Pembrolizumab Boosts Survival in Muscle-Invasive Urothelial Cancer

FRIDAY, Sept. 20, 2024 -- A recent study has demonstrated that disease-free survival is significantly longer for patients with high-risk muscle-invasive urothelial carcinoma who receive adjuvant pembrolizumab compared to those who are merely observed after undergoing radical surgery. These findings were published online on Sept. 18 in the New England Journal of Medicine, coinciding with the annual meeting of the European Society for Medical Oncology held in Barcelona, Spain from Sept. 13 to 17.

Led by Dr. Andrea B. Apolo from the National Institutes of Health in Bethesda, Maryland, the study was a phase 3 trial that included patients diagnosed with high-risk muscle-invasive urothelial carcinoma. The participants were randomly assigned into two groups: one group received pembrolizumab (200 mg) every three weeks for a year, comprising 354 patients, while the other group, consisting of 348 patients, was placed under observation following radical surgery. The main objectives of the study were to measure disease-free and overall survival rates among the intention-to-treat population.

As of July 5, 2024, patients had a median follow-up period of 44.8 months for disease-free survival. The results indicated that the median disease-free survival was 29.6 months for the pembrolizumab group compared to just 14.2 months for the observation group. This translates to a hazard ratio of 0.73 for disease progression or death, suggesting a notable benefit from pembrolizumab in extending the period patients remain disease-free.

However, the treatment did come with increased adverse events. Grade 3 or higher adverse events occurred in 50.7 percent of patients receiving pembrolizumab, compared to 31.6 percent in the observation group.

"These findings collectively suggest that adjuvant checkpoint inhibitor therapy can extend disease-free survival for certain patients with high-risk muscle-invasive urothelial carcinoma," the authors concluded.