| Abstract: |
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. © 2024 by American Society of Clinical Oncology. |
| Keywords: |
controlled study; protein expression; aged; aged, 80 and over; disease-free survival; middle aged; major clinical study; overall survival; clinical trial; mortality; cancer recurrence; cisplatin; placebo; cancer risk; adjuvant therapy; cancer adjuvant therapy; disease free survival; chemotherapy, adjuvant; cancer staging; follow up; metabolism; progression free survival; neoplasm recurrence, local; randomized controlled trial; pathology; bladder tumor; urinary bladder neoplasms; health care quality; tumor recurrence; adjuvant chemotherapy; neoplasm invasiveness; phase 3 clinical trial; drug therapy; carcinoma, transitional cell; double blind procedure; double-blind method; transitional cell carcinoma; recurrence free survival; programmed death 1 ligand 1; muscle invasive bladder cancer; tumor invasion; radical resection; distant metastasis free survival; nivolumab; very elderly; intention to treat analysis; humans; human; male; female; article; immunological antineoplastic agent; antineoplastic agents, immunological; b7-h1 antigen
|
