domingo, 11 de novembro de 2012

Eli Lilly's ramucirumab improves survival in Phase III gastric cancer study



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