12 september, 2017
Ramucirumab plus docetaxel improves progression-free survival in patients with advanced or metastatic urothelial cancer who have progressed on platinum-based chemotherapy, according to late-breaking results from the phase III RANGE trial presented at the ESMO 2017 Congress in Madrid to be published in The Lancet.
Checkpoint inhibitors are effective in about 25% of patients with platinum-refractory advanced or metastatic urothelial cancer, but there are few options for those who progress or are ineligible. A phase II study found that adding the vascular endothelial growth factor receptor 2 (VEGFR-2) antibody ramucirumab to docetaxel nearly doubled progression-free survival compared to docetaxel alone in patients with platinum-refractory advanced or metastatic urothelial cancer (3).
The findings provided the rationale for the phase III RANGE trial presented today. The trial included 530 patients with advanced or metastatic urothelial cancer who had progressed on first line platinum-based chemotherapy within the previous 14 months. Patients were randomised 1:1 to ramucirumab plus docetaxel (263 patients) versus placebo plus docetaxel (267 patients).
The primary endpoint of investigator-assessed progression-free survival was significantly prolonged with ramucirumab plus docetaxel compared to placebo plus docetaxel (4.07 months versus 2.76 months; hazard ratio, 0.757). Results were slightly more favourable in a blinded central analysis, with a progression-free survival of 4.04 months with ramucirumab/docetaxel compared to 2.46 months with placebo/docetaxel (hazard ratio, 0.672).
ESMO 2017 Press Release: Ramucirumab plus Docetaxel Improves Progression-free survival in Urothelial Cancer