Cyramza fails to improve overall survival in gastric cancer, Lilly scraps regulatory plans
pharmafile | December 11, 2017 | News story | Research and Development, Sales and Marketing | Cancer, Eli Lilly, cyramza, gastric cancer, pharma
Eli Lilly has unveiled Phase 3 results which reveal that its VEGF Receptor 2 antagonist Cyramza (ramucirumab) met its primary endpoint of progression-free survival (PFS) when used in combination with cisplatin and capecitabine or 5-FU (5-fluorouracil) as a first-line treatment of patients with HER2-negative metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. However, despite this, the treatment failed to improve overall survival (OS), and as a result Lilly will not be looking to file for regulatory approval in this indication.
Cyramza was tested in a 645-participant clinical trial, each of whom had either metastatic gastric cancer or gastroesophageal junction adenocarcinoma; patients unable to take capecitabine were given 5-fluorouracil. Full results of the study are due to be presented at a future medical meeting.
“While we hoped that the positive PFS outcome would have translated into an OS benefit, these […] results highlight the challenges associated with improving outcomes for people with advanced gastric cancer,” commented Levi Garraway, Senior Vice President of 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.”
“Lilly is deeply committed to patients with this aggressive disease, and Cyramza remains a standard of care in the second-line treatment paradigm for advanced gastric cancer patients around the world,” he added. “We thank the patients, their caregivers and investigators for their support of and participation in the Rainfall study.”
Matt Fellows
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