dThere were 2 deaths due to pneumonitis in the NIVO arm. Research Sponsor: Bristol Myers SquibbĪ98.31% CI. These results support adjuvant NIVO as a new SOC for pts with MIUC with high risk for recurrence despite neoadjuvant chemo or those ineligible for and/or declining cisplatin-based chemo. AEs were manageable and consistent with previous reports. Conclusions: NIVO demonstrated a statistically significant and clinically meaningful improvement in DFS vs PBO for MIUC after radical surgery, both in ITT pts and pts with PD-L1 ≥ 1%. Grade 3–4 treatment-related adverse events (TRAEs) occurred in 17.9% and 7.2% of pts in the NIVO and PBO arms, respectively. About 700 patients participated in the phase III, randomized, double-blind CheckMate 274 trial half were given nivolumab and the other half placebo after having surgery with chemotherapy beforehand. DFS improvement with NIVO was generally consistent across subgroups. The results support giving adjuvant nivolumab as the standard of care for patients who have muscle-invasive urothelial carcinoma. DFS and NUTRFS were improved with NIVO vs PBO in both populations (Table). The primary endpoint of DFS was met in ITT pts (median follow-up, 20.9 mo for NIVO 19.5 mo for PBO) and in pts with PD-L1 ≥ 1%. Results: In total, 353 pts were randomized to NIVO (PD-L1 ≥ 1%, n = 140) and 356 pts to PBO (PD-L1 ≥ 1%, n = 142). Non–urothelial tract recurrence-free survival (NUTRFS) in ITT pts and in pts with PD-L ≥ 1% is a secondary endpoint. DFS was stratified by nodal status, prior neoadjuvant cisplatin, and PD-L1 status. Primary endpoints: disease-free survival (DFS) in all randomized pts (ITT population) and in pts with tumor PD-L1 expression ≥ 1%. Pts had radical surgery within 120 days ± neoadjuvant cisplatin or were ineligible/declined cisplatin-based chemo, evidence of UC at high risk of recurrence per pathologic staging, were disease-free by imaging, and ECOG PS ≤ 1. Pts were randomized 1:1 to NIVO 240 mg Q2W or PBO for ≤ 1 year of adjuvant treatment. Methods: This is a phase 3, randomized, double-blind, multicenter trial of NIVO vs PBO in pts with high-risk MIUC (bladder, ureter, or renal pelvis) after radical surgery. ![]() This phase 3 trial of adjuvant nivolumab (NIVO) vs placebo (PBO) in pts with MIUC after radical surgery ± neoadjuvant cisplatin (CheckMate 274) aims to address an unmet need in these pts. This post hoc analysis assessed the impact of recurrence on HRQoL using data from the phase 3 CheckMate 274 trial. ![]() Recurrence is associated with worse survival, but its effect on health-related quality of life (HRQoL) is unclear. There is no conclusive evidence supporting adjuvant chemo in pts who did not receive neoadjuvant chemo and in those with residual disease after neoadjuvant cisplatin. 4540 Background: Patients (pts) undergoing radical surgery for MIUC face a high risk of disease recurrence. Background: The standard of care (SOC) for patients (pts) with MIUC is radical surgery ± cisplatin-based neoadjuvant chemotherapy (chemo), but many pts are cisplatin-ineligible.
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