Notably, 53.3% and 56.3% in the nivolumab and placebo groups, respectively, discontinued treatment. Additionally, 43.3% and 43.5% of patients received neoadjuvant cisplatin-based combination therapy in both the nivolumab cohort and placebo cohort, respectively. Lymph nodes with urothelial carcinoma invasion was common in both groups and included 47.3% of those in the nivolumab group and 47.2% in the placebo group. The key secondary end point was survival free from recurrence outside the urothelial tract. The primary end point of the study was DFS for all patients in the intent-to-treat (ITT) population, as well as those with a PD-L1 expression of 1% or greater. Additionally, an ECOG performance status of 0 or 1 was required. To be eligible for the trial, patients needed to have undergone radical surgery with or without cisplatin-based chemotherapy within 120 days prior to randomization. ![]() The trial included a high-risk population of patients with MIUC who had previously undergone radical surgery. A dose of 240 mg of nivolumab or placebo was administered every 2 weeks intravenously for up to a 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. Additionally, 140 patients in the nivolumab arm and 142 in the placebo arm had a PD-L1 expression of 1% or more. Overall, the randomized, double-blind phase CheckMate 274 clinical trial (NCT02632409) enrolled a total of 709 patients, including 353 in the ITT nivolumab group and 356 in the placebo group. The agency is scheduled to make its final decision on the application on or before September 3, 2021. ![]() 001).īased on the results of CheckMate 274, the FDA previously granted a priority review to adjuvant nivolumab for use in this setting. At the 6-month follow-up, 74.9% of patients in the nivolumab group and 60.3% in the placebo group were alive and disease free (HR 0.70 P<. 1Īfter a median follow-up of 20.9 months (range, 0.1-48.3) in the nivolumab cohort and 19.5 months (range, 0-50.0) for patients in the placebo cohort, investigators reported a median DFS of 20.8 months in the nivolumab group and 10.8 months in the placebo group. Adjuvant nivolumab (Opdivo) reduced the risk of disease relapse or death by 30% versus placebo in patients with muscle invasive urothelial carcinoma (MIUC), according to the results from the phase 3 CheckMate 274 trial published in the New England Journal of Medicine.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |