{"entity":{"id":"nogapendekin-alfa","kind":"drug","name":"Nogapendekin alfa inbakicept","aka":["ALT-803","NAI","nogapendekin-alfa-inbakicept"],"tldr":"Nogapendekin alfa inbakicept is an engineered version of the immune-boosting protein IL-15, given with BCG into the bladder, approved in 2024 for early bladder cancer that BCG alone no longer controls.","summary":"Nogapendekin alfa inbakicept is an IL-15 superagonist, an IL-15/IL-15R alpha-Fc fusion that expands natural killer cells and memory CD8 T cells without preferentially stimulating regulatory T cells. It is instilled into the bladder together with BCG, weekly for 6 weeks and then as maintenance for up to 37 months. In QUILT 3.032 the combination produced a complete response in 71% of patients with BCG-unresponsive carcinoma in situ, with long bladder preservation in responders. The FDA approved it on 22 April 2024 after a 2023 complete response letter over manufacturing; side effects are mostly local, with grade 3 or higher treatment-related events in only 3%. ImmunityBio is expanding into BCG-naive disease and papillary-only cohorts. The idea is to make BCG work again by giving the immune cells it recruits a stronger signal.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Nogapendekin_alfa_inbakicept","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Nogapendekin%20alfa%20inbakicept"},{"label":"QUILT-3.032 (NEJM Evidence 2023)","url":"https://doi.org/10.1056/EVIDoa2200167"}],"tags":[],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["cytokine-therapy","bcg-and-intravesical-therapy"],"targets":[],"drugs":[],"companies":["immunitybio"],"institutions":[],"pathways":[],"terms":["bcg-unresponsive"],"trials":["quilt-3-032","nct06710288","nct03228667","nct06061809","nct06745908","nct04390399"],"people":[],"bottlenecks":[],"keyPapers":["paper-chamie-nejm-evid"],"journals":[],"dependsOn":[],"notes":[],"brand":"Anktiva","code":"N-803","modality":"IL-15 superagonist (intravesical, with BCG)","mechanism":"IL-15/IL-15Rα-Fc fusion that expands NK and memory CD8 T cells without preferentially stimulating regulatory T cells.","approvals":[{"region":"US","year":2024,"indication":"BCG-unresponsive NMIBC with CIS ± papillary tumours, with BCG"},{"region":"EU","year":2026,"indication":"BCG-unresponsive NMIBC with CIS, with BCG; 16 Feb 2026 (conditional)","note":"Conditional marketing authorisation"}],"mechanismSteps":["Co-instilled with BCG","IL-15 receptor signalling expands NK and CD8 T cells in the bladder wall","BCG provides antigen and danger signals; N-803 amplifies the effector response","Durable clearance of CIS with bladder preservation"],"dosing":{"route":"Intravesical with BCG","schedule":"400 µg with BCG weekly ×6, re-induction if needed, then maintenance at months 4, 7, 10, 13, 19 (and up to 37)"},"toxicity":[{"event":"Dysuria","anyGradePct":22},{"event":"Haematuria","anyGradePct":17},{"event":"Urinary frequency","anyGradePct":15},{"event":"Grade 3+ treatment-related","grade3PlusPct":3}],"access":[],"regulatoryEvents":[]},"route":"/drugs/nogapendekin-alfa/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"non-muscle-invasive-bladder-cancer","kind":"cancer","name":"Non-muscle-invasive bladder cancer","route":"/cancers/non-muscle-invasive-bladder-cancer/"}],"technology":[{"id":"cytokine-therapy","kind":"technology","name":"Cytokines & engineered cytokines","route":"/technologies/cytokine-therapy/"},{"id":"bcg-and-intravesical-therapy","kind":"technology","name":"Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)","route":"/technologies/bcg-and-intravesical-therapy/"}],"company":[{"id":"immunitybio","kind":"company","name":"ImmunityBio","route":"/companies/immunitybio/"}],"term":[{"id":"bcg-unresponsive","kind":"term","name":"BCG-unresponsive","route":"/terms/bcg-unresponsive/"}],"trial":[{"id":"nct06710288","kind":"trial","name":"A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In P","route":"/trials/nct06710288/"},{"id":"nct02138734","kind":"trial","name":"A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer","route":"/trials/nct02138734/"},{"id":"nct06745908","kind":"trial","name":"Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In","route":"/trials/nct06745908/"},{"id":"nct04390399","kind":"trial","name":"Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer","route":"/trials/nct04390399/"},{"id":"nct07355205","kind":"trial","name":"First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer","route":"/trials/nct07355205/"},{"id":"nct06061809","kind":"trial","name":"N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma","route":"/trials/nct06061809/"},{"id":"nct06149481","kind":"trial","name":"Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Can","route":"/trials/nct06149481/"},{"id":"quilt-3-032","kind":"trial","name":"QUILT 3.032","route":"/trials/quilt-3-032/"},{"id":"nct03228667","kind":"trial","name":"QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors","route":"/trials/nct03228667/"}],"paper":[{"id":"paper-chamie-nejm-evid","kind":"paper","name":"IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer","route":"/key-papers/paper-chamie-nejm-evid/"}],"idea":[{"id":"idea-bio2-nk-cells-for-mrd","kind":"idea","name":"Off-the-shelf natural killer cells to sweep up residual disease","route":"/ideas/idea-bio2-nk-cells-for-mrd/"}],"pathway":[{"id":"nk-cell-recognition","kind":"pathway","name":"NK-cell recognition: missing self & stress ligands","route":"/pathways/nk-cell-recognition/"},{"id":"t-cell-exhaustion","kind":"pathway","name":"T-cell exhaustion","route":"/pathways/t-cell-exhaustion/"}],"drug":[{"id":"valrubicin","kind":"drug","name":"Valrubicin","route":"/drugs/valrubicin/"}]}}