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Ramucirumab meets survival endpoints for gastric, not breast cancer
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Ramucirumab met its endpoints of overall and progression-free survival in a phase 3 study of its use in gastric cancer, but not in a separate study for metastatic breast cancer, according to a press release.
Results from the global, double blind, randomized RAINBOW trial indicated that ramucirumab (Eli Lilly) administered in combination with paclitaxel to patients with locally advanced, unresectable or metastatic gastric cancer improved overall and progression-free survival compared with paclitaxel alone. All patients had cancer that had progressed or was refractory after initial chemotherapy.
Abdominal pain, fatigue, hypertension, leucopenia and neutropenia were the most frequent adverse events of grade 3 or higher and were more common among ramucirumab recipients than those treated with paclitaxel alone. These results followed the REGARD study, in which ramucirumab monotherapy improved overall and progression-free survival in this population.
“We are excited to see a second positive phase 3 trial of ramucirumab in gastric cancer demonstrating an improvement in both overall survival and progression free survival, as stomach cancer is a difficult-to-treat disease that remains a major health problem worldwide,” Richard Gaynor, MD, vice president of product development and medical affairs for Lilly Oncology, said in the release.
In a separate, double blind, randomized phase 3 study, ramucirumab administered as a first-line therapy in combination with docetaxel did not significantly improve progression-free survival in women with metastatic or locally recurrent breast cancer, compared with docetaxel alone. Interim analysis also indicated no overall survival benefit among ramucirumab recipients. Commonly observed adverse events included fatigue, hypertension, neutropenia and stomatitis, which occurred more frequently in the ramucirumab group.
“We are disappointed that this breast cancer trial did not meet its primary endpoint,” Gaynor said. “However, now with two positive gastric cancer trials, Lilly remains confident in the overall ramucirumab development program.” Additional trials evaluating the drug as treatment for colorectal, hepatocellular and lung cancers are anticipated in 2014.