Anktiva

Anktiva is a cancer immunotherapy for types of bladder cancer that have not responded to treatment with BCG (Bacillus Calmette-Guérin) vaccine. When Anktiva is used with BCG vaccine it activates the immune system, including immune memory cells, to kill bladder cancer cells. This may help the patient to have a durable complete response. Anktiva (nogapendekin alfa inbakicept-pmln) is an IL-15 agonist.

Anktiva FDA approval was received on April 22, 2024, to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. It was developed by a company named ImmunityBio, and during its development phase, it was referred to as N-803.

Anktiva is given with BCG as an intravesical instillation, which is a liquid drug delivered into the bladder through a tube (catheter) from the urethra.

Interleukin-15 (IL-15) is a protein that plays an important role in the immune system by affecting the development, maintenance, and function of special cells called natural killer (NK) and killer T cells. Anktiva mechanism of action (MOA) is as a IL-15 superagonist complex that works by binding to IL-15 receptors on NK, CD4, and CD8 T cells to drive the generation of memory killer T cells that have specifically been trained to recognize the cancer cells.

Anktiva is given as an intravesical instillation, which is when a liquid drug is delivered into the bladder through a tube (catheter) from the urethra. This medicine is used together with BCG.

The medicine should stay in the bladder for 2 hours before it is voided.

By delaying removing the bladder (cystectomy) this may lead to the development of metastