A subgroup analysis of the East Asia population in RANGE: A randomized phase 3 study of docetaxel (DOC) with or without ramucirumab (RAM) in platinum-refractory advanced or metastatic urothelial carcinoma (UC)

Background: RANGE (NCT02426125) is a global, randomized, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of RAM in combination with DOC in patients (pts) with platinum-refractory advanced or metastatic UC. Here we report the results of RAM in combination with DOC in the East Asia population (EA). Methods: 530 pts were randomized (1:1) to DOC with either RAM 10 mg/kg or placebo (PL) on day 1 of a 21-day cycle (RAM/DOC or PL/DOC). EA pts (n = 110) received DOC 60 2; other pts received DOC 75 2. Primary endpoint was investigator-assessed progression free survival (PFS). Secondary endpoints included objective response rate (ORR), overall survival, safety, quality of life (QOL), and pharmacokinetics (PK). Results: PFS outcomes (investigator-assessed and blinded centrally reviewed) among EA remained consistent with the intention-totreat population (ITT) (Table). Improvements in ORR and 6/12 month PFS rates for EA were in line with those for ITT. The most common grade ≥3 adverse events in EA, neutropenia and leukopenia, were observed at a similar frequency in both arms. Mean scores for global QOL in EA stayed largely stable over time without a clear difference between arms. Plasma concentrations of DOC for pts in the 60 2group were similar to those for pts in the 75 2group. Conclusions: The DOC PK profile for EA pts receiving 60 2was consistent with non-EA pts receiving 75 2. Results in EA were consistent with the improved clinical outcomes and manageable safety profile observed with RAM/DOC in ITT.