About 40% patients in both arms were PD-L1 positive and about 43% had received prior cisplatin based neoadjuvant chemotherapy. In the placebo arm, the tumor of origin was urinary bladder in 78.9% of patients and upper tract disease in 21.1% of patients. This was mostly commonly due to disease recurrence.Īmong patients in the nivolumab arm, the tumor of origin was urinary bladder carcinoma in 79% of patients and upper tract disease in 21% of patients. In the nivolumab arm, 53.3% of patients discontinued treatment, and in the placebo arm, 56.3% of patients discontinued. In total, 353 patients were randomized to nivolumab and 356 patients to placebo. The median follow-up was 20.9 months for nivolumab and 19.5 months for placebo. The primary endpoint of the study was DFS in the ITT population and in patients with tumor PD-L1 expression ≥ 1%. Eligible patients had radical surgery within 120 days with or without neoadjuvant cisplatin or were ineligible/declined cisplatin-based chemotherapy, and were disease-free as evidenced by imaging. Patients (N = 709) were randomized 1:1 to receive nivolumab 240 mg administered once every 2 weeks or placebo for up to 1 year of adjuvant treatment. The randomized, double- blind CheckMate-274 (NCT02632409) evaluated the efficacy and safety of adjuvant nivolumab versus placebo in patients with high-risk MIUC after radical surgery. “These results support nivolumab monotherapy as a new standard of care in the adjuvant setting for patients with high-risk MIUC after radical surgery regardless of PD-L1 status and prior neoadjuvant chemotherapy.” “Nivolumab is the first systemic immunotherapy to demonstrate a statistically significant and clinically meaningful improvement in outcomes when administered as adjuvant therapy to patients with muscle-invasive urothelial carcinoma,” he said. In the PD-L1–positive population, NUTRFS in those treated with nivolumab was not reached versus 10.9 months in the placebo group (HR, 0.54 95% CI, 0.38-0.77). In the ITT population, those treated with nivolumab experienced NUTRFS of 24.6 months versus 13.7 months in the placebo group (HR, 0.72 95% CI, 0.58-0.89). The monoclonal antibody also improved median non–urothelial tract recurrence-free survival (NUTRFS), a secondary endpoint, and the exploratory endpoint of distant metastasis free survival (DMFS) in both the ITT and the PD-L1 positive patient populations. “This corresponds to a 47% reduction in the risk of disease recurrence or death with nivolumab,” Bajorin said.Ī subgroup analysis of the ITT population found there were no differences age, sex, region or performance status, he added. In the PD-L1 positive population, the median DFS in those treated with nivolumab was not reached compared with 10.8 months in the placebo group (HR, 0.53 98.87% CI, 0.34-0.84 P <. “The median DFS is nearly double with nivolumab compared to placebo.” Adler Senior Faculty Chair at Memorial Sloan Kettering Cancer Center in New York, New York. “This corresponds to a 30% reduction in the risk of disease recurrence or death with nivolumab,” said lead author Dean Bajorin, MD, the Frederick R. In the ITT population, DFS in those treated with nivolumab was 21.0 months compared with 10.9 months with placebo (HR, 0.70 98.31% CI, 0.54-0.89 P <. Investigators found that adjuvant nivolumab conferred a median DFS benefit in both the intent-to-treat (ITT) and PD-L1–positive populations. Nivolumab (Opdivo) following surgery extended disease-free survival (DFS) compared with placebo for patients with muscle-invasive urothelial carcinoma (MIUC), according to results from the phase 3 CheckMate-274 trial presented at the 2021 ASCO Genitourinary Cancer Symposium.
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