(UroToday.com) During the 2023 American Urological Association’s Late Breaking Abstract II - Cancer session, Dr. Matthew Milowsky presented results from extended follow-up in patients with muscle-invasive bladder cancer in the CheckMate 274 trial. Even with radical surgery incorporated into treatment algorithms, patients with muscle-invasive urothelial carcinoma (MIUC) are at risk for lethal metastatic recurrence. Based on initial results from CheckMate 274, adjuvant nivolumab after radical surgery is now considered standard of care after improvements in disease free survival (DFS), non-urothelial tract recurrence-free survival (NUTRFS), and distant metastasis-free survival (DMFS) were demonstrated. Dr. Milowsky presented extended follow-up data (median follow up, 3 years) from the trial data, focusing on the muscle-invasive bladder cancer (MIBC) cohort.
He reviewed that inclusion criteria for this phase 3 clinical trial included ypT2 – ypT4a or ypN+ MIUC with or without neoadjuvant chemotherapy (NAC), and those who are ineligible or refuse adjuvant cisplatin chemotherapy (if no NAC). Dr. Milowsky noted that the interval from surgery was within 120 days. Patients were randomized in a 1:1 fashion with nivolumab versus placebo. Baseline characteristics are noted:
Dr. Milowsky highlighted that approximately 40% of patients had PD-L1 expression ≥1%, and approximately 40% had prior NAC.
Next, he reviewed the DFS endpoint, showing a continued benefit in both the intention-to-treat (ITT) and MIBC populations. Further, this benefit was seen in all patients with PD-L1 ≥1% and patients with MIBC, regardless of PD-L1 status.
Secondary and exploratory endpoints of the trial were also presented:
From a safety standpoint, most common adverse events were pruritis, fatigue, diarrhea, and rash.
Dr. Milowsky concluded the presentation as follows:
- With a median follow up of 3 years, a consistent benefit in DFS, NUTRFS, DMFS, and PFS2 was demonstrated with the use of adjuvant nivolumab versus placebo
- The magnitude of DFS, NUTRFS, and DMFS benefit was overall stable
- Within the MIBC population, DFS benefit was evident regardless of PD-L1 expression level
- Safety in the MIBC arm was consistent with prior data in the ITT population
- These results further reinforce the use of adjuvant nivolumab for high risk MIUC and MIBC after radical surgery
Presented by: Matthew Milowsky, MD, FASCO, UNC Lineberger Comprehensive Cancer Center
Written by: Ruchika Talwar, MD, Urologic Oncology Fellow, Vanderbilt University Medical Center, during the 2023 American Urological Association (AUA) Annual Meeting, Chicago, IL, April 27 – May 1, 2023