A global Phase III study (REVEL) of ramucirumab in combination with chemotherapy in patients with second-line non-small cell lung cancer (NSCLC), 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 (Press release Eli Lilly, FEB 19, 2014, View Source [SID:1234500091]). REVEL also showed a statistically significant improvement in progression-free survival in the ramucirumab arm compared to the control arm.
The global, randomized, double-blind REVEL trial compared ramucirumab and docetaxel 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 ( > 5% incidence) Grade > 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.
Lilly plans to present data from the REVEL trial at an upcoming scientific meeting and intends to submit the first application of these data to regulatory authorities in 2014.