Eli Lilly has announced that the REVEL trial, a global phase III study 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 ( Taxotere ).
REVEL has 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 has 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 designed to directly inhibit angiogenesis, a process by which blood vessels supply blood to tumors. Ramucirumab is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor receptor 2 ( VEGFR2 ) and inhibits downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.
Lung cancer is the leading cause of cancer death in the U.S. and most other countries, killing nearly 1.6 million people worldwide each year. In the U.S., lung cancer is responsible for nearly 30% of all cancer deaths, more than those from breast, colon and prostate cancers combined.
Stage IV NSCLC is a very difficult-to-treat cancer and the prognosis for patients with NSCLC is poor when locally advanced or metastatic.
NSCLC is much more common than other types of lung cancer, and accounts for 85% of all lung cancer cases. Patients with squamous cell carcinoma represent about 30% of all patients affected by NSCLC, while non-squamous patients represent about 70%. ( Xagena )
Source: Eli Lilly, 2014