Immunotherapies move toward FDA approval for urothelial Ca
Two investigational immunotherapy drugs, pembrolizumab (Keytruda) and nivolumab (Opdivo), are making progress toward FDA approval for treatment of urothelial carcinoma.
Last month, Merck announced that the anti-PD-1 (programmed cell death protein 1) therapy, pembrolizumab, met the primary endpoint of overall survival in a phase III trial investigating its use in patients with previously treated advanced urothelial cancer. The drug was superior compared to chemotherapy, and an independent data monitoring committee recommended the trial be halted because it met its primary endpoint.
In related news, Bristol-Myers Squibb announced that nivolumab, also a PD-1 inhibitor, has been granted priority review by the FDA for second-line therapy in advanced urothelial carcinoma. The company hopes to expand the treatment’s use to patients with locally advanced unresectable or metastatic urothelial carcinoma that has progressed on or after platinum-containing therapy.
Immune checkpoint inhibitors can be considered a game-changer in urothelial bladder cancer, according to Urology Times Editorial Council member Leonard G. Gomella, MD, of Thomas Jefferson University, Philadelphia.
“Strong basic science and clinical evidence exist for the use of immunotherapy in the treatment of all stages of urothelial carcinoma. Urothelial cancers have been shown to express compounds that suppress the immune system. New immunotherapies directed against urothelial carcinoma include ‘checkpoint inhibitors’ that can reverse the tumor-related immune suppression and allow more effective immunotherapy-mediated tumor killing,” said Dr. Gomella, who is also the current president of the Society of Urologic Oncology.
The PD-L1 protein is found on certain tumor cells and binds to a receptor, PD-1, on immune cells, which results in immune suppression, Dr. Gomella explains.
“The use of monoclonal antibody checkpoint inhibitors (anti PD-1 and anti PD-L1) has demonstrated significant antitumor activity in patients with metastatic urothelial carcinoma who have failed cisplatin-based therapy, the current standard for advanced urothelial carcinoma,” he said.
Another PD-L1 inhibitor, atezolizumab (Tecentriq), was approved in May 2016 as second-line therapy for urothelial carcinoma.