Nogapendekin Alfa Inbakicept

Nogapendekin alfa inbakicept-pmln is an IL-15 receptor agonist. IL-15 signals through a heterotrimeric receptor that is composed of the common gamma chain (γc) subunit, the beta chain (βc) subunit, and the IL-15-specific alpha subunit, IL-15 receptor α.

• ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

• None None ( 4 )contraindicated

For Intravesical Use Only For induction: 400 mcg administered intravesically with BCG once a week for 6 weeks. A second induction course may be administered if complete response is not achieved at month 3. ( 2.1 ) For maintenance: 400 mcg administered intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13 and 19. For patients with an ongoing complete response at month 25 and later, additional maintenance instillations with BCG may be administered once a week for 3 weeks at months 25, 31, and 37. ( 2.1 ) Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours. ( 2.2 ) See full Prescribing Information for dilution and administration instructions. 2.1 Recommended Dosage For Intravesical Use Only. Do NOT administer by subcutaneous or intravenous or intramuscular routes. For induction: ANKTIVA is recommended at a dose of 400 mcg administered intravesically with BCG once a week for 6 weeks. A second induction course may be administered if complete response is not achieved at month 3. For maintenance: After BCG and ANKTIVA induction therapy, ANKTIVA is recommended at a dose of 400 mcg administered intravesically with BCG once a week for 3 weeks at months 4, 7, 10, 13 and 19 (for a total of 15 doses). For patients with an ongoing complete response at month 25 and later, maintenance instillations with BCG may be administered once a week for 3 weeks at months 25, 31, and 37 for a maximum of 9 additional instillations.

Delaying cystectomy can lead to the development of metastatic bladder cancer, which can be lethal. ( 5.1 ) 5.1 Risk of Metastatic Bladder Cancer with Delayed Cystectomy Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS. Of the 77 evaluable patients with BCG-unresponsive CIS treated with ANKTIVA with BCG in QUILT-3.032, 10% (n = 8) progressed to muscle invasive (T2 or greater) bladder cancer, including 7 during the treatment period. Three patients had progression determined at the time of cystectomy. The median time between determination of persistent or recurrent CIS and progression to muscle-invasive disease was 107 days (range: 0 – 210). If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc. at toll-free phone 877-265-8482 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ANKTIVA with BCG was evaluated in Cohort A of QUILT-3.032, a single-arm, multicenter clinical study in 88 patients with BCG-unresponsive high-grade NMIBC with CIS with or without Ta/T1 papillary disease [see Clinical Studies ( 14 )]. Patients received 400 mcg ANKTIVA with BCG weekly for 6 consecutive weeks during induction and then once a week for every 3 weeks at 4, 7, 10, 13, and 19 months for patients with no or low grade disease. Patients with persistent CIS or high grade Ta at 3 months were eligible to receive a second induction. Patients with ongoing CR at 25 months were eligible to receive additional instillations once a week every 3 weeks at months 25, 31, and 37. The median number of doses of ANKTIVA with BCG administered to patients was 12 (range 2 – 30) doses.

Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 8.1 , 8.3 ) 8.1 Pregnancy Risk Summary Systemic exposure of nogapendekin alfa inbakicept-pmln following intravesical administration of the approved dosage of ANKTIVA was below the limit of quantitation [see Clinical Pharmacology 12.3 )] . Based on its mechanism of action, ANKTIVA may cause fetal harm when administered to a pregnant woman if systemic exposure occurs [see Clinical Pharmacology ( 12.1 )] . There are no available data on ANKTIVA use in pregnant women to inform a drug-associated risk. Animal reproductive and developmental toxicity studies have not been conducted with nogapendekin alfa inbakicept-pmln. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary There are no data on the presence of nogapendekin alfa inbakicept-pmln in human milk, or the effects on the breastfed child, or on milk production.

