February 22nd, 2014
Lilly’s Ramucirumab for Lung Cancer Improves Survival in Late-Stage Trial
Lilly's Ramucirumab for Lung Cancer Improves Survival in Late-Stage Trial
02 19, 2014
Good News maybe Eli Lilly and Co said today that a phase III study of ramucirumab in patients non-small cell lung cancer (NSCLC) showed a statistically significant improvement in overall survival in the ramucirumab-plus-docetaxel arm compared to the control arm of placebo plus docetaxel.
The study 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 more than 1,200 nonsquamous and squamous NSCLC patients in 26 countries.
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," Dr. Richard Gaynor, senior vice president, product development and medical affairs for Lilly Oncology, said in a statement.
"Despite currently available therapies, there continues to be a need for new second-line treatment options for patients with lung cancer. 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," Dr. Gaynor said.
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