Phase 3 Trial of BI 695502 Plus Chemotherapy Versus Bevacizumab Reference Product Plus Chemotherapy in Patients With Advanced Nonsquamous NSCLC
| Autor: | Bernd Liedert, Edward S. Kim, Sigrid Balser, Klaus B Rohr, Dorothee Schliephake, Ragna Lohmann |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Pulmonary and Respiratory Medicine
Oncology medicine.medical_specialty BI 695502 Bevacizumab medicine.medical_treatment chemistry.chemical_compound Maintenance therapy Internal medicine medicine Clinical endpoint Adverse effect Lung cancer RC254-282 Chemotherapy business.industry Biosimilar Non–small-cell lung cancer Neoplasms. Tumors. Oncology. Including cancer and carcinogens medicine.disease Carboplatin chemistry Response Evaluation Criteria in Solid Tumors Original Article business medicine.drug |
| Zdroj: | JTO Clinical and Research Reports JTO Clinical and Research Reports, Vol 3, Iss 1, Pp 100248-(2022) |
| ISSN: | 2666-3643 |
| Popis: | INTRODUCTION Biological therapies such as bevacizumab have improved survival in patients with non-small-cell lung cancer (NSCLC). This study was conducted to confirm equivalent efficacy of the biosimilar candidate BI 695502 to bevacizumab reference product (RP). METHODS In this phase III, multicenter, randomized, double-blind trial, 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 endpoint was 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 1:1 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 study. The primary endpoint, best ORR, was 54.0% in the BI 695502 group and 63.1% in the bevacizumab RP group. The 90% confidence interval for the between-group ratio of best ORR (0.770–0.951) was within the pre-specified range for equivalence (0.736–1.359). Adverse events were class-related and similar between the two treatment arms. CONCLUSIONS This study demonstrated equivalent ORR after 18 weeks of treatment with BI 695502 or bevacizumab RP, with similar adverse event profiles. |
| Databáze: | OpenAIRE |
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