectable or metastatic melanoma; (2) the first-line treatment of patients with advanced renal cell carcinoma (RCC); and (3) the treatment of children aged 12 and over and adults with high microsatellite instability (MSI-H) or mismatch repair defect (dmmr) metastatic colorectal cancer (CRC) At present, BMS is developing oy combination for the treatment of various types of tumors In October, the company released data from the critical phase III checkmate-9la trial for lung cancer The results showed that the study had reached the main end point of overall survival (OS) at the time of mid-term analysis The data confirmed the potential of opdivo combined with low-dose yervoy and two cycles of first-line chemotherapy for non-small cell lung cancer (NSCLC) In February this year, BMS also published the results of checkmate-650, a phase II clinical study of oy combination in the treatment of metastatic castrated prostate cancer (mcrpc) The data showed that oy combination showed strong evidence of efficacy in the treatment of mcrpc, which also made oy combination the first immunotumor with strong efficacy in this refractory patient group Learn (I-O / I-O) combination therapy Original source: U.S Food and Drug Administration acceptances for priority review Bristol Myers Squibb's application for opdivo (nivolumab) plus yevoy (ipilimumab) combination for patients with previously treated advanced hectococcular carinoma