Colorectal cancer "target + immune" treatment will meet a major breakthrough! Bayer and Bristol Myers work together to develop the combination scheme stivarga + opdivo!

July 19, 2019 / BIOON / - Bayer, BMS and Ono jointly announced that three companies had signed a clinical cooperation agreement to evaluate the tumor of stivarga and PD-1 Immunotherapy opdivo (common name: nivolumab, nevumab) combination therapy is used for the treatment of microsatellite stable metastatic colorectal cancer (MSS mCRC), which is the most common type of MCRC Further terms of the clinical cooperation were not disclosed In the MCRC critical phase III correct study, stivarga as a single drug therapy showed overall survival benefit compared to placebo, and in the retrospective analysis of the study showed activity unrelated to microsatellite status, although the observed remission was limited Although progress has been made in the treatment of colorectal cancer (CRC), including effective immunooncology (I-O) treatment for some CRC subgroups, about 95% of MCRC patients are microsatellite stable (MSS) tumors, in which the role of I-O monotherapy is limited As a result, there is still a high demand for other treatment options, including combination therapy The early data from the joint application of stivarga and opdivo is encouraging In a phase IB clinical trial sponsored by a Japanese researcher named regonivo (nct03406871, epoc1603), stivarga and opdivo showed good initial efficacy in the treatment of MSS gastric cancer (GC) and colorectal cancer (CRC) In this study, 50 patients were enrolled, including 25 GC patients and 25 CRC patients Except for one CRC with high microsatellite instability (MSI-H), all other CRC were MSS type All patients had received standard treatment, and the median of previous treatment was 3 (range: 2-8) The results showed that the median duration of treatment was 6.1 months, and the overall objective response rate (ORR) was 40%, in which the orr of GC patients was 44%, and that of CRC patients was 36% In addition to one MSI-H CRC patient, the orr of MSS CRC patients was still as high as 33% Partial remission was achieved in 3 of the 7 GC patients who had previously received PD-1 or PD-L1 treatment The overall median progression free survival (PFS) was 6.3 months, while GC and CRC patients were 5.8 and 6.2 months, respectively The detailed data of this study was published at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2019 (Abstract No.: 2522) Scott Z fields, MD, director of tumor development, Bayer pharmaceutical, said: "the data observed in the regonivo study will help to further explore the joint application of stivarga and opdivo in colorectal cancer patients Stivarga has proved its efficacy and positive safety as a three-line single drug therapy, and we are pleased to be able to carry out clinical cooperation to evaluate this combination treatment, and hope to provide additional treatment benefits for patients " The active drug component of stivarga is regiofenib, which is an oral multi kinase inhibitor It can effectively block multiple protein kinases involved in tumor angiogenesis (VEGFR-1, - 2, - 3, Tie2), tumorigenesis (kit, RET, Raf-1, BRAF), tumor metastasis (VEGFR3, PDGFR, FGFR), and tumor immunity (csf1r) Up to now, stivarga has been approved by more than 90 countries in the world, including the United States, the European Union, China and Japan, for the treatment of metastatic colorectal cancer (mCRC) The drug has also been approved by more than 80 countries in the world, for the treatment of metastatic gastrointestinal stromal tumor (GIST) and second-line treatment of liver cell carcinoma (HCC) Opdivo belongs to PD - (L) 1 tumor immunotherapy, which is the most attractive tumor immunotherapy at present It aims to use the human body's own immune system to resist cancer, and block the PD-1 / PD-L1 signal pathway to make cancer cells die It has the potential to treat various types of tumors Opdivo was approved in July 2014, becoming the first PD-1 immunosuppressant in the world to obtain regulatory approval Ono pharmaceutical is the original developer of opdivo In 2011, the company entered into a cooperation with Bristol Myers Squibb to authorize the development and commercialization rights of Bristol Myers Squibb except Japan, South Korea and Taiwan Up to now, the drug has been approved in 65 countries around the world, and has become an important treatment option for a variety of cancers Original source: Bayer, Bristol Myers Squibb and Ono pharmaceutical enter in to a clinical collaboration agreement to investigate stivarga (regorafenib) and Opera (nivolumab) as combination therapy in patients with color cancer