# Nogapendekin alfa inbakicept

Source: https://onco.cc/drugs/nogapendekin-alfa/  
OnCo record `nogapendekin-alfa` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Also known as: ALT-803; NAI; nogapendekin-alfa-inbakicept
- 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: US 2024: BCG-unresponsive NMIBC with CIS ± papillary tumours, with BCG; EU 2026: BCG-unresponsive NMIBC with CIS, with BCG; 16 Feb 2026 (conditional)
- Dosing: Intravesical with BCG; 400 µg with BCG weekly ×6, re-induction if needed, then maintenance at months 4, 7, 10, 13, 19 (and up to 37)
- Toxicity (grade 3+): Grade 3+ treatment-related 3%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Nogapendekin_alfa_inbakicept
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Nogapendekin%20alfa%20inbakicept
- QUILT-3.032 (NEJM Evidence 2023): https://doi.org/10.1056/EVIDoa2200167

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Non-muscle-invasive bladder cancer](https://onco.cc/cancers/non-muscle-invasive-bladder-cancer/)
- technologies: [Cytokines & engineered cytokines](https://onco.cc/technologies/cytokine-therapy/), [Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)](https://onco.cc/technologies/bcg-and-intravesical-therapy/)
- companies: [ImmunityBio](https://onco.cc/companies/immunitybio/)
- terms: [BCG-unresponsive](https://onco.cc/terms/bcg-unresponsive/)
- trials: [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](https://onco.cc/trials/nct06710288/), [A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer](https://onco.cc/trials/nct02138734/), [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](https://onco.cc/trials/nct06745908/), [Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer](https://onco.cc/trials/nct04390399/), [First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer](https://onco.cc/trials/nct07355205/), [N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma](https://onco.cc/trials/nct06061809/), [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](https://onco.cc/trials/nct06149481/), [QUILT 3.032](https://onco.cc/trials/quilt-3-032/), [QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors](https://onco.cc/trials/nct03228667/)
- key papers: [IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer](https://onco.cc/key-papers/paper-chamie-nejm-evid/)
- ideas: [Off-the-shelf natural killer cells to sweep up residual disease](https://onco.cc/ideas/idea-bio2-nk-cells-for-mrd/)
- pathways: [NK-cell recognition: missing self & stress ligands](https://onco.cc/pathways/nk-cell-recognition/), [T-cell exhaustion](https://onco.cc/pathways/t-cell-exhaustion/)
- drugs: [Valrubicin](https://onco.cc/drugs/valrubicin/)

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