A report on the CheckMate 274 clinical trial results presented at the 2022 American Urological Association (AUA) meeting showed that the immunotherapy drug nivolumab (Opdivo) helps reduce cancer recurrence in bladder cancer patients and reduces the chance of reoccurring tumors.
The clinical trial findings were presented at the AUA by Matthew Galsky, MD, Director of genitourinary medical oncology at the Mount Sinai Tisch Cancer Center in New York City. The phase 3, randomized, double-blind trial, CheckMate 274, included about 700 patients with urothelial cancer that had spread to the muscle, who received surgery with chemotherapy, with half of the group given Opdivo and the other half receiving a placebo.
Patients were given Opdivo or placebo every two weeks for up to one year, or until disease recurrence, or discontinuation from the trial. After a minimum of 11 months follow-up, the patients who were given Opdivo had a 30% lower likelihood of developing cancer recurrence than the placebo group, and 77% of patients were found to be recurrence-free outside of the urothelial tract at six months.
Opdivo is administered intravenously and blocks a tumor’s ability to grow by attaching to the PD-1 receptor. Treatment is typically administered several times a week over the course of one year. Standard treatment for urothelial cancer patients whose cancer has spread to muscle or lymph nodes has typically been surgery to remove the affected organ. However, research shows that about 50% of these patients relapse with metastatic cancer, making Opdivo a potential new standard of care for urothelial cancer patients.
“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,” noted Galsky. “Demonstrating consistent results with longer follow-up is quite important to reinforcing the role for this therapy.”
Xinhua Zhu, MD, PhD, medical oncologist and hematologist at Northwell Health Cancer Institute in New York City, said that the patients tolerated the treatment well. He noted that Opdivo has already been the standard treatment for metastatic bladder cancer for over a year and that immunotherapy is much more tolerable for patients than typical chemotherapy.
While the study only covered Opdivo’s benefit over 11 months, Zhu notes that the drug will have a notable survival benefit. Dr. Galsky remarked that “demonstrating consistent results with longer follow-up is quite important to reinforcing the role for this therapy.” Follow-up with patients from the CheckMate 274 trial is ongoing.
References
Immunotherapy Drug Can Lower Recurrence When Bladder Cancer Spreads
