Lilly Announces Ramucirumab Showed Prolonged Progression-Free Survival in Gastric Cancer Treatment

Eli Lilly and Company

today announced that the REGARD trial, a Phase III study of ramucirumab (IMC-1121B) in patients with metastatic gastric cancer, met its primary endpoint of improved overall survival and also showed prolonged progression-free survival. This trial is the first Phase III data read-out for ramucirumab. The REGARD trial compared ramucirumab and best supportive care to placebo and best supportive care as a second-line treatment in patients with metastatic gastric and gastroesophageal junction cancers. The most frequent adverse reaction (any grade) occurring at a higher rate on the ramucirumab arm was hypertension (12%). Other adverse reactions (>5%) occurring at a higher rate on the ramucirumab arm compared to the placebo arm were diarrhea and headache. "We are pleased with this data of ramucirumab used as monotherapy in a second-line setting in this difficult-to-treat disease. It reinforces our confidence in the ramucirumab development program, in which we currently have six Phase III studies ongoing in five tumor types – breast, colorectal, gastric, hepatocellular and lung cancer," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology. REGARD is one of two ramucirumab Phase III studies in gastric cancer. RAINBOW, a Phase III trial of ramucirumab in combination with paclitaxel, completed patient enrollment last month. Lilly plans to present data from the REGARD trial at an upcoming scientific meeting and will discuss submission plans with regulatory authorities.