Eli Lilly has announced that the randomized, double-blind, REVEL trial, a global phase III study of Ramucirumab in combination with chemotherapy in patients with second-line non-small cell lung carcinoma ( NSCLC ), has showed a statistically significant improvement in the primary endpoint of overall survival in the Ramucirumab - plus - Docetaxel arm compared to the control arm of placebo plus Docetaxel.
REVEL has also showed a statistically significant improvement in progression-free survival in the Ramucirumab arm compared to the control arm.
Ramucirumab and Docetaxel were compared to placebo and Docetaxel in NSCLC patients whose disease has progressed after failure of prior Platinum-based chemotherapy for locally advanced or metastatic disease.
The study included nonsquamous and squamous NSCLC patients.
The most common ( greater than 5% incidence ) grade greater than 3 adverse events occurring at a higher rate on the Ramucirumab - plus - docetaxel arm compared to the control arm were decreased white blood cell count ( neutropenia / leukopenia ), febrile neutropenia, fatigue / asthenia and hypertension.
Ramucirumab is a fully human monoclonal antibody ( IgG1 ) directed against the vascular endothelial growth factor receptor 2 ( VEGFR2 ). By binding to VEGFR2 it works as a receptor antagonist blocking the binding of vascular endothelial growth factor ( VEGF ) to VEGFR2.
VEGFR2 is known to mediate the majority of the downstream effects of VEGF in angiogenesis. ( Xagena )
Source: Eli Lilly, 2014