Lilly Announces Ramucirumab Phase III Lung Cancer Trial Meets Primary Endpoint of Overall Survival

Eli Lilly and Company 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. 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 programme, in which we have several Phase III and earlier-phase studies in multiple tumour types, both as a single agent and in combination with other therapies. Moreover, these data underscore Lilly's continued leadership in thoracic oncology."