Ten years of major liver cancer Roche Tecentriq+Avastin combination phase III clinical significantly prolongs overall survival and progression-free survival!

November 26, 2019 / BIOON / -- Roche recently announced cancer at the Asia Conference of the European Society of Oncology (ESMO) in Singapore Immunotherapy tecentriq (atezolizumab, anti-PD-L1 antibody) combined with Avastin (Avastin, general name: bevacizumab, bevacizumab) in the treatment of liver cell carcinoma (HCC) phase III clinical study of imbrave150 (nct03434379) positive results Imbrave150 is an open label, multicenter, randomized phase III study in patients with unresectable HCC who have not previously received systematic treatment It is investigating the efficacy and safety of the combination of tecentriq and Avastin compared with the standard nursing drug sorafenib The results showed that the study reached the main end point: compared with sorafenib, the combination of tecentriq and Avastin improved the overall survival (OS) and progression free survival (PFS) statistically and clinically Specific data: compared with sorafenib, tecentriq + Avastin combined therapy reduced the risk of death (OS) by 42% (HR = 0.58, 95% CI: 0.42-0.79, P = 0.0006) and the risk of disease stress or death (PFS) by 41% (HR = 0.59, 95% CI: 0.47-0.76, P < 0.0001) In this study, the safety of the combination of tecentriq and Avastin was consistent with the known safety of each drug, and no new safety signal was found HCC is a major cause of death in the world, especially in Asia HCC is the most common type Based on the above results, imbrave150 is the first phase III cancer immunotherapy study to show improvement in OS and PFS in the most common treatment of liver cancer The combination of tecentriq and Avastin is also the first treatment to improve overall survival in patients with non resectable HCC who have not previously received systematic treatment in more than a decade The data from the imbrave150 study will be submitted to regulators around the world, including the U.S Food and Drug Administration (FDA), the European Drug Administration (EMA), and the National Drug Administration of China (nmpa) Dr Levi Garraway, Roche's chief medical officer and head of global product development, said: "for the first time in a decade, we have seen a treatment that improves the overall survival of patients with unresectable HCC compared to current treatment standards The combination of tecentriq and Avastin may bring about a revolution in the treatment of this invasive cancer We are working closely with global regulators to bring this treatment to patients as soon as possible " Roche has developed a wide range of clinical trial development projects for tecentriq, including ongoing or planned studies, including multiple phase III studies, involving various types of lung cancer, urogenital system cancer, skin cancer, breast cancer, gastrointestinal cancer, gynecological cancer and head and neck cancer This includes studies to evaluate the single drug of tecentriq and its combination with other drugs In July 2018, according to the data of an ongoing stage IB cancer immunotherapy combination study (nct02715531), the U.S FDA awarded tecentriq and Avastin initial (first-line) treatment breakthrough drug qualification (BTD) for advanced or metastatic liver cancer (HCC) This is an open label, multicenter study that is evaluating tumor immunotherapy tecentriq in combination with Avastin and / or other drugs for solid tumor patients Group A (non randomized) and group F (randomized) of this study included patients with unresectable HCC who had not previously received systematic treatment All patients in group a received tecentriq + Avastin combined therapy, while those in group F received tecentriq and Avastin combined therapy or tecentriq single drug treatment in a ratio of 1:1 Data for groups A and F were presented at the 2019 annual meeting of the European Society of Oncology (ESMO) at the end of September this year Group a data showed that the primary efficacy endpoint of objective response rate (ORR) was achieved: the median follow-up was 12.4 months, and the combination of tecentriq and Avastin showed significant and long-lasting clinical response The orr was 36% (95% CI: 26-46), the complete response rate (CR) was 12%, and the median response duration (DOR) was not reached; the secondary endpoint, median progression free survival (PFS) was 7.3 months（ 95%CI:5.4-9.9）。 Group F data showed that the primary efficacy end point of PFS was achieved: adopt RECIST According to the central review of v1.1, the risk of disease progression or death was reduced by 45% in combination with recentriq and Avastin compared with recentriq alone The median follow-up of 6.6 months showed that recentriq and Avastin combined therapy had advantages over recentriq alone (HR = 0.55, 80% CI: 0.40-0.74, P = 0.0108) The median PFS of recentriq and Avastin combined therapy group was 5.6 months (95% CI: 3.6-7.4), while the single drug treatment group of tecentriq was 3.4 months (95% CI: 1.9-5.2) Two other secondary endpoints of group F are under evaluation, and the data are not mature at present Tecentriq belongs to PD - (L) 1 tumor immunotherapy It aims to bind to a protein named PD-L1 expressed on tumor cells and tumor infiltrating immune cells, and block its interaction with PD-1 and B7.1 receptors By inhibiting PD-1, tecentriq can activate T cells, which has the potential to be used as a basic combination therapy for cancer immunotherapy, targeted drugs and various cancer chemotherapy Avastin is a kind of angiogenesis inhibitor, targeting to combine with vascular endothelial growth factor (VEGF) VEGF plays an important role in angiogenesis and maintenance in tumor life cycle Avastin can directly bind to VEGF to infect the blood supply of tumor and prevent it from interacting with receptors on vascular cells Tumor blood supply is considered to be the key to tumor growth and metastasis in vivo The combination of tecentriq and Avastin has a strong scientific basis, and the combination of tecentriq and Avastin has the potential to enhance the immune system against tumor Avastin not only has the established anti angiogenic effect, but also can further enhance tecentriq's ability to recover the body's anti-cancer immunity by inhibiting VEGF related immunosuppression, promoting tumor infiltration of T cells and activating the response of T cells to tumor antigens In December 2018, the US FDA approved tecentriq + Avastin + chemotherapy (carboplatin and paclitaxel) for the first-line treatment of adult patients with metastatic non squamous non-small cell lung cancer (NSQ NSCLC) without EGFR or ALK genomic tumor distortion This approval is based on data from patients in group B of the impower 150 study: in patients with intention to treat wild-type (itt-wt), tecentriq + Avastin + chemotherapy significantly prolonged the survival of patients compared with Avastin + chemotherapy (median OS: 19.2 months vs 14.7 months, HR = 0.78, P = 0.016) Source of the original text: Roche presents vital data monitoring questionnaire in combination with Avastin improvements overall survival in people with the most common form of life cancer