Eli Lilly and Co.'s phase 3 trial of a Cyramza and chemotherapy combination to treat gastric cancer met its main goal of extending life without the disease getting worse.
However, the treatment failed its secondary goal of improving overall survival.
The trial evaluated Cyramza, or ramucirumab, in combination with chemotherapy medicines cisplatin and capecitabine, or 5-fluorouracil, as a first-line treatment for patients with HER2-negative metastatic gastric or gastroesophageal junction adenocarcinoma.
Lilly said it will not seek regulatory approval based on the results of this phase 3 RAINFALL trial. It also stated that the outcome of this study does not have any impact on current Cyramza approvals.
Levi Garraway, senior vice president of global development and medical affairs for Lilly Oncology, said the company hoped the positive progression-free survival outcome would have translated into an overall survival benefit but the results "highlight the challenges associated with improving outcomes for people with advanced gastric cancer."
"This is underscored by the fact that there have been no major advances over standard chemotherapy in the first-line HER2-negative gastric cancer treatment setting in the last decade," said Garraway.
In September, Lilly reported results from a phase 3 trial of Cyramza plus docetaxel, which showed improved progression-free survival in patients with urothelial cancer, a type of bladder cancer.
Cyramza was approved by the U.S. Food and Drug Administration in 2014 to treat patients with advanced gastric cancer after prior chemotherapy.