Plain Language Review Explains Innovative Bladder Cancer Therapy

A recent Plain Language Summary of Publication stated ImmunityBio Inc.'s newly approved Anktiva® (N-803) plus Bacillus Calmette-Guérin (BCG) vaccine combination therapy produced positive results for certain bladder cancer patients.

The review of two company-sponsored clinical trials concluded that the addition of the IL-15 superagonist N-803 to BCG therapy produces a high rate of success in eliminating non-muscle invasive bladder cancer in both BCG-naive and BCG-unresponsive patients, with long-lasting effects that allow patients to avoid surgical removal of the bladder.

This clinical information is vital since bladder cancer treatment costs about $2 billion annually. 

One small study was a Phase 1b study that tested increasing doses of N-803 in combination with the same dose of BCG in people with NMIBC who had never received BCG previously (BCG-naive).

The other study is a Phase 2/3 study of N-803 and BCG in people with NMIBC whose cancer wasn't eliminated by BCG alone (BCG unresponsive).

Treatments were delivered directly into the bladder once a week for six consecutive weeks.

In the Phase 1b study, the nine participants were split into three groups of 3 who received 100, 200, or 400 μg N-803 doses along with a standard 50 mg dose of BCG. In the Phase 2/3 study, one group (cohort A) of participants with carcinoma in situ disease and another group (cohort B) with papillary disease were treated with 400 μg N-803 plus 50 mg BCG. There was also a cohort C that received only 400 μg N-803.

Published by the journal Taylor and Francis Online on July 2, 2024, N-803 plus BCG eliminated NMIBC in all nine BCG-naive participants, and the effects were long-lasting, with participants remaining NMIBC-free for a range of 8.3 to 9.2 years.

In April 2024, ImmunityBio announced that the U.S. Food and Drug Administration had approved ANKTIVA plus BCG. On June 20, 2024, ImmunityBio announced the initial treatments in the U.S. had begun.

The 100-year-old BCG vaccine has been a well-established immunotherapy for NMIBC since the 1970s. 

The authors of this review are affiliated with ImmunityBio, Inc., the manufacturer of N-803 and sponsor of the studies.