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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › IMMUNOSTIMULANTS › IMMUNOSTIMULANTS › Interleukins
nogapendekin alfa and inbakicept
L03AC03
Forms & Strengths
- Intravesical solution: 400 mcg/0.4 mL nogapendekin alfa inbakicept per vial, supplied with 10.4 mg/0.4 mL inbakicept co-formulated
Adult Dosing
- Intravesical instillation: 400 mcg administered into the urinary bladder once weekly for 6 weeks (Induction)
- Maintenance (if complete response achieved): Once weekly for 3 weeks at months 3, 6, 9, 12, and 15 (up to 3 years total)
Pediatric Dosing
- Safety and efficacy have not been established in pediatric patients
Indications
- Treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors
Mechanism of Action
- Nogapendekin alfa (IL-15 superagonist) binds to the IL-15 receptor beta/gamma subunits, stimulating proliferation and activation of natural killer (NK) cells and CD8+ T cells
- Inbakicept (IL-15Ra/Fc fusion protein) enhances the presentation and half-life of the IL-15 superagonist, augmenting anti-tumor cell-mediated immunity
Contraindications
- History of severe hypersensitivity to nogapendekin alfa inbakicept or any of its components
- Active urinary tract infection at the time of treatment
Adverse Reactions
- Dysuria
- Hematuria
- Micturition urgency
- Pollakiuria
- Urinary tract infection
- Musculoskeletal pain
- Chills
- Fatigue
- Fever
Drug Interactions
- No formal pharmacokinetic drug-interaction studies have been conducted
- Immunosuppressive agents may theoretically interfere with the pharmacodynamic activity of IL-15 receptor agonists
Curated Content: Needs Vetting Before Put to Clinical Use