270O - Nivolumab (NIVO) plus gemcitabine-cisplatin (GC) vs GC alone in Asian patients with previously untreated unresectable or metastatic urothelial carcinoma (u/mUC) from CheckMate 901

Background

The global phase III CheckMate 901 trial demonstrated overall survival (OS) and progression-free survival (PFS) benefit of NIVO + GC vs GC alone as first-line treatment for u/mUC. In Asia, the proportion of upper urinary tract urothelial carcinoma (UTUC) in UC is higher than that in the rest of the world. Here, we report the results of an Asian population analysis of CheckMate 901, including outcomes by tumor origins.

Methods

Patients (pts) with histologically confirmed u/mUC were randomized to receive either NIVO + GC followed by NIVO (for up to 2 years) or GC alone. The primary endpoints were OS and PFS. Objective response rate (ORR) and safety were key exploratory endpoints. Efficacy (ORR, OS, and PFS) by tumor origin (UTUC and bladder cancer [BC]) at diagnosis was also assessed.

Results

A total of 133 Asian pts were randomized (72 to NIVO + GC; 61 to GC). With a median follow-up of 27.2 months (mo), the median OS with NIVO + GC vs GC was 24.0 vs 18.9 mo (HR, 0.69; 95% CI, 0.42–1.15) and the median PFS was 9.5 vs 7.2 mo (HR, 0.53; 95% CI, 0.32–0.88). The ORR and the complete response rate were 58.3% and 20.8% with NIVO + GC, respectively, and were 39.3% and 9.8% with GC, respectively. There were no apparent differences in the efficacy results (the ORR and HRs for PFS and OS) between the UTUC and BC subgroups. The median duration of response (95% CI) was 9.5 (5.8–31.5) vs 6.1 (5.2–7.5) mo in NIVO + GC vs GC. The incidence of grade ≥3 treatment-related adverse events was 63.8% with NIVO + GC and 61.5% with GC. Table: 270O

BICR, blinded independent central review

Conclusions

Consistent with the findings in the global population, NIVO + GC showed a trend toward improved OS and PFS vs GC alone as first-line treatment in the Asian population. Furthermore, there were no apparent differences in the efficacy results between the UTUC and BC subgroups. These results support NIVO + GC as a new treatment option for Asian pts with u/mUC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Ono Pharmaceutical Co., Ltd.

Funding

Bristol Myers Squibb and Ono Pharmaceutical.

Disclosure

Y. Tomita: Financial Interests, Institutional, Research Funding: Ono Pharmaceutical, Bristol Myers Squibb; Financial Interests, Personal, Speaker’s Bureau: Ono Pharmaceutical, Bristol Myers Squibb, Merck Sharp & Dohme; Financial Interests, Personal, Advisory Role: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board: Eisai. A. Fujii: Financial Interests, Institutional, Full or part-time Employment: Ono Pharma. N. Takeuchi: Financial Interests, Institutional, Full or part-time Employment: Ono Pharmaceutical Co., Ltd. All other authors have declared no conflicts of interest.