Nivolumab plus gemcitabine-cisplatin for previously untreated unresectable or metastatic urothelial carcinoma: an Asian subgroup analysis from the global phase 3 CheckMate 901 trial.

Abstract

Background: In the global phase 3 CheckMate 901 trial, nivolumab plus gemcitabine-cisplatin demonstrated significantly improved overall survival (OS) and progression-free survival (PFS) for unresectable or metastatic urothelial carcinoma (UC). However, clinical benefit for patients from Asian countries remains unclear. Here, we analyzed outcomes in the Asian population from CheckMate 901.

Methods: Patients with unresectable or metastatic UC were randomized to receive nivolumab plus gemcitabine-cisplatin or gemcitabine-cisplatin alone. Efficacy including OS and PFS and safety were evaluated in the Asian population.

Results: A total of 133 patients (72 received nivolumab plus gemcitabine-cisplatin, and 61 received gemcitabine-cisplatin alone) were enrolled from China, Japan, South Korea, Taiwan, and Singapore between January 2018 and September 2022. The median follow-up was 27.2 months. OS and PFS favored nivolumab plus gemcitabine-cisplatin over gemcitabine-cisplatin alone (median OS, 24.0 vs. 18.9 months; median PFS, 9.5 vs. 7.2 months) with hazard ratios of 0.69 for OS and 0.53 for PFS. Similar trends towards favorable OS and PFS was found in subgroups with tumor PD-L1 expression ≥1%, and regardless of tumor origin (bladder cancer or upper tract UC). The incidence of grade ≥3 treatment-related adverse events was 63.9% with nivolumab plus gemcitabine-cisplatin and 61.4% with gemcitabine-cisplatin alone.

Conclusions: Nivolumab plus gemcitabine-cisplatin showed a trend towards improved OS and PFS outcomes in the Asian population, suggesting that the combination therapy may serve as a new treatment option for patients from Asian countries who have unresectable or metastatic UC.

Trial registration: ClinicalTrials.gov, NCT03036098.