FDA sBLA Submitted for Anktiva Plus BCG in Papillary Bladder Cancer

A supplemental Biologics License Application (sBLA) has been submitted to the U.S. Food and Drug Administration (FDA) for the use of Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease, it has been announced.

The sBLA submission, which occurred in the first quarter of 2025, was noted in a news release issued by immunotherapy company ImmunityBio, Inc.

The FDA had previously approved Anktiva with BCG for adult patients with BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors in April 2024. A supplemental biologics application is submitted to the FDA when a manufacturer is seeking approval of a new indication for a drug that has been previously approved for a different indication.

As ImmunityBio explained in its news release, subject to regulatory approvals the addition of the papillary indication would allow more patients to avoid the high morbidity and mortality associated with radical cystectomy, or surgical removal of the bladder.

The data that were submitted to the FDA showed that, among 88% and 82% of subjects, the probability of avoiding surgery to remove their bladder was achieved for up to two years and three years, respectively, after receiving treatment with Anktiva plus BCG, according to the news release.

The treatment combination of Anktiva and BCG, according to study findings published in 2022 in NEJM Evidence, was associated with a disease-free survival rate of 55.4% at 12 months, 51.1% at 18 moths and 48.3% at 24 months among patients with papillary NMIBC, the news release noted. Furthermore, 93% of patients were able to avoid surgical removal of the bladder at a median follow-up of 20.7 months.

“In patients with BCG-unresponsive bladder carcinoma in situ and papillary NMIBC treated with BCG and the novel agent [Anktiva], [complete responses] were achieved with a persistence of effect, cystectomy avoidance, and 100% bladder cancer–specific survival at 24 months,” wrote Dr. Karim Chamie and colleagues in NEJM Evidence at the time.

Chamie is an associate professor of urology at UCLA in Los Angeles.

As the American Cancer Society explained on its website, in non-invasive bladder cancer the cancer cells are limited to the inner layer of the bladder wall and have not grown into the deeper layers. Non-invasive papillary carcinomas grow in thin, finger-like projections from the inner wall of the bladder toward the hollow center, according to the American Cancer Society.

Anktiva, as defined by the National Cancer Institute on its website, works by binding to receptors for the protein interleukin-15, or IL-15, which is found on certain types of immune cells. This action may help the immune cells kill cancer cells. The drug is a type of immunotherapy known as an IL-15 receptor agonist.

BCG, as the National Cancer Institute also explained on its website, is a weakened form of the bacterium Mycobacterium bovis that does not cause disease, and is used in a solution to stimulate the immune system in the treatment of bladder cancer.

“The FDA’s approval of Anktiva marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors,” said Dr. Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a news release issued at the time of the regimen’s 2024 approval. “Anktiva not only proliferates and activates the patient’s own NK cells and CD8+ killer T cells, but also activates CD4+ T helper cells, thus enhancing the proliferation of memory killer T cells. This novel mechanism of action, which mimics the biology of the dendritic cell, begins the evolution of immunotherapy beyond T cells alone. The combination of the proliferation of key cancer-killing immune cells, together with the activation of T cells with memory, results in durable complete responses. The ‘triangle offense’ of tumor cell killing by the body’s immune system with long-term memory is the foundation of our efforts to develop a therapeutic cancer vaccine across multiple tumor types, regardless of the site of origin.”

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.