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.
Source: medspace