Characterization of Patients with Lymph Node Only Metastatic Urothelial Carcinoma Treated with Nivolumab Plus Gemcitabine-Cisplatin Versus Gemcitabine-Cisplatin Alone from the CheckMate 901 Trial

Nivolumab (NIVO) plus gemcitabine-cisplatin (GC) demonstrated deep, durable responses in patients with untreated unresectable or metastatic urothelial carcinoma (mUC) with superior overall (OS) and progression-free (PFS) survival versus GC alone. We report post hoc exploratory analyses with 33.6 mo of median follow-up in patients with lymph node (LN) only disease from CheckMate 901. In this phase 3 randomized trial (n = 608), cisplatin-eligible patients received NIVO 360 mg plus GC every 3 wk (Q3W) for six or fewer cycles followed by NIVO 480 mg every 4 wk for ≤2 yr, or GC Q3W for six or fewer cycles. The primary endpoints were OS and PFS by a blinded independent central review (BICR). The objective response rate (ORR) as per the BICR and safety were exploratory. This post hoc analysis evaluated patients with LN only mUC (n = 110). In this subgroup, OS (hazard ratio [HR], 0.58; 95% confidence interval [CI] 0.34-1.00) and PFS (HR, 0.38; 95% CI 0.22-0.66) improved with NIVO + GC versus GC. The ORR was 81% with NIVO + GC versus 64% with GC; complete response rates were 63% versus 34%. The incidence of treatment-related adverse events was similar between arms. In conclusion, clinically meaningful improvements in OS, PFS, and ORR, including twice the rate of complete response and more patients with treatment-free intervals, were observed with NIVO + GC versus GC in patients with LN only disease, providing additional support for first-line NIVO plus cisplatin-based chemotherapy in mUC.

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Publication Details

Journal
European Urology
Published
2025-05-20
DOI
https://doi.org/10.1016/j.eururo.2025.04.019
Citations
6
Primary Topic
Bladder and Urothelial Cancer Treatments
Type
article
Field-Weighted Citation Impact
12.04

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article

Characterization of Patients with Lymph Node Only Metastatic Urothelial Carcinoma Treated with Nivolumab Plus Gemcitabine-Cisplatin Versus Gemcitabine-Cisplatin Alone from the CheckMate 901 Trial

Yoshihiko Tomita, Matthew D. Galsky, Lily Wang, Maximiliano van Kooten Losio et al.
6 citations
European Urology
Bladder and Urothelial Cancer Treatments
12.04
article

Characterization of Patients with Lymph Node Only Metastatic Urothelial Carcinoma Treated with Nivolumab Plus Gemcitabine-Cisplatin Versus Gemcitabine-Cisplatin Alone from the CheckMate 901 Trial

Yoshihiko Tomita, Matthew D. Galsky, Lily Wang, Maximiliano van Kooten Losio, Philippe Beuzeboc, Michael Schenker, Michiel S. van der Heijden, Mélanie Claps, Aristotelis Bamias, Begoña P. Valderrama, Juan Pablo Sade, Guru Sonpavde, Yüksel Ürün, Mauricio Burotto, Jens Bedke, Jeiry Filian, Thomas B. Powles, Dingwei Ye, Jan Oldenburg, Ruiyun Jiang
article en
6 citations

Abstract

Nivolumab (NIVO) plus gemcitabine-cisplatin (GC) demonstrated deep, durable responses in patients with untreated unresectable or metastatic urothelial carcinoma (mUC) with superior overall (OS) and progression-free (PFS) survival versus GC alone. We report post hoc exploratory analyses with 33.6 mo of median follow-up in patients with lymph node (LN) only disease from CheckMate 901. In this phase 3 randomized trial (n = 608), cisplatin-eligible patients received NIVO 360 mg plus GC every 3 wk (Q3W) for six or fewer cycles followed by NIVO 480 mg every 4 wk for ≤2 yr, or GC Q3W for six or fewer cycles. The primary endpoints were OS and PFS by a blinded independent central review (BICR). The objective response rate (ORR) as per the BICR and safety were exploratory. This post hoc analysis evaluated patients with LN only mUC (n = 110). In this subgroup, OS (hazard ratio [HR], 0.58; 95% confidence interval [CI] 0.34-1.00) and PFS (HR, 0.38; 95% CI 0.22-0.66) improved with NIVO + GC versus GC. The ORR was 81% with NIVO + GC versus 64% with GC; complete response rates were 63% versus 34%. The incidence of treatment-related adverse events was similar between arms. In conclusion, clinically meaningful improvements in OS, PFS, and ORR, including twice the rate of complete response and more patients with treatment-free intervals, were observed with NIVO + GC versus GC in patients with LN only disease, providing additional support for first-line NIVO plus cisplatin-based chemotherapy in mUC.

European UrologyVol. 88(4)
Harvard University (US), Ankara University (TR), Queen Mary University of London (GB), National and Kapodistrian University of Athens (GR), Akershus University Hospital (NO), University of Medicine and Pharmacy of Craiova (RO), The Netherlands Cancer Institute (NL), Bristol-Myers Squibb (United States) (US), Fudan University Shanghai Cancer Center (CN), Oncode Institute (NL), Dana-Farber Cancer Institute (US), Instituto Alexander Fleming (AR), Tisch Hospital (US), Hospital Universitario Virgen del Rocío (ES), Fondazione IRCCS Istituto Nazionale dei Tumori (IT), Hôpital Foch (FR), Niigata University (JP), University of Tübingen (DE), Icahn School of Medicine at Mount Sinai (US)
Bristol-Myers Squibb
Good health and well-being
Openalex Percentile: Top 1%
Bladder and Urothelial Cancer Treatments
12.04
DOIOpen Access PDFOpenAlex
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