Eli Lilly and Company, a global healthcare leader, has reported 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.
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.
"We are pleased with these phase III data of ramucirumab in non-small cell lung cancer, which accounts for most cases of lung cancer - the leading cause of cancer-related mortality worldwide. Despite currently available therapies, there continues to be a need for new second-line treatment options for patients with lung cancer," said Richard Gaynor, MD, senior vice president, product development and medical affairs for Lilly Oncology. " Revel is the first positive phase III study of a biologic in combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone in second-line non-small cell lung cancer."
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.
Dr Gaynor added, "These data reinforce our confidence in the overall ramucirumab development program, in which we have several phase III and earlier-phase studies in multiple tumor types, both as a single agent and in combination with other therapies. Moreover, these data underscore Lilly's continued leadership in thoracic oncology."
Revel is a global, double-blind, placebo-controlled phase III study of ramucirumab and docetaxel 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. Initiated in 2010, the global study enrolled more than 1,200 patients across 26 countries. The primary endpoint of the Revel trial is overall survival and secondary endpoints include: progression-free survival; objective response rate; quality of life; and safety. The study included nonsquamous and squamous NSCLC patients.
Ramucirumab (IMC-1121B) is designed to directly inhibit angiogenesis, a process by which blood vessels supply blood to tumours. Ramucirumab is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor (VEGF) receptor 2 and inhibits downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.
Ramucirumab, which Lilly gained through its 2008 acquisition of ImClone Systems, is being investigated in clinical trials as a single agent and in combination with other anticancer therapies for the treatment of multiple tumor types. The Revel lung cancer trial is the third positive phase III study of ramucirumab; all three of those studies demonstrated improved overall survival and progression-free survival. The first, which studied ramucirumab in gastric cancer as a single agent, is the basis for regulatory submissions in the US and EU; the second, which studied ramucirumab in gastric cancer in combination with paclitaxel, is a planned regulatory submission in 2014. Top-line results for phase III trials of ramucirumab in hepatocellular (liver) and colorectal cancer are expected in 2014.