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Nogapendekin alfa inbakicept is an interleukin-15 (IL-15) receptor agonist, a type of protein-based medicine that enhances the body's immune response against cancer cells.[4] It is sold under the trade name Anktiva and was initially approved in the United States in 2024.[3] On 11 December 2025, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending conditional marketing authorisation for Anktiva in the European Union.[4] The applicant is ImmunityBio Ireland Limited.[4]
Nogapendekin alfa inbakicept acts as an IL-15 receptor agonist, meaning it activates the same signalling pathway as the natural immune protein interleukin-15. This stimulation enhances immune responses by activating CD4+ and CD8+ T cells as well as NK cells, which are types of white blood cells that can recognise and destroy cancer cells.[4] In bladder cancer, the medicine is administered directly into the bladder together with BCG, a weakened bacterium that also stimulates an immune reaction against tumour cells in the bladder lining.[3]
Anktiva is available as a 400 microgram concentrate for intravesical suspension, meaning it is diluted and then instilled directly into the bladder through a catheter.[4] The US prescribing information describes an induction course of 400 micrograms given intravesically with BCG once a week for 6 weeks, with a possible second induction course if a complete response is not achieved at month 3. Maintenance treatment is given once a week for 3 weeks at months 4, 7, 10, 13 and 19, with additional maintenance instillations possible at months 25, 31 and 37 for patients with an ongoing complete response.[3] In the Phase 3 lung cancer trial, N-803 is given by subcutaneous injection at a dose of 1.2 mg.[2]
The registry contains two trials. The Phase 2 trial (NCT02138734) enrolled 596 participants with non-muscle invasive bladder cancer and compared N-803 plus BCG against BCG alone. Its primary measures were the complete response rate at 6 months in patients with carcinoma in situ, and disease-free survival in patients with high-grade papillary disease.[1] The Phase 3 trial (NCT06745908) is authorised and plans to enrol 578 participants with advanced or metastatic non-small cell lung cancer who have acquired resistance to immune checkpoint inhibitor therapy. It compares overall survival between experimental arms combining N-803 with tislelizumab or docetaxel and a control arm of docetaxel alone.[2] The European public assessment for Anktiva reports a 71% complete response rate and a median duration of complete response of 26.6 months in a single-arm, open-label, phase 2/3 study in adults with BCG-unresponsive NMIBC with CIS.[4]
The most common side effects reported with Anktiva include dysuria (painful urination), haematuria (blood in the urine), pollakiuria (frequent urination), urinary tract infection, micturition urgency, fatigue, chills, musculoskeletal pain and pyrexia (fever).[4] The US prescribing information additionally lists increased creatinine, increased potassium, and urinary frequency as common adverse reactions occurring in at least 15% of patients.[3] A warning in the US label notes that delaying surgical removal of the bladder (cystectomy) can lead to the development of metastatic bladder cancer, which can be lethal.[3]
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