Researchers from Memorial Sloan Kettering Cancer Center (MSK) found that patients who received the immunotherapy therapy nivolumab (Opdivo®) following bladder cancer surgery had a lower risk for high-grade cancer recurrence. The study appeared in the New England Journal of Medicine.
In this phase III randomized, double-blind study, led by oncologist Dean Bajorin, MD, Dr. Bajorin and his colleagues assessed 709 patients at high risk for recurrence of urothelial cancer subsequent to removal of their bladder, ureter, or kidney for high-grade cancer. The population of interest were randomized to receive either nivolumab or a placebo every two weeks over the duration of one year. The investigators analyzed both treatment safety and patient quality of life. The primary endpoints were defined as disease-free survival in the study population and disease free-survival in the subset of patients with PD-L1-positive tumors.
Results Underscore the Benefits of Immunotherapy
According to the results, Dr. Bajorin and his team observed that in high-risk patients, nivolumab reduced recurrence after surgery in comparison to the control group receiving the placebo. Participants who received nivolumab had disease-free survival of 21 months compared with 10.9 months in people receiving the placebo, the researchers noted. Both primary endpoints were met. These findings are important because previously neither chemotherapy nor immunotherapy had demonstrated efficacy in preventing bladder cancer recurrence.
“We are very encouraged by the data and the results of the study,” said Dr. Bajorin, first and corresponding author of the study via a Sloan Kettering press release about the study. “Despite available therapies for advanced metastatic bladder cancer, new options are needed to improve long-term disease control and patient survival. These findings have the potential to change the standard of care for bladder cancer.”
The investigators concluded that the survival data is not yet conclusive and will require additional research to elucidate their findings. However, given that both primary endpoints were achieved, the research team believes that these findings are highly statistically significant and clinically relevant for a population of patients with a clear unmet medical need.
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“The trial demonstrates that novel therapies can be identified as having patient benefit when the studies are conducted in a very rigorous fashion. We are hoping this treatment will get approval for all patients at high risk of recurrence after the US Food and Drug Administration has done a detailed review of all the data,” Dr. Bajorin said.
Immunotherapy after bladder cancer surgery may reduce recurrence, study shows
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