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Nogapendekin alfa inbakicept

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.

QUILT 3.032: CR 71% in BCG-unresponsive CIS; long bladder preservation in responders. FDA approval 22 April 2024 after a 2023 complete response letter. ImmunityBio; expanding into BCG-naive disease and papillary-only cohorts.

Schematic of the modality · IL-15 superagonist (intravesical, with BCG) · not a molecule; see the Cytokines & engineered cytokines page
Mechanism, step by step
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1.Co-instilled with BCG

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.
Brand / code
Anktiva · N-803
Dosing & schedule
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)
Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Intravesical, given with BCG in the urology clinic.

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. Plans require BCG-unresponsive NMIBC with carcinoma in situ.

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not appraisedSearch NICE
Notes
No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
NHS England
Not routinely funded

Sources: NICE search: nogapendekin alfa inbakicept. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2024BCG-unresponsive NMIBC with CIS ± papillary tumours, with BCG

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Dysuria
22%
Haematuria
17%
Urinary frequency
15%
Grade 3+ treatment-related
3%

Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
12 studies3 recruiting9 Phase 23 Phase 3
Search “Nogapendekin alfa inbakicept” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Nogapendekin alfa inbakicept
intervention: Nogapendekin alfa inbakicept
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Latest papers

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Literature trend36 papers in the last 12 months+38% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Nogapendekin alfa inbakicept" OR ABSTRACT:"Nogapendekin alfa inbakicept" OR TITLE:"Anktiva" OR ABSTRACT:"Anktiva" OR TITLE:"N-803" OR ABSTRACT:"N-803") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Nogapendekin alfa inbakicept, not a curated reading list.

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