In the subgroup analysis, improved DFS was observed with nivolumab, compared with placebo, for those in subgroups including age (<65: HR, 0.73 95% CI, 0.53-1.01), sex (female: HR, 0.77, 95% CI, 0.50-1.17), ECOG performance status (1: HR, 0.79 95% CI, 0.56-1.12), nodal status (N0/x with <10 nodes removed: HR, 0.85 95% CI, 0.57-1.27), use of prior cisplatin-based chemotherapy (No: HR, 0.90 95% CI, 0.68-1.18), and PD-L1 status (<1%: HR, 0.82 95% CI, 0.63-1.05).Īt 12 months, NUTRFS probabilities were also improved with nivolumab, vs placebo, in both the ITT (65.8% vs 50.6%, respectively) and PD-L1 expression of 1% or greater (69.2% vs 47.1%) populations. DFS probability at 12 months was 63.5% with nivolumab and 46.9% with placebo in ITT patients, and 67.6% vs 46.3%, respectively, among patients with PD-L1 expression of 1% or greater. With the longer follow-up, the anti–PD-1 antibody demonstrated improved DFS, compared with placebo, in the ITT nivolumab and placebo groups (22.0 months vs 10.9 months, respectively), as well as in the PD-L1 of 1% or greater groups (not reached vs 8.4 months TABLE 11 ). The safety profile of nivolumab was consistent with that observed in previous trials.įollowing an additional follow-up of 5 months, which included a minimum follow-up in the intent-to-treat (ITT) population of 11 months (median follow-up in the nivolumab vs placebo group, 24.4 months vs 22.5 months, respectively) and 11.4 months in the PD-L1 of 1% or greater group (median follow-up in the nivolumab vs placebo group, 25.5 months vs 22.4 months), DFS benefit with nivolumab was maintained.
001) and in the population with tumor PD-L1 expression of 1% or greater (HR, 0.55 98.72% CI, 0.35-0.85 P<. They also were required to have an ECOG performance status of 0 or 1.įollowing a previous minimum follow-up in the ITT population of 5.9 months, DFS was significantly improved with nivolumab, compared with placebo, both in the ITT population (HR, 0.70 98.22% CI, 0.55-0.90 P<. To be eligible for the trial, the high-risk population of patients with MIUC who had previously undergone radical surgery needed to have undergone radical surgery with or without cisplatinbased chemotherapy within 120 days prior to randomization. DFS was also evaluated in prespecified subgroups. Moreover, distant metastasis-free survival (DMFS) was an exploratory end point.
The key secondary end point was non–urothelial tract recurrence-free survival (NUTRFS) in the ITT population and in patients with PD-L1 expression of 1% or greater. The primary end point of the study was DFS for all patients in the ITT population, as well as those with a PD-L1 expression of 1% or greater.
#CHECKMATE 274 TRIAL#
A dose of 240 mg of nivolumab or placebo was administered every 2 weeks intravenously for up to 1 year or until disease recurrence or trial discontinuation. Patients were randomized 1:1 and stratified based on PD-L1 expression, pathological nodal status, and treatment with a neoadjuvant cisplatin-based chemotherapy. The randomized, double-blind, multicenter CheckMate 274 trial enrolled 709 patients with high-risk MIUC originating in the bladder, ureter, or renal pelvis, including 353 in the ITT nivolumab group (PD-L1 ≥ 1%, n=140) and 356 in the placebo group (PD-L1 ≥ 1%, n=142). This disease-free survival benefit was observed in both the intent-to-treat population and in the subset of patients with tumors harboring high levels of PD-L1 expression a disease-free survival benefit with nivolumab was observed in most prespecified clinical subgroups,” Matthew Galsky, MD, professor of medicine (hematology and medical oncology), director of genitourinary medical oncology, codirector of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute and associate director for translational research at The Tisch Cancer Institute at Mount Sinai in New York, New York, said during a virtual presentation of the poster. “With longer follow-up, nivolumab continued to demonstrate a clinically meaningful improvement in disease-free survival vs placebo for patients with high-risk muscle-invasive urothelial cancer after radical surgery. Treatment with the immune checkpoint inhibitor nivolumab (Opdivo) continued to induce improved disease-free survival (DFS) among patients with high-risk muscle-invasive urothelial carcinoma (MIUC) following radical surgery, regardless of previous treatment with neoadjuvant chemotherapy, nodal involvement, or PD-L1 status, according to extended follow-up from the phase 3 CheckMate 274 trial (NCT02632409) presented at the 22nd Annual Meeting of the Society of Urologic Oncology in December 2021.
0 kommentar(er)
