Shots:

• The approval is based on P-III IMpassion130 study assessing Tecentriq + nab-paclitaxel vs PBO + nab-paclitaxel in 902 patients in ratio (1:1) with unresectable locally advanced or metastatic TNBC treated with no prior CT for disease
• P-III IMpassion130 study results: reduction the risk of disease worsening or death by 38%; mPFS (7.5 mos. vs 5 mos.); OS (25.0 mos. vs 18.0 mos.); no new safety signals observed. The PD-L1 status in IMpassion 130 study is assessed using VENTANA PD-L1 (SP142) assay in CE markets and available in the EU for identifying patients with TNBC eligible for treatment with the Tecentriq combination
• Tecentriq is a mAb binds with PD-L1 protein further blocking its interaction with PD-1 and B7.1 receptor and is being evaluated in 7 trials for TNBC including early and advanced stages of the disease. Additionally- the combination with Abraxane is the first immunotherapy regimen approved in Europe for TNBC

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 Ref: Roche | Image: Roche