Roche Tecentriq's joint Avastin therapy was approved in Europe

November 2, Roche announced that the European Commission had approved Tecentriq® (atezolizumab) and Avastin® (bevacizumab, bevalumab) for the treatment of adult patients with advanced or non-removable hepatocellular carcinoma (HCC) who have not received systematic treatment.The approval is based on the results of Phase 3 clinical study IMbrave150, a global, multi-center, open-label study of 501 patients in the group who could not be removed from HCC without systematic treatment. The subjects were randomly divided into 2:1 and were treated with Tecentriq and beva monoantigen or soraphinib. Patients in the combined administration group were given Tecentriq 1200mg intravenously on the first day of every 21-day cycle and beva monoantigen 15mg/kg; Patients receive combined therapy or control group sorafeini treatment until the disease progresses or there is unacceptable toxicity. The two main endpoints are total survival rate (OS) and progress-free lifetime (PFS) assessed by the Independent Review Body (IRF) based on solid tumor version 1.1 (RECIST v1.1) response criteria. Other study endpoints include IRF evaluation of total efficiency (ORR) based on RECIST v1.1 and HCC mRECIST.The study showed that Tecentriq combined beval monoantigen reduced the risk of death (OS) by 42% compared to sorafenib (sorafenib; 95% CI: 0.42-0.79;; p -0.0006) and reduce the risk of disease deterioration or death (PFS) by 41% (HR=0.59; 95% CI: 0.47-0.76; p<0.0001). IMbrave150 was the first Phase 3 clinical cancer immunotherapy study to show that both OS and PFS in patients with liver cancer could not be removed (as compared to Solafini). In terms of safety, 57% of patients treated with Tecentriq combined beval monotherapy had level 3-4 adverse events, while 55% of patients treated with soraphinib had level 3-4 adverse events. The most common severe adverse reactions (≥2%) were gastrointestinal bleeding and fever.The approval follows a positive recommendation by the European Medicines Agency (EMA) Committee on Human Pharmaceutical Products (CHMP) in September 2020. In May 2020, the U.S. Food and Drug Administration (FDA) approved Tecentriq's combined treatment with Avastin for patients with non-removable or metastasis HCC who were not systematically treated. In addition, China's State Administration of Pharmaceutical Products has approved the combination therapy in October 2020 to treat non-removable HCC patients who have not previously received systematic treatment. In addition, Tecentriq and Avastin have recently been listed as class I recommended drugs recommended by the European Society of Medical Oncology (ESMO) for the treatment of HCC removal.

Tecentriq is a monoclonal antibody designed to bind to the PD-L1 protein, which is expressed on tumor cells and tumor-immersed immune cells, blocking its interaction with PD-1 and B7.1 receptors. Tecentriq activates T cells by inhibiting PD-L1. At the same time, as a cancer immunotherapy, the drug may be used as a fundamental joint partner with other immunotherapy, targeted drugs, and a wide range of chemotherapy therapies. Tecentriq has previously been approved for use alone or in combination with various forms of targeted therapy and/or chemotherapy for the treatment of non-small cell lung cancer, small cell lung cancer, certain types of metastatic urethroid skin cancer, and PD-L1-positive metastatic triple negative breast cancer. In the United States, Tecentriq has also been approved in association with Cotellic ® and Zelbaraf® (vemurafenib) to treat patients with advanced melanoma who are positive for the BRAF V600 mutation.Avastin is an intravenous biological antibody that binds specifically to a protein called endotent growth factor (VEGF), which plays an important role throughout the life cycle of the tumor and is used primarily to develop and maintain blood vessels, a process known as angiogenesty. Tumor blood supply is considered to be the key to tumor growth and diffusion (metastasis) in the body Avastin's role is to interfere with the tumor's blood supply by binding directly to the VEGF protein to prevent interaction with receptors on blood vessel cells and has anti-angiogenesic effects. In addition, Avastin can further enhance Tecentriq's ability to restore anti-cancer immunity by inhibiting VEGF-related immunosuppression, promoting T-cell tumor immersion, and initiating T-cell responses to tumor antigens. So a combination of Tecentriq and Avastin can enhance the immune system's potential to fight multiple cancers. (Sina Pharmaceutical News)reference source:tecentriq in the configuration with Avastin is first and only cancer immunotherapy regimen approved in Europe for the treatment of unresectable hepatocell carcinoma (HCC), the most common form of liver