Phase III RANGE study of Cyramza (ramucirumab) met its primary endpoint in metastatic urothelial carcinoma- Eli Lilly

Eli Lilly announced that its Phase III RANGE study of Cyramza (ramucirumab) met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement in metastatic urothelial carcinoma. The Phase III global, randomized, double-blinded, placebo-controlled trial is evaluating ramucirumab in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy.

With these results, RANGE is the first Phase III study of any therapy to show superior PFS over chemotherapy in a post-platinum setting in urothelial cancer. Also, ramucirumab is the first antiangiogenic agent to extend PFS in a Phase III trial in urothelial cancer. Patients previously treated with a checkpoint inhibitor were allowed to enroll in the RANGE study. The safety profile observed in the RANGE study at this analysis was consistent with what has been previously observed for ramucirumab. Grades beyond 3 adverse events occurring at a rate of five percent or greater and that were higher on the ramucirumab-plus-docetaxel arm compared to the placebo-plus-docetaxel arm were neutropenia, febrile neutropenia and hypertension. Detailed efficacy and safety results will be submitted for presentation at a future medical meeting.

Comment: Bladder cancer accounts for the majority of all urothelial carcinoma.