Ramucirumab Steams Ahead: Now Lung Cancer Trial Succeeds

Zosia Chustecka

February 19, 2014

The investigational drug ramucirumab (Lilly) is steaming ahead through clinical development. The company has just announced positive top-line results from a phase 3 trial in non-small cell lung cancer (NSCLC).

This is the third successful pivotal trial for the drug; the other 2 were in gastric cancer. In all of the 3 trials reported so far, it has shown a significant improvement in both overall and progression-free survival.

Two more pivotal trials, in hepatocellular and in colorectal cancer, are in progress, with results expected in 2014. But a large trial in breast cancer has failed.

Ramucirumab is an angiogenesis inhibitor, a targeted antibody that specifically blocks VEGF-2. It is seen as a successor to bevacizumab (Genentech/Avastin), and is predicted by analysts to have similar blockbuster sales potential.

Success in NSCLC Trial

The latest trial, known as REVEL, was a global phase 3 trial in more than 1200 patients with NSCLC (both squamous and nonsquamous) who had progressed after failure of platinum-based chemotherapy. Patients were randomized to received docetaxel alone or docetaxel with ramucirumab.

"REVEL is the first positive phase 3 study of a biologic in combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone in second-line NSCLC," the company said.

Full results of this study are due to be presented at an upcoming meeting, and the company plans to submit these data to regulatory authorities in 2014.

Success Also in Gastric Cancer

Ramucirumab is already awaiting approval for use in gastric cancer in both the United States and Europe. That application was based on the just-published REGARD trial, conducted in patients with advanced gastric cancer who had progressed after chemotherapy (Lancet. 2014;383:31-39). Monotherapy with ramucirumab showed an improvement in overall survival (5.2 vs 3.8 months with placebo), and was hailed by experts as a "new standard of care" when the results were presented at a meeting.

A second trial in gastric cancer, known as RAINBOW, involved a similar patient population and showed that the combination of ramucirumab with paclitaxel was superior to paclitaxel used alone as second-line therapy.

The company says that it plans to also submit these data for approval.

Failed in Breast Cancer

However, a phase 3 trial in breast cancer was not successful. Known as ROSE, this trial compared ramucirumab and docetaxel with placebo and docetaxel as a first-line treatment in 1144 patients with unresectable, locally recurrent, or metastatic HER2-negative breast cancer. It found no improvement in progression-free survival.

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