What is Anktiva?
Anktiva (nogapendekin alfa inbakicept) is an FDA-approved recombinant interleukin-15 (IL-15) superagonist protein complex used in combination with Bacillus Calmette-Guérin (BCG) for treating adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. 1
Mechanism and Approval
Anktiva functions as an IL-15 superagonist that activates and expands natural killer cells and CD8+ T cells, enhancing the immune response against cancer cells 1, 2
The drug received FDA approval in April 2024 specifically for BCG-unresponsive NMIBC with CIS, representing a significant advancement for patients who have failed standard BCG therapy 1
Clinical Efficacy
In BCG-unresponsive patients with CIS disease, the combination of Anktiva (400 μg) plus BCG (50 mg) achieved complete response in 71% (58 of 82) of patients, with durable responses allowing approximately 90% of successfully treated patients to avoid cystectomy (surgical bladder removal). 3
For BCG-naive patients, all nine participants treated with Anktiva plus BCG achieved complete elimination of NMIBC, with cancer-free periods lasting 8.3 to 9.2 years 3
In patients with papillary disease (cohort B), 55.4% (40 of 72) remained cancer-free at 12 months after treatment 3
Anktiva used as monotherapy showed minimal efficacy (only 2 of 10 participants responded), confirming that the combination with BCG is essential for therapeutic benefit 3
Administration and Dosing
The approved regimen consists of 400 μg Anktiva plus 50 mg BCG delivered directly into the bladder (intravesical administration) once weekly for 6 consecutive weeks 3
The treatment is administered via bladder instillation, similar to standard BCG therapy 3
Safety Profile
The combination of Anktiva plus BCG demonstrated very few adverse events in both BCG-naive and BCG-unresponsive patient populations 3
The safety profile was acceptable across all dose levels tested (100,200, and 400 μg) in combination with standard BCG dosing 3
Beyond Bladder Cancer
Anktiva is also being investigated for other solid and hematological cancers, as well as HIV infection, though these indications are not yet approved 1
Research in HIV-infected macaques showed that Anktiva (N-803) combined with broadly neutralizing antibodies induced sustained viral control after antiretroviral therapy discontinuation in approximately 70% of treated animals 2