Three-Year Follow-Up of CheckMate -274 Trial: Opdivo Demonstrates Significant and Durable Clinical Survival Benefits as Adjuvant Therapy in Patients with High-Risk Urothelial Carcinoma after Radical Resection

The median three-year follow-up data showed that patients in the Opdivo adjuvant treatment group had significant improvements in disease-free survival, extravesical recurrence-free survival, distant metastasis-free survival, and progression-free survival compared to the placebo group.

In all randomized populations, the disease-free survival time in the Opdivo group remained more than twice that of the placebo group; Tumor CellsPD-L1Expression ≥1In % of patients, the disease-free survival time in the Opdivo group was more than six times that of the placebo group.

CheckMate -274The latest data from the study have been2023Presented at the Plenary Oral Session of the ASCO Genitourinary Cancers Symposium in the United States

ShanghaiFebruary 20, 2023PR Newswire -- Bristol-Myers Squibb recently announced the three-year follow-up results of the Phase III clinical study CheckMate -274:Opdivo( Nivolumab ) adjuvant treatment for patients with urothelial carcinoma who are at high risk of recurrence after radical resection can bring significant and durable clinical survival benefits. At a median follow-up time of 36.1 months (minimum 31.6 months), in all randomized populations and patients with tumor cell PD-L1 expression ≥1%, compared with the placebo control group,OpdivoPatients in the adjuvant treatment group showed sustained improvements in disease-free survival (DFS), no urinary tract recurrence-free survival (NUTRFS), distant metastasis-free survival (DMFS), and progression-free survival 2 (PFS2). These latest research data were presented as a high-impact oral report at the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) held from February 16-18, 2023.

"Due to the presence of micrometastases, patients with muscle-invasive urothelial carcinoma often face a high risk of recurrence, especially within three years after bladder or kidney removal surgery. The three-year results of the CheckMate -274 study indicate that with extended follow-up, adjuvant treatment with nivolumab consistently reduces the risk of disease recurrence."Icahn School of Medicine at Mount SinaiTischM.D., Ph.D., Director of the Department of Genitourinary Medical Oncology, Deputy Director of the Translational Research Division, Co-Director of the Bladder Cancer Center of ExcellenceMatthew GalskyProfessor"For patients who have received chemotherapy before surgery or are not suitable for chemotherapy, Nivolumab remains the only immunotherapy currently available to reduce the risk of recurrence of urothelial carcinoma after surgery, and it is also the only current drug treatment option. The results of this study can be said to have changed the treatment model for urothelial carcinoma."

The three-year follow-up results of the CheckMate -274 study are as follows:

"We have been committed to providing patients with safe and effective treatment options to help them prevent disease recurrence and improve long-term treatment outcomes. To this end, Bristol-Myers Squibb has made early treatment across multiple tumor types an important research focus, including difficult-to-treat cancers with significant unmet needs such as urothelial carcinoma."Head of Genitourinary Oncology Development at Bristol-Myers Squibb, M.D.Dana Walker"The durable benefits demonstrated in the CheckMate -274 study follow-up results are encouraging. This also motivates us to continue advancing our ongoing research in early-stage cancers, further exploring the potential of these studies to change patient outcomes. We will closely monitor the results of other key secondary endpoints in the CheckMate -274 study, including the overall survival results that remain blinded at present."

Bristol-Myers Squibb thanks all the patients and researchers who participated in the CheckMate -274 study.

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