Eli Lilly’s Cyramza has hit its primary goal in a late-stage study showing extended progression-free survival in patients with gastric cancer, but the drug failed to improve overall survival, a secondary endpoint.
The Phase III RAINFALL study assessed Cyramza (ramucirumab) in combination with cisplatin and capecitabine or 5-FU (5-fluorouracil) in the first-line treatment of patients with HER2-negative metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
"While we hoped that the positive PFS outcome would have translated into an OS benefit, these RAINFALL results highlight the challenges associated with improving outcomes for people with advanced gastric cancer," said Levi Garraway, senior vice president, global development and medical affairs, Lilly Oncology.
"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."
Cyramza is cleared as a second-line treatment for advanced gastric cancer patients around the world. Based on data from the RAINFALL study, Lilly will not be pursuing the drug’s approval in the first-line setting.
Cyramza is being assessed in what the firm describes as a “broad global development programme” involving more than 10,000 patients across more than 70 trials worldwide, both as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumor types.