Immunotherapy Nivolumab Doubles Disease-Free Survival in a Type of High-Risk Urothelial Carcinoma

For immediate release
February 8, 2021


Rachel Cagan


“Even with the current standard of care — surgery with or without pre-surgery chemotherapy —muscle-invasive urothelial carcinoma has a high risk of recurring. These new findings show that treating patients at highest risk of recurrence with an immunotherapy after surgery can help extend the time until the disease returns,” said Robert Dreicer, MD, MS, MACP, FASCO, ASCO expert in genitourinary cancers.

ALEXANDRIA, Va. —Treatment with the immunotherapy nivolumab (Opdivo®) following radical surgery with or without cisplatin-based chemotherapy significantly improved disease-free survival in patients with muscle-invasive urothelial carcinoma, according to a study that will be presented at the 2021 ASCO Genitourinary Cancers Symposium, taking place virtually February 11-13.

The results come from the phase III CheckMate 274 trial of adjuvant nivolumab in patients who underwent radical surgery (surgery intended to remove all diseased tissue) for high-risk muscle-invasive urothelial carcinoma of the bladder, ureter, or renal pelvis.

Study At-a-Glance


Effect of treatment with nivolumab following surgery with or without pre-surgery chemotherapy


709 patients with muscle-invasive urothelial cancer at high risk of relapse despite being treated with surgery with or without pre-surgery chemotherapy


Among all randomized patients, disease-free survival was improved for those treated with nivolumab after surgery compared with those who received placebo — median 21 months with nivolumab vs. median 10.9 months with placebo.


Adjuvant nivolumab provides a clinically meaningful improvement in disease-free survival for patients with high-risk muscle-invasive urothelial carcinoma after radical surgery with curative intent, irrespective of PD-L1 status.


Key Findings
Median disease-free survival—the time between the end of primary treatment and the return of signs or symptoms of cancer—was significantly longer for patients who received post-surgery treatment with nivolumab (median 21 months) compared with those who received placebo (median 10.9 months). Disease-free survival for a subset of patients with tumors positive for a certain type of protein (PD-L1) was also improved with nivolumab (median, however, not yet reached by the time of analysis).

“Nivolumab is the first immune therapy to be used in the adjuvant setting that provides a statistically significant and clinically meaningful improvement in disease-free survival for patients with high-risk muscle-invasive urothelial carcinoma after radical surgery with curative intent, irrespective of PD-L1 status,” said lead author Dean F. Bajorin, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York.

About the Study
The study involved 709 patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or renal pelvis who underwent radical surgery with or without pre-surgery (neoadjuvant) cisplatin-based chemotherapy. There was a high risk for recurrence based on the tumor stage at surgery. Patients were randomized to receive nivolumab or placebo every other week for 1 year.

Nivolumab is an immunotherapy that works by blocking the protein PD-L1 from binding to another protein (PD-1) found on T cells, which are part of the immune system. When PD-L1 and PD-1 bind, T cells are prevented from killing cancer cells. By blocking PD-L1, nivolumab allows T cells to kill cancer cells.

The standard-of-care treatment for muscle-invasive urothelial carcinoma is cisplatin-based neoadjuvant therapy followed by radical surgery — removal of the bladder. However, some patients may be ineligible to receive cisplatin due to factors like inadequate kidney function. Adjuvant nivolumab could provide a treatment option for these patients to reduce the risk of recurrent cancers and death.

More serious treatment-related side effects (grade 3–4) were seen among patients who received nivolumab (17.9%) than those who received placebo (7.2%). The most common grade 3 or higher treatment-related side effects were diarrhea, colitis, and pneumonitis in the nivolumab arm and colitis, diarrhea, gamma-glutamyl transferase (GGT) increase, and hepatitis in the placebo arm.

Next Steps
In order to examine the impact of nivolumab on overall survival and cancer-specific survival, longer follow-up is needed. 

The study received funding from Bristol Myers Squibb in collaboration with ONO Pharmaceutical Company Ltd.

For Your Readers



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The Society of Urologic Oncology (SUO) was created in 1984 to enable qualified members primarily interested in the care of patients with malignant genitourinary diseases to meet for the purpose of discussion, development, and implementation of ideas to improve care. The Society and its bylaws conform to the guidelines and bylaws of the American Urological Association (AUA).

The purpose of the SUO is to develop educational and research initiatives and to study issues in urologic oncology and provide physician statements that represent a state-of-the-art assessment of these issues to other organizations.

The Society also provides a forum for identifying the urologic oncologist as a physician with specific expertise in the study and treatment of genitourinary malignancies. In recognition of the multidisciplinary efforts involved in the study and treatment of genitourinary malignancies, the Society seeks to incorporate multiple disciplines in achieving these goals. The Society supports the activities of multiple disciplines in the common objectives of seeking an increased understanding and successful treatment of genitourinary malignancies.

The SUO seeks to improve the care of patients with malignant urologic disease and to provide a forum for the discussion of problems relating to malignant urologic disease. Our objectives include: 1) Stimulating research in and the teaching of urologic oncology, 2) Disseminating the principles of urologic oncology to the medical profession at large, 3) Bringing urologists into a Society whose work is entirely, or principally with malignant disease, 4) Being identified as the most qualified organization on matters relating to urologic oncology, and 5) Standardize fellowship training in urologic oncology.

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