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 JCO or elsewhere, for which the primary end point has already been reported.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 oncology : official journal of the American Society of Clinical Oncology. 2024 Oct 11 [Epub ahead of print]
Matthew D Galsky, Johannes Alfred Witjes, Jürgen E Gschwend, Matthew I Milowsky, Michael Schenker, Begoña P Valderrama, Yoshihiko Tomita, Aristotelis Bamias, Thierry Lebret, Shahrokh F Shariat, Se Hoon Park, Mads Agerbaek, Gautam Jha, Frank Stenner, Dingwei Ye, Fabio Giudici, Santanu Dutta, Margarita Askelson, Federico Nasroulah, Joshua Zhang, Lynne Brophy, Dean F Bajorin
Icahn School of Medicine at Mount Sinai, New York, NY., Radboud University, Nijmegen, the Netherlands., Technical University Munich, Munich, Germany., University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC., Sf. Nectarie Oncology Center, Craiova, Romania., Hospital Universitario Virgen del Rocío, Sevilla, Spain., Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan., National and Kapodistrian University of Athens, Athens, Greece., Hôpital Foch, Paris-Saclay University UVSQ, Versailles, France., Medical University of Vienna, Vienna General Hospital, Vienna, Austria., Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea., Aarhus University Hospital, Aarhus, Denmark., M Health Fairview Clinics and Surgery Center, Minneapolis, MN., University Hospital Basel, Basel, Switzerland., Fudan University Shanghai Cancer Center, Shanghai, China., Bristol Myers Squibb, Princeton, NJ., Memorial Sloan Kettering Cancer Center, New York, NY.