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news.Eli Lilly and Company reported that the REGARD trial evaluating ramucirumab (IMC-1121B) in patients with metastatic gastric cancer has met its primary endpoint of improved overall survival and demonstrated prolonged progression-free survival.
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The REGARD trial, one of the two ramucirumab Phase III studies in gastric cancer, compared ramucirumab and best supportive care with placebo and best supportive care as a second-line treatment in metastatic gastric and gastroesophageal junction cancer patients.
Lilly Oncology product development and medical affairs vice president Richard Gaynor said the data of ramucirumab used as monotherapy in a second-line setting in the disease is encouraging.
"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," Gaynor added.
Hypertension was the most frequent adverse reaction occurring at a higher rate on the ramucirumab arm while diarrhea and headache are the other adverse reactions occurring at a higher rate on the ramucirumab arm compared to the placebo arm.
The second Phase III trial of ramucirumab compared with paclitaxel, the RAINBOW trial, finished enrolling patients.