Phase III RANGE trial of Cyramza shows positive trend in advanced urothelial carcinoma.- Eli Lilly.
Eli Lilly announced additional results from its global, randomized, double-blind, placebo-controlled Phase III RANGE trial evaluating Cyramza (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. A positive trend was seen in the secondary endpoint of overall survival (OS) which did not reach statistical significance. An improvement in objective response rate (ORR) was observed.
Lilly previously announced that the trial met its primary endpoint of investigator-assessed progression-free survival (PFS); those results were presented at the European Society for Medical Oncology (ESMO) 2017 Congress and simultaneously published in The Lancet. RANGE is the only Phase III study to demonstrate superior PFS compared to chemotherapy in a post-platinum setting in advanced urothelial carcinoma. Additionally, RANGE is the first Phase III trial to show the benefit of targeting angiogenesis in urothelial carcinoma.
No new safety signals were observed. The safety profile observed in the RANGE study was consistent with what was seen previously in this trial and what has been previously observed for Cyramza. The efficacy and safety results will be submitted for presentation at a future medical meeting.
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