Eli
Lilly announced that a late-stage trial of ramucirumab in patients with
metastatic gastric cancer met its main goal of improving overall survival
compared to placebo. "We are pleased with this data of ramucirumab used as
monotherapy in a second-line setting in this difficult-to-treat disease,"
remarked Richard Gaynor, vice president of product development and medical
affairs at the company's oncology unit.
The
REGARD study randomised patients with metastatic gastric or gastroesophageal
junction adenocarcinoma following disease progression on first-line platinum-
or fluoropyrimidine-containing combination therapy to receive best supportive
care either in combination with ramucirumab or placebo. The drugmaker noted
that ramucirumab also prolonged progression-free survival versus placebo, which
was a secondary goal of the trial.
Eli
Lilly indicated that based on the results, which are the first Phase III data
read-out for ramucirumab, it will discuss plans for marketing applications with
regulators. The company added that data from the study will be presented at a
future medical meeting. Ramucirumab is a fully-human IgG1 monoclonal antibody
receptor antagonist designed to target the VEGF receptor-2.
Gaynor
noted that the study "reinforces our confidence in the ramucirumab
development programme, in which we currently have six Phase III studies ongoing
in five tumour types - breast, colorectal, gastric, hepatocellular and lung
cancer." The company said that the late-stage RAINBOW trial, which is
investigating ramucirumab in combination with paclitaxel in patients with
metastatic gastric cancer, completed enrolment last month.
ISI
Group analyst Mark Schoenebaum suggested that if approved, the drug, which Eli
Lilly gained through its 2008 purchase of ImClone Systems, could garner peak annual
sales of $600 million. "Overall, the Street will view [the results]
positively, we think, as it adds credence to the pipeline thesis,"
Schoenebaum commented.
Por:
Matthew Dennis
