Dr. Galsky on initial data from the CheckMate 274 trial in urothelial cancer
Matthew Galsky, MD, discusses the design and results of the CheckMate 274 Phase 3 trial in urothelial cancer.
Matthew Galsky, MD, Professor of Medicine, Hematology and Medical Oncology, Professor of Urology, Director of Genitourinary Medical Oncology, Co-Director of the Bladder Cancer Center of Excellence and Associate Director of the Translational Research at the Tisch Cancer Institute, Mount Sinai, discusses the design and results of the Phase 3 CheckMate 274 (NCT02632409) trial in urothelial cancer.
The CheckMate 274 trial is evaluating the use of adjuvant nivolumab (Opdivo) versus placebo in patients with high-risk muscle-invasive urothelial cancer.
The primary endpoint of the trial is disease-free survival (DFS) in the all-comer and PD-L1-positive populations, says Galsky. Assessing the subset of patients with PD-L1-expressing tumors will be important because nivolumab is a PD-1 antibody, and testing for the target can enrich the patient population that will benefit, Galsky says.
The first results of the trial, which were read with a minimum of 5.9 months of follow-up, showed a significant improvement in DFS with adjuvant nivolumab compared to placebo in the intent-to-treat and PD-L1 populations. -positive in the entire patient population, Galsky continues. Based on these data, the FDA approved the adjuvant nivolumab on August 20, 2021, Galsky concludes.