Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma: Expanded Efficacy From CheckMate 274

<i>Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in</i> JCO <i>or elsewhere, for which the primary end point has already been reported</i>.CheckMate 274 is a phase III, randomized, double-blind trial of adjuvant nivolumab versus placebo for muscle-invasive urothelial carcinoma (MIUC) at high risk of recurrence after radical resection. The primary end points of disease-free survival (DFS) in intent-to-treat (ITT) and tumor PD-L1 expression ≥1% populations were met. We report results at an extended median follow-up of 36.1 months in the ITT population. In addition, we report interim overall survival (OS) data for the first time and an exploratory analysis among patients with bladder primary tumors (muscle-invasive bladder cancer [MIBC]). Consistent DFS benefit with nivolumab versus placebo was observed in both the ITT (hazard ratio [HR], 0.71 [95% CI, 0.58 to 0.86]) and PD-L1 ≥1% (HR, 0.52 [95% CI, 0.37 to 0.72]) patients. The HR for OS with nivolumab versus placebo was 0.76 (95% CI, 0.61 to 0.96) in the ITT population and 0.56 (95% CI, 0.36 to 0.86) in the PD-L1 ≥1 population. Continuous benefit in nonurothelial tract recurrence-free survival and distant metastasis-free survival was also observed in both patient populations. The exploratory analysis of patients with MIBC also showed continued efficacy benefits, irrespective of PD-L1 status. No new safety signals were reported. Overall, these results further support adjuvant nivolumab as a standard of care for high-risk MIUC after radical resection.

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Publication Details

Journal
Journal of Clinical Oncology
Published
2024-10-11
DOI
https://doi.org/10.1200/jco.24.00340
Citations
89
Primary Topic
Bladder and Urothelial Cancer Treatments
Type
article
Field-Weighted Citation Impact
50.98

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article

Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma: Expanded Efficacy From CheckMate 274

Yoshihiko Tomita, Lynne Brophy, Matthew D. Galsky, Santanu Dutta et al.
89 citations
Journal of Clinical Oncology
Bladder and Urothelial Cancer Treatments
50.98
article

Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma: Expanded Efficacy From CheckMate 274

Yoshihiko Tomita, Lynne Brophy, Matthew D. Galsky, Santanu Dutta, Thierry Lebrét, Michael Schenker, J. Alfred Witjes, Aristotelis Bamias, Begoña P. Valderrama, Federico Nasroulah, Mads Agerbæk, Se Hoon Park, Dean F. Bajorin, Jürgen E. Gschwend, Fabio Giudici, Margarita Askelson, Shahrokh François Shariat, Matthew I. Milowsky, Gautam Jha, Frank Stenner, Dingwei Ye, Joshua Zhang
article en
89 citations

Abstract

<i>Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in</i> JCO <i>or elsewhere, for which the primary end point has already been reported</i>.CheckMate 274 is a phase III, randomized, double-blind trial of adjuvant nivolumab versus placebo for muscle-invasive urothelial carcinoma (MIUC) at high risk of recurrence after radical resection. The primary end points of disease-free survival (DFS) in intent-to-treat (ITT) and tumor PD-L1 expression ≥1% populations were met. We report results at an extended median follow-up of 36.1 months in the ITT population. In addition, we report interim overall survival (OS) data for the first time and an exploratory analysis among patients with bladder primary tumors (muscle-invasive bladder cancer [MIBC]). Consistent DFS benefit with nivolumab versus placebo was observed in both the ITT (hazard ratio [HR], 0.71 [95% CI, 0.58 to 0.86]) and PD-L1 ≥1% (HR, 0.52 [95% CI, 0.37 to 0.72]) patients. The HR for OS with nivolumab versus placebo was 0.76 (95% CI, 0.61 to 0.96) in the ITT population and 0.56 (95% CI, 0.36 to 0.86) in the PD-L1 ≥1 population. Continuous benefit in nonurothelial tract recurrence-free survival and distant metastasis-free survival was also observed in both patient populations. The exploratory analysis of patients with MIBC also showed continued efficacy benefits, irrespective of PD-L1 status. No new safety signals were reported. Overall, these results further support adjuvant nivolumab as a standard of care for high-risk MIUC after radical resection.

Journal of Clinical OncologyVol. 43(1)
University of North Carolina at Chapel Hill (US), Fairview Health Services (US), Memorial Sloan Kettering Cancer Center (US), Radboud University Nijmegen (NL), Université de Versailles Saint-Quentin-en-Yvelines (FR), National and Kapodistrian University of Athens (GR), Université Paris-Saclay (FR), Samsung Medical Center (KR), Vienna General Hospital (AT), Aarhus University Hospital (DK), University Hospital of Basel (CH), Bristol-Myers Squibb (United States) (US), Fudan University Shanghai Cancer Center (CN), Hospital Universitario Virgen del Rocío (ES), Hôpital Foch (FR), UNC Lineberger Comprehensive Cancer Center, Niigata University (JP), Medical University of Vienna (AT), Sungkyunkwan University (KR), Icahn School of Medicine at Mount Sinai (US)
Bristol-Myers Squibb, Ono Pharmaceutical
Good health and well-being
Openalex Percentile: Top 0%
Bladder and Urothelial Cancer Treatments
50.98
DOIOpen Access PDFOpenAlex
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