Tecentriq and Avastin chemotherapy triplets were approved immediately
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Last Update: 2021-02-09
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Source: Internet
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Author: User
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, the Swiss pharmaceutical giant, recently announced that the European Medicines Agency(EMA) Commission on Human Pharmaceutical Products (CHMP) has issued an active review recommending approval of the PD-L1 oncology immunotherapy Tecentriq (atezolizumab) in combination with A vastin, generic name: bevacizumab, beva monoantigen) and chemotherapy (yew alcohol and carpentry), for first-line treatment in patients with metastasis non-squamous non-small cell lung cancer (NSq NSCLC) without EGFR or ALC genomic tumor distortion.
, CHMP's advice will now be submitted to the European Commission (EC), which usually takes CHMP's advice when making a final review decision. This also means that the Tecentriq-Avastin-chemotherapy triple programme is likely to be approved within the next 2-3 months for the benefit of non-scale lung cancer patients in Europe. In the United States, Tecentriq was approved in December 2018.CHMP's positive comments are based on data from phase III clinical study IMpower150 Study (NCT02366143). The study, a multicenter, open-label, randomized, controlled study, was conducted in patients with stage IV or relapsed NSq NSCLC who had not previously received chemotherapy to control advanced diseases, and assessed the efficacy and safety of Tecentriq in combination with chemotherapy (yew alcohol-carpentin) or without Avastin for first-line treatment. A total of 1,202 patients were included in the study, of which 1,045 were intentional treatment of wild-type (ITT-WT) subgroup patients, who excluded EGFR and ALK mutations. In the study, patients were randomly assigned to three treatment groups in a 1:1:1 ratio: Group A (Tecentriq plus chemotherapy), Group B (Tecentriq plus Avastin plus chemotherapy), and Group C (Avastin plus chemotherapy). The common main endpoint of the study was a comparison between total survival (OS) and progress-free lifetime (PFS) in group B and group C patients assessed by the researchers using version 1.1 (RECIST v1.1) of the solid tumor efficacy evaluation standard. Key secondary endpoints include PFS, OS, and security assessed by researchers in the ITT community.results show that in the intentional treatment wild type (ITT-WT) sub-group: compared with the Avastin plus chemotherapy program, tecentriq and Avastin plus chemotherapy program significantly extended OS (medium OS: 19.2 months vs 14.7 months, HR=0.78,95%CI:0.64-0.96, p=0.96 016), significantly reduced the risk of disease progression or death by 29% (HR:0.71,95%CI:0.59-0.85, p=0.0002), reduced tumor volume (total remission rate (ORR): 55% vs 42%), and extended remission duration (medium DoR: 10.8 months vs 6.5 months). In the study, the safety of Tecentriq's combined medication was consistent with previous studies, and no new safety signals were found.currently working with the FDA on post-market commitments (PMCs) to better understand and describe the potential effects of Tecentriq-related anti-drug antibodies (ADA) and nAb. In the IMpower150 study, the results of the ADA analysis had no effect on tecentriq's efficacy.Tecentriq belongs to PD-(L)1 Tumor Immunotherapy, a high-profile type of tumor immunotherapy that aims to use the body's own immune system to fight cancer, kill cancer cells by blocking the PD-1/PD-L1 signaling path, and has the potential to treat multiple types of tumors. To date, Tecentriq has been approved by more than 80 countries worldwide: (1) for metastatic NSCLC patients with progression of the disease during or after platinum-containing chemotherapy and without EGFR or ALC tumor genomic distortion;lung cancer, Roche is conducting nine Phase III studies to assess Tecentriq's therapeutic potential as a single drug and in a joint drug with other drugs. (Bio Valley)
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