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Lilly’s cyramza succeeds in phase 3 urothelial cancer trial

PBR Staff Writer Published 01 June 2017

Eli Lilly's Cyramza (ramucirumab), in combination with docetaxel, has succeeded in a phase 3 urothelial cancer trial by meeting its primary endpoint of significantly improving progression-free survival (PFS).

The Range phase 3 trial evaluated the safety and efficacy of the combination of ramucirumab and docetaxel against placebo and docetaxel in a randomized, double-blinded setting.

It featured 531 previously treated patients with locally advanced or unresectable or metastatic urothelial carcinoma.

Ramucirumab is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist. It precisely binds and prevents VEGF Receptor 2 from getting activated by blocking the binding of certain VEGF receptor ligands.

Based on the results recorded in the study, Lilly stated that it is the first phase 3 trial of any therapy for urothelial cancer to have scored superior PFS over chemotherapy in a post-platinum setting.

It also added that ramucirumab is the first antiangiogenic agent to extend PFS in any urothelial cancer phase 3 study.

Lilly Oncology global development and medical affairs senior vice president Levi Garraway said: "People with advanced urothelial cancer - an aggressive disease - who have progressed on prior therapy need more treatment options that can help to control their disease.

"Until now, no Phase 3 study has demonstrated superior PFS over chemotherapy in this setting. These results are encouraging and we look forward to seeing the overall survival results when they are mature.”

Lilly said that it would wait for the overall survival (OS) results for the ramucirumab and docetaxel combination before applying for regulatory approvals as therapy for urothelial carcinoma. The results for the final OS are expected to be ready by mid-2018.

Image: Eli Lilly and Company's global headquarters, in Indianapolis, Indiana, US. Photo: courtesy of Guanaco152003.