Metabolism

Systemic exposure of nogapendekin alfa inbakicept-pmln was less than 100 pg/mL following the approved recommended dosage in all patients. This was below the lower limit of quantitation in all patients.

• Apr 22, 2024BLABLA761336Altor Bioscience, Llc, An Indirect Wholly-owned Su

1. 1Neutropenia1034%
2. 2Chills517%
3. 3Anaemia414%
4. 4Pyrexia414%
5. 5Nausea310%
6. 6Abdominal Distension26.9%
7. 7Abdominal Pain Lower26.9%
8. 8Bladder Pain26.9%
9. 9Burning Sensation26.9%
10. 10Cytology Abnormal26.9%
11. 11Dysuria26.9%
12. 12Urinary Tract Infection26.9%
13. 13Abdominal Discomfort13.4%
14. 14Arthralgia13.4%
15. 15Asthenia13.4%

The 10 most recently updated of 16 ClinicalTrials.gov registrations naming Nogapendekin Alfa Inbakicept as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Followed by De-Intensified Radiation Compared With Standard Chemoradiation
  Not yet recruiting · Phase 2 · Interventional · 70 enrolled · ImmunityBio, Inc.
  NCT07628062updated 2026-06-04
• Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome
  Active not recruiting · Phase 2 · Interventional · 186 enrolled · National Cancer Institute (NCI)
  NCT05419011updated 2026-05-27
• Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer
  Terminated · Phase 3 · Interventional · 102 enrolled · ImmunityBio, Inc.
  NCT03520686updated 2026-05-26
• First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
  Not yet recruiting · Phase 2 · Interventional · 26 enrolled · Washington University School of Medicine
  NCT07355205updated 2026-05-22
• A Study to Examine Anktiva for the Treatment of COVID-19.
  Recruiting · Phase 2 · Interventional · 40 enrolled · ImmunityBio, Inc.
  NCT07123727updated 2026-05-13
• A Study to Assess Anktiva in Patients With Long Covid-19.
  Recruiting · Phase 2 · Interventional · 20 enrolled · ImmunityBio, Inc.
  NCT07108036updated 2026-05-11
• NAI for Sepsis With Persistent Lymphopenia
  Not yet recruiting · Phase 2 · Interventional · 50 enrolled · ImmunityBio, Inc.
  NCT07578558updated 2026-05-11
• Study of Nogapendekin Alfa Inbakicept and iNKT Cells in Critically Ill Adults With Severe Community-Acquired Pneumonia
  Withdrawn · Phase 3 · Interventional · 0 enrolled · ImmunityBio, Inc.
  NCT07492875updated 2026-05-08
• Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS)
  Withdrawn · Phase 2 · Interventional · 0 enrolled · ImmunityBio, Inc.
  NCT07492888updated 2026-05-08
• N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy
  Recruiting · Early phase 1 · Interventional · 8 enrolled · Northwestern University
  NCT07261657updated 2026-05-05

Frequently asked questions

How does Nogapendekin Alfa Inbakicept work?

Nogapendekin alfa inbakicept-pmln is an IL-15 receptor agonist. IL-15 signals through a heterotrimeric receptor that is composed of the common gamma chain (γc) subunit, the beta chain (βc) subunit, and the IL-15-specific alpha subunit, IL-15 receptor α.

What is Nogapendekin Alfa Inbakicept used for?

According to FDA labeling, Nogapendekin Alfa Inbakicept carries indications including: ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Nogapendekin Alfa Inbakicept?

Nogapendekin Alfa Inbakicept is classified as Interleukins, Cytokine Receptor Superfamily Interactions, Increased Immunologic Activity.

What are the brand names for Nogapendekin Alfa Inbakicept?

Nogapendekin Alfa Inbakicept is marketed under brand names including Anktiva.

What are the contraindications for Nogapendekin Alfa Inbakicept?

Nogapendekin Alfa Inbakicept labeling lists contraindications including: None None ( 4 ). Always consult the full prescribing information and a clinician.