First-in-class Immunotherapy Approved for Bladder Cancer
The FDA has approved nogapendekin alfa inbakicept-pmln, which stimulates immune cells to fight bladder cancer.
The U.S. Food and Drug Administration (FDA) has approved nogapendekin alfa inbakicept-pmln (Anktiva) in combination with Bacillus Calmette-Guérin (BCG), for the treatment of certain adult patients with non-muscle invasive bladder cancer (NMIBC) that has not responded to BCG alone. The treatment is intended for patients with carcinoma in situ (CIS), a patch of potentially aggressive cancer cells in the bladder lining, who may or may not also present with papillary tumors that grow into the bladder lumen.
Nogapendekin alfa inbakicept-pmln activates the IL-15 receptor on the surface of some immune cells, including T cells and natural killer cells. This helps the cells proliferate and boosts their activation so they are better able to fight cancer. This is the first approval for nogapendekin alfa inbakicept-pmln, and the drug is the first IL-15 receptor agonist to be approved by the FDA.
BCG is a therapeutic vaccine that helps to make bladder cancer cells more immunogenic, thus boosting the immune system’s response to the tumor. BCG has been approved for the treatment of bladder cancer since 1990 and is a common first-line treatment for NMIBC.
The approval for nogapendekin alfa inbakicept-pmln plus BCG was based on results from the single-arm, multicenter, phase II/III QUILT-3.032 clinical trial. Seventy-seven patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors, were treated with nogapendekin alfa inbakicept-pmln plus BCG following resection of their tumor.
Sixty-two percent of patients experienced complete responses, which lasted at least 12 months in 58% of these patients and at least 24 months in 40% of patients.
The recommended dose is 400 mcg instilled into the bladder with BCG once a week for six weeks. If the patient experiences a complete response in that time, they may continue to receive nogapendekin alfa inbakicept-pmln in three-week blocks during months 4, 7, 10, 13, 19, 25, 31, and 37; otherwise, the patient should repeat the six-week induction dosing. Treatment should be stopped after disease recurrence or progression, unacceptable toxicity, at a maximum of 37 months, or if complete response is not observed after the second six-week induction period.
Bladder cancer is a type of cancer that develops in the lining of the bladder. Around 75% of localized bladder cancer cases do not invade the bladder muscle wall and are classified as NMIBC. According to federal statistics, it was estimated that 83,190 individuals would be diagnosed with bladder cancer and 16,840 patients would die of the disease in the United States in 2024.
The FDA rendered its decision on April 22, 2024.
