Lilly's ramucirumab may bring new hope to patients with gastric cancer after late-stage data indicated that the drug can extend overall survival.
The Phase III REGARD trial of ramucirumab hit its primary endpoint in showing improved overall survival in patients with advanced stages of disease, but also met a secondary goal of prolonging progression-free survival, the firm noted.
The study compared Lilly's drug - a fully-human IgG1 monoclonal antibody receptor antagonist targeting the VEGF receptor-2 - and best supportive care to placebo/best supportive care in the second-line treatment of metastatic gastric and gastroesophageal junction cancers.
Lilly said it is "pleased" with the data, claiming that it reinforces confidence in its ramucirumab development programme, which currently houses six live Phase III studies across five tumor types: breast, colorectal, gastric, hepatocellular and lung cancer.
REGARD is one of two late-stage trials looking at the drug in gastric cancer; the Phase III RAINBOW is assessing a combination of ramucirumab and paclitaxel, and patient enrollment was completed last month.
Further details of the results were not provided at this point, but the US drugmaker said it intends to presents its data at an upcoming scientific community, and, crucially, said it will be discussing plans to submit marketing applications with regulatory authorities.
Mark Schoenebaum, analyst at ISI Group, has reportedly forecast that, if the drug makes it to market in the gastric cancer setting, it could pull in peak sales of around $600 million a year.