CHMP recommends approval of Tecentriq in combination with amatin and chemotherapy for first-line treatment in Patients with NSq NSCLC

recently, Swisspharmaceutical(http://giant Roche announced that the EuropeanMedicines(http://Authority (http://(http://Products for human medicine
(http://)(http:// has issued an active review, recommending the approval of PD-L1 tumor immunotherapy Tecentriq (atolisolisolisolis) For first-line treatment for patients with metastatic non-squamous non-small cell lung cancer (NSq NSCLC) without EGFR or ALK genomic tumor distortionCHMP's positive opinion is based on data from the Phase III Clinical Study IMpower150 (NCT02366143)this study is a multicenter, open label, randomized, controlled study conducted in patients with stage IV or recurrent NSq NSCLC who have not previously undergone chemotherapy to control advanced disease, and evaluated the efficacy and safety of Tecentriq's combination with chemotherapy (purple sequoia and cacrel) or non-use of Avastin for first-line therapyA total of 1,202 patients were enrolled in the study, of which 1,045 were patients in the clinical lyse wild type (ITT-WT) subgroup, which excluded EGFR and ALK mutationsIn the study, patients were randomly enrolled in three treatment groups with a ratio of 1:1:1: Group A (Tecentriq plus chemotherapy), Group B (Tecentriq and Avastin plus chemotherapy), and Group C (Avastin-chemotherapy)The common primary endpoint of the study was a comparison of total survival (OS) and non-progressive survival (PFS) in itT-WT subgroup patients assessed by the researchers using the solid tumor efficacy evaluation criteria 1.1 (RECIST v1.1) Key secondary endpoints include PFS, OS, and security assessed by researchers in the ITT group 　　The results showed that in the active treatment of wild type (ITT-WT) subgroup: compared to avastin-avastin-chemotherapy regimen, tecentriq-Avastin-chemotherapy regimen programme significantly extended OS (median OS: 19.2 months vs 14.7 months, HR-0.78,95%CI: 0.64-0.96, p-0.0) 16), 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 : 55% vs 42%), extended mitigation duration (median DoR: 10.8 months vs 6.5 months) in study, tecentriq's combined drug safety was consistent with previous studies and found no new safety signals