Background: Onartuzumab is a monovalent monoclonal antibody that binds with the extracellular domain of the MET receptor. Given the role of MET in non-small-cell lung cancer (NSCLC), we investigated whether onartuzumab added to first-line chemotherapy efficacy in non-squamous NSCLC.
Methods: Patients with untreated stage IIIB/IV non-squamous NSCLC, stratified by MET diagnostic status, were randomized to receive onartuzumab (15 mg/kg intravenously every 3 weeks) or placebo in combination with either paclitaxel/platinum/bevacizumab (bevacizumab cohort), or in combination with platinum/pemetrexed (pemetrexed cohort) with maintenance bevacizumab or pemetrexed and onartuzumab/placebo as appropriate. Co-primary endpoints of this phase II study were progression-free survival (PFS) in all patients and in MET+ patients (2+/3+), defined by the Ventana immunohistochemistry assay; secondary endpoints included overall survival (OS), objective response rate (ORR), safety, and pharmacokinetics.
Results: Efficacy data were available for 139 and 120 patients in the bevacizumab and pemetrexed cohorts, respectively. No benefit was seen in the PFS endpoint in the intent-to treat population of either cohort, but was numerically worse in the onartuzumab arm of the MET+ subgroup of the bevacizumab cohort. The onartuzumab and placebo arms had similar ORR and OS results in both cohorts. A higher incidence of some adverse events was observed with onartuzumab versus placebo, including peripheral edema (30% vs. 3%, bevacizumab cohort; 48% vs. 14%, pemetrexed cohort) and venous thromboembolic events (bevacizumab cohort only, 15% vs. 6%).
Conclusion: Onartuzumab does not appear to provide any additional clinical benefit when given in combination with current first-line standard-of-care chemotherapy for non-squamous NSCLC.
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http://dx.doi.org/10.1016/j.cllc.2016.09.013 | DOI Listing |
J Vitreoretin Dis
December 2024
Cleveland Clinic Cole Eye Institute, Cleveland, OH, USA.
To evaluate the effect of antivascular endothelial growth factor (anti-VEGF) agents on the development of sustained intraocular pressure (IOP) elevations. This single-center retrospective cohort study included eyes receiving anti-VEGF injections for various indications along with nontreated fellow eyes from 2012 to 2022. Patients were grouped according to treatment with bevacizumab, ranibizumab, or aflibercept.
View Article and Find Full Text PDFWorld J Gastrointest Oncol
December 2024
Department of Medical Oncology, Bower Hospital, Diyarbakır 21100, Türkiye.
Drug Target Insights
December 2024
Department of Medicine-Ophthalmology, University of Udine, Udine - Italy.
Objectives: To assess through an indirect treatment comparison (ITC) the potential benefit of faricimab over the anti-vascular endothelial growth factor (VEGF) real-life scenario, hereby defined standard of care (SoC), in Italy, that is, aflibercept, bevacizumab, and ranibizumab, in patients with neovascular age-related macular degeneration (nAMD) naïve to any anti-VEGF treatment.
Methods: Individual patient-level data from the phase III clinical trials TENAYA and LUCERNE (faricimab cohort) and the real-world study RADIANCE (RADIANCE cohort) were used. Efficacy was evaluated with changes in best corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline to 1 year (week 52 in the RADIANCE and week 48 in the faricimab cohorts, respectively).
Int J Clin Oncol
December 2024
Data Management Department, Drug Safety Division, Chugai Pharmaceutical Co., Ltd., Chuo-Ku, Japan.
Background: Febrile neutropenia (FN) is a recognised adverse event associated with chemotherapy. This study investigates the impact of atezolizumab, an immune checkpoint inhibitor, on the incidence of FN in patients with non-small cell lung cancer receiving concurrent chemotherapy in Japan.
Methods: This post-marketing database study was conducted using data from patients with non-small cell lung cancer provided by Medical Data Vision Co.
Oncologist
December 2024
Department of Oncology, Mayo Clinic, Rochester, MN, United States.
Background: Atezolizumab plus bevacizumab (A/B) received FDA approval as the first-line therapy for patients with advanced hepatocellular carcinoma (HCC) in 2020. However, optimal subsequent treatment options are unclear. Here, we describe clinical outcomes of advanced HCC patients following first-line treatment with A/B.
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