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Phase 3 Trial of BI 695502 Plus Chemotherapy Versus Bevacizumab Reference Product Plus Chemotherapy in Patients With Advanced Nonsquamous NSCLC by Edward S. Kim; Sigrid Balser; Klaus B. Rohr; Ragna Lohmann; Bernd Liedert; Dorothee Schliephake is a Medicine article available to read on EtoBox.
What is Phase 3 Trial of BI 695502 Plus Chemotherapy Versus Bevacizumab Reference Product Plus Chemotherapy in Patients With Advanced Nonsquamous NSCLC about?
## Introduction: Biological therapies such as bevacizumab have improved survival in patients with nsclc. this study was conducted to confirm the equivalent efficacy of the biosimilar candidate bi 695502 to the bevacizumab reference product (rp). ## Methods: In this phase 3, multicenter, randomized, double-blind trial of adult patients with recurrent or metastatic nsclc received up to 18 weeks of induction treatment with bi 695502 or bevacizumab rp 15 mg/kg plus paclitaxel and carboplatin. subsequent maintenance therapy comprised bi 695502 or bevacizumab rp monotherapy until disease progression or unacceptable toxicity. the primary end point was the best overall response rate (orr) per response evaluation criteria in solid tumors version 1.1 assessed by central imaging review, until 18 weeks after the start of treatment. ## Results: In total, 671 patients were randomized at one-to-one ratio to bi 695502 or bevacizumab rp, of whom 335 and 328, respectively, received treatment. of these, 228 (68.1%) and 256 (78.0%), respectively, proceeded to maintenance monotherapy. a manufacturing issue led to a small number of patients treated with bi 695502 switching to bevacizumab rp late in the
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- Author
- Edward S. Kim; Sigrid Balser; Klaus B. Rohr; Ragna Lohmann; Bernd Liedert; Dorothee Schliephake
- Publisher
- Elsevier BV
- Published
- 2022
- Language
- EN
- Field
- Medicine (Health Sciences)