Immunotherapy with nivolumab (Opdivo) after surgery for metastatic bladder cancer significantly reduces the odds for the tumor's return, a new clinical trial finds.
Among 700 patients with urothelial cancer of the bladder or other parts of urinary tract that had spread to muscle, those treated with Opdivo were 30% less likely to have a recurrence over 11 months, compared with those who received a placebo, the phase 3 clinical trial found.
"This is the first immunotherapy to demonstrate a significant improvement in disease-free survival in patients with urothelial cancer — bladder cancer or urothelial cancer at other locations in the urinary tract," said researcher Dr. Matthew Galsky. He is director of genitourinary medical oncology at the Mount Sinai Tisch Cancer Center in New York City.
Urothelial cancers begin in cells lining various parts of the urinary system. The U.S. Food and Drug Administration approved nivolumab as a supplementary, or adjuvant, treatment for urothelial cancer.
"Demonstrating consistent results with longer follow-up is quite important to reinforcing the role for this therapy," Galsky said.
Opdivo is expensive, but since the FDA approved it, most insurers cover it, he said.
Surgery to remove the bladder or kidney and ureter has been the standard treatment for patients whose urothelial cancer has spread to muscle or lymph nodes. Researchers said about 50% of these patients relapse with deadly metastatic cancer.
Galsky said Opdivo was even more effective among patients whose tumors had the PD-L1 gene, and these patients were even less likely to have their cancer return. The trial was funded by the drug's maker Bristol Myers Squibb.
The study findings were presented Friday at a meeting of the American Urological Association in New Orleans. The survival data researchers presented at the meeting are based on initial data published by Galsky and his colleagues last year in The New England Journal of Medicine.
The immunotherapy drug is given intravenously and works by attaching to the PD-1 receptor, blocking the tumor's ability to grow. Treatment usually is given a couple of times a week over a year.
Dr. Xinhua Zhu, a medical oncologist and hematologist at Northwell Health Cancer Institute in New York City, said patients tolerate the treatment well. Side effects — which can include nausea, constipation and anemia — are generally mild and easily managed.
"I can tell you, based on my experience, immunotherapy is much, much more tolerable than the classical chemotherapy," said Zhu, reacting to the new findings.
He noted that Opdivo has been the standard treatment for metastatic bladder cancer for more than a year.
This study is the first to show the long-term benefit of the drug, Zhu added.
Although this study only showed the drug's benefit over 11 months, he expects that it will have a significant survival benefit.
"You know, half the patients will recur, that's a lot. It is really an aggressive type of cancer," Zhu said. "If we can get rid of the cancer or significantly delay the cancer recurrence, then the patient gets a tremendous benefit.