Pharmaceutical Business review

Eli Lilly REGARD trial meets primary endpoint

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.