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. DFS improvement with NIVO was generally consistent across subgroups. 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.
CHECKMATE 274 TRIAL
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. 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. There were two deaths due to pneumonitis and one death due to bowel perforation in the nivolumab group, and all three deaths were considered related to treatment.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. Grade 3 or higher adverse events occurred in 17.9% of patients receiving nivolumab and 7.2% of patients receiving the placebo. Conclusions: In this trial involving patients with high-risk muscle-invasive urothelial carcinoma who had undergone radical surgery, disease-free survival was longer with adjuvant nivolumab than with placebo in the intention-to-treat population and among patients with a PD-L1 expression level of 1 or more. In addition, 75.3% of patients treated with nivolumab did not have recurrence outside of the urothelial tract at 6 months, compared with 56.7% of those treated with the placebo (hazard ratio = 0.55).
CHECKMATE 274 FREE
Among those with an expression of 1% of more, 74.5% of the nivolumab group was disease free and alive at 6 months, compared with 55.7% of the placebo group (hazard ratio = 0.55). Patients were tested for PD-L1 expression. In addition, patients in the nivolumab group had a median survival free from recurrence outside of the urothelial tract of 22.9 months, compared with 13.7 months in the placebo group. After 6 months of therapy, the percentage of patients who were both alive and free of disease was 74.9% in the group receiving nivolumab treatment and 60.3% in the group receiving the placebo (hazard ratio for disease recurrence of death = 0.70, P <. The median disease-free survival among the intention-to-treat population was 20.8 months in the nivolumab group, compared with 10.8 months in the placebo group. Patients who had undergone neoadjuvant chemotherapy with cisplatin were allowed to enroll as well. Patients underwent radical surgery and were randomly assigned 1:1 to receive 240 mg of intravenous nivolumab or placebo every 2 weeks for up to 1 year. This double-blind, randomized, controlled trial enrolled 709 patients with muscle-invasive urothelial carcinoma. Galsky, MD, of Icahn School of Medicine at Mount Sinai, New York and colleagues published their findings from the phase III multicenter CheckMate 274 trial in The New England Journal of Medicine. CheckMate 274: Adjuvant Nivolumab in Muscle-Invasive Urothelial Carcinomaīy: Lauren Harrison, MS Posted: Monday, September 27, 2021Īmong patients with muscle-invasive urothelial carcinoma who undergo radical surgery and are treated with adjuvant nivolumab, disease-free survival was found to be longer when compared with those treated with placebo.
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