Bristol-Myers announces three-year results from Phase 3 CheckMate-274 trial

Bristol Myers Squibb announced three-year follow-up results from the Phase 3 CheckMate -274 trial, demonstrating significant sustained clinical benefits with Opdivo 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, non-urothelial tract recurrence-free survival, distant metastasis-free survival and second progression-free survival compared to placebo across all-randomized patients and in patients whose tumor cells express PD-L1 greater than or equal to1%. These updated results will be featured in a late-breaking oral presentation at the American Society of Clinical Oncology 2023 Genitourinary Cancers Symposium from February 16-18, 2023. With three years of follow-up in the CheckMate -274 trial: 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. In patients whose tumor cells express PD-L1 greater than or equal to1%, Opdivo extended the average length of time patients lived without disease recurrence more than six times compared to placebo, with median DFS of 52.6 months vs. 8.4 months with placebo, a 48% reduction in the risk of disease recurrence or death. NUTRFS: In all randomized patients, those treated with Opdivo showed a median NUTRFS, defined as the time that patients lived without disease recurrence outside of the bladder, ureters or renal pelvis, of 25.9 months compared to 13.7 months for placebo. In patients whose tumor cells express PD-L1 greater than or equal to1%, median NUTRFS was 52.6 months with Opdivo vs. 8.4 months with placebo. DMFS: Across all randomized patients, median DMFS, defined as the time that patients live without cancer spreading from the primary tumor to distant organs or lymph nodes, was 47.1 months with Opdivo vs. 28.7 months with placebo. Among patients whose tumor cells express PD-L1 greater than or equal to1%, median DMFS was not reached with Opdivo, compared to 20.7 months with placebo. PFS2: Median PFS2, defined as the time from randomization to disease progression after subsequent next-line systemic therapy, start of second subsequent next-line systemic therapy, or death, was 61.2 months for all-randomized patients treated with Opdivo compared to 47.1 months with placebo. In patients whose tumor cells express PD-L1 greater than or equal to1%, median PFS2 was not reached with Opdivo vs. 39.4 months with placebo. Safety: Grade 3-4 treatment-related adverse events occurred in 18.2% and 7.2% of patients in the Opdivo and placebo arms, respectively, consistent with the primary analysis.