Ramucirumab: Phase III data
Top-line data from the double-blind, international Phase III REGARD trial in 355 patients with metastatic gastric or gastroesophageal junction adenocarcinoma following disease progression on first-line platinum or fluoropyrimidine-containing combination therapy showed that 8 mg/kg IV ramucirumab every 2 weeks plus best supportive care (BSC) met the primary endpoint of OS vs. placebo plus BSC. Ramucirumab plus BSC also met the secondary endpoint of PFS vs. placebo plus BSC. The most common adverse events reported in the ramucirumab arm vs. placebo arm were hypertension, diarrhea and headache. BSC included anti-emetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors. Eli Lilly plans to present the REGARD data at an upcoming scientific meeting and will discuss submission plans with regulatory authorities. ...