Eli Lilly says Phase 3 RANGE study didn't reach statistical significance for OS
Eli Lilly announced additional results from its global, randomized, double-blind, placebo-controlled Phase 3 RANGE trial evaluating 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. A positive trend was seen in the secondary endpoint of overall survival, or OS, which did not reach statistical significance. An improvement in objective response rate was observed. Lilly previously announced that the trial met its primary endpoint of investigator-assessed progression-free survival; those results were presented at the European Society for Medical Oncology 2017 Congress and simultaneously published in The Lancet. Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology, said, "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." Lilly said it remains committed to the investigation and use of CYRAMZA in other tumor types, including those in which it has already demonstrated a Phase 3 overall survival benefit - stomach, non-small cell lung, colorectal and liver cancer.