Bristol Myers Squibb announced three-year follow-up results from the Phase 3 CheckMate -274 trial, demonstrating significant sustained clinical benefits with Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma. With a median follow-up of 36.1 months , adjuvant Opdivo continued to show improved disease-free survival (DFS), non-urothelial tract recurrence-free survival , distant metastasis-free survival (DMFS) and second progression-free survival (PFS2) compared to placebo across all-randomized patients and in patients whose tumor cells express PD-L1 ≥1%. These updated results will be featured in a late-breaking oral presentation at the American Society of Clinical Oncology (ASCO) 2023 Genitourinary Cancers Symposium from February 16-18, 2023.
“Patients with muscle-invasive urothelial carcinoma face a high chance of recurrence due to micrometastatic disease, especially within the first three years after surgical removal of the bladder or kidney. The three-year results from CheckMate -274 show a stable decrease in the risk of disease with adjuvant nivolumab with longer follow-up,” said Matthew D. Galsky, M.D., Professor of Medicine, Director of Genitourinary Medical Oncology, Associate Director for Translational Research, and Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai. “Nivolumab remains the only immunotherapy, as well as the only medical treatment in general, to decrease the risk of urothelial cancer recurrence after radical surgery in patients who received chemotherapy prior to surgery or who are ineligible for chemotherapy. The results of this trial have changed the way that urothelial cancer is treated.”
DFS : Across all randomized patients, Opdivo more than doubled the average length of time patients lived without disease recurrence, demonstrating a median disease-free survival of 22.0 months compared to 10.9 months with placebo, a risk reduction of 29%. The risk reduction remained consistent with that observed at the primary analysis, with only a 1% change with an additional 25.7 months of minimum follow-up.
SOURCE: Businesswire