FDA approves adjuvant nivolumab in bladder cancer


The FDA has approved nivolumab (Opdivo) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement, or PD-L1 status, Bristol Myers Squibb announced in a news release.1

The approval’s basis comes from the randomized, double-blind phase 3 CheckMate -274 trial (NCT02632409), which evaluated nivolumab, 240 mg in 353 patients vs 356 patients receiving placebo.2 Patients who received nivolumab had a median disease-free survival of 20.8 months (95% Confidence Interval [CI]: 16.5 to 27.6) vs 10.8 months (95% CI: 8.3 to 13.9) in the placebo arm.

In the release, Checkmate -274 primary investigator Matthew Galsky, MD, hailed the approval as a “major milestone for patients who have undergone major surgery to remove the bladder or parts of the urinary tract and are in need of additional treatment approaches that can help reduce the risk of their UC returning.

“Nivolumab provides a new FDA-approved treatment shown to reduce the risk of disease recurrence or death based on the safety and efficacy findings from CheckMate -274, and has the potential to become a new standard of care option in this setting,” added Galsky, professor of medicine, director of Genitourinary Medical Oncology, co-director of the Center of Excellence for Bladder Cancer, and associate director for Translational Research at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai, New York.

Additional findings from the study indicated that 74.5% of patients in the nivolumab arm who had a PD-L1 expression of 1% or higher were alive and disease-free at 6-months vs 55.7% of those in the placebo (HR 0.55; P < .001). A subgroup analysis identified a higher probability of DFS following treatment with nivolumab vs placebo regardless of nodule or PD-L1 status or use or non-use of previous neoadjuvant chemotherapy. At the database lock, 83.6% of patients were still receiving nivolumab or the placebo.

Moreover, investigators reported a median survival free from recurrence outside of the urothelial tract of 22.9 months for the nivolumab ITT population and 13.7 months for the placebo ITT population. At the 6-month follow-up, 77.0% in the nivolumab group and 62.7% in the placebo group were alive and disease free (HR 0.72. Among patients who had a PD-L1 expression of 1% or more, 75.3% in the nivolumab group and 56.7% in the placebo group were alive and free from recurrence outside the urothelial tract at 6 months (HR 0.55).

Treatment with nivolumab also yielded a longer median distant metastasis-free survival (MFS) of 40.5 months, and 29.5 months for the placebo group. Investigators also reported a 6-month distant MFS of 82.5% and 69.8% in both the nivolumab and placebo cohort, respectively (HR 0.75). Those who had a PD-L1 expression of 1% or more had a 6-month distant MFS of 78.7% and 65.7% in both groups, respectively (HR 0.61).

Adverse effects (AEs) occurred in 98.9% of patients who were treated with adjuvant nivolumab and 95.4% of those who received the placebo. AEs that were grade 3 or higher occurred in 42.7% of patients in the nivolumab arm and 36.8% in the placebo arm.

Also in the release, Adam Lenkowsky, senior vice president and general manager of U.S. Cardiovascular, Immunology and Oncology at Bristol Myers Squibb, commented, “UC is the third type of cancer where Opdivo has been the first approved PD-1 inhibitor in the adjuvant setting,” “Now with this advancement, we can offer new hope to the conversations between healthcare providers and their UC patients where historically no approved treatment options have existed to help prevent disease recurrence post-surgery.”


1. U.S. Food and Drug Administration approves Opdivo (nivolumab) for the adjuvant treatment of patients with high-risk urothelial carcinoma. News release. Bristol Myers Squibb. August 20, 2021. Accessed August 20, 2021. https://bit.ly/3y8Yfo5

2. Bajorin DF, Witjes JA, Gschwend JE, et al. Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. N Engl J Med. 2021;384(22):2102-2114. doi:10.1056/NEJMoa2034442.

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