Lilly Announces Ramucirumab Improves OS, PFS in Metastatic Gastric Cancer

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(ChemotherapyAdvisor) – Ramucirumab improves survival times as a second-line single-agent therapy for patients with metastatic gastric cancer, according to results from the Phase 3, placebo-controlled REGARD trial, Lilly Oncology announced Oct. 15.

The REGARD trial compared ramucirumab monotherapy with placebo as a second-line therapy for patients with metastatic gastric tumors and gastroesophageal junction tumors. Both study end-points, improved PFS (progression-free survival) and OS (overall survival), were met among ramucirumab-arm patients, according to the company's announcement. Detailed statistical analyses were not immediately available.

“We are pleased with this data of ramucirumab used as a monotherapy in a second-line setting in this difficult-to-treat disease,” said Richard Gaynor, MD, vice president for product development and medical affairs at Lilly Oncology. “It reinforces our confidence in the ramucirumab development program, in which we currently have six Phase 3 studies ongoing in five tumor types – breast, colorectal, gastric, hepatocellular and lung cancer.”

Hypertension (any grade) was the most frequent adverse event among ramucirumab-arm patients; diarrhea and headache were also associated with ramucirumab, occurring in more than 5% of patients.

According to the company's announcement, REGARD is 1 of 2 ramucirumab Phase 3 trials under way for gastric cancers; RAINBOW, a Phase 3 trial of ramucirumab plus paclitaxel, completed patient enrollment last month.

Ramucirumab is a human IgG1 monoclonal antibody receptor antagonist that binds to the extracellular domain of VEGF (vascular endothelial growth factor)-receptor 2, preventing VEGF-A, VEGF-C and VEGF-D ligands from activating receptors involved in angiogenesis. VEGF-receptor 2 is important in endothelial cell proliferation, survival, migration and blood vessel permeability.

Separately, an interim analysis of a Phase 2 trial separately suggested that adding ramucirumab to first-line platinum chemotherapy for non-small cell lung cancer (NSCLC) might improve progression-free survival (PFS) with tolerable toxicities.

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