Results From Phase III RANGE Study of Ramucirumab in Advanced or Metastatic Urothelial Cancer
Eli Lilly and Company recently announced additional results from its global, randomized, double-blind, placebo-controlled phase III RANGE trial evaluating ramucirumab (Cyramza) in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy.
Top-Line Results
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 by Petrylak et al 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, and 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 ramucirumab. The efficacy and safety results will be submitted for presentation at a future medical meeting.
“People with advanced urothelial carcinoma who experience disease progression urgently need treatment options that can control the disease—to help stop or slow the cancer from growing and spreading,” said Levi Garraway, MD, PhD, Senior Vice President, Global Development and Medical Affairs, Lilly Oncology. “Although this study didn't reach statistical significance for overall survival, we are encouraged by the totality of the RANGE results and look forward to reviewing the data with internal and external experts to determine next steps.”
More About the RANGE Study
The RANGE trial, which enrolled 530 patients globally, is a randomized, double-blind study designed to evaluate the safety and efficacy of ramucirumab and docetaxel vs placebo and docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. The trial includes patients whose disease progressed following adjuvant and/or neoadjuvant therapy; patients whose disease progressed following first-line therapy for metastatic disease; and patients who had received prior platinum-based and immune checkpoint inhibitor regimens.
The trial's primary endpoint is investigator-assessed progression-free survival, and secondary endpoints include overall survival, objective response rate, disease control rate, and patient-reported outcomes.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
