The Food and Drug Administration (FDA) has approved ImmunityBio Inc’s IBRX Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. This approval marks a significant advancement in the treatment of bladder cancer and represents the first FDA-approved immunotherapy specifically for this indication.
Anktiva, a first-in-class IL-15 agonist immunotherapy, has demonstrated promising results in clinical trials. In a pivotal study, the combination of Anktiva and BCG achieved a complete response rate of 62%, with a median duration of complete response of over 47 months. These results are particularly noteworthy given the limited treatment options available for BCG-unresponsive NMIBC.
The FDA’s approval of Anktiva is based on the results of a Phase 3 clinical trial that evaluated the safety and efficacy of Anktiva in combination with BCG in patients with BCG-unresponsive NMIBC. The trial enrolled 77 patients, and the primary endpoint was complete response rate. The results showed that the combination of Anktiva and BCG was well-tolerated and resulted in a high rate of complete responses. The most common adverse events reported in the trial were fatigue, pyrexia, chills, and headache.
The approval of Anktiva is a major step forward in the fight against bladder cancer. This new immunotherapy offers a promising new treatment option for patients with BCG-unresponsive NMIBC, and it represents a significant advancement in the field of immunotherapy. Anktiva is expected to be available in the U.S. by mid-May 2024.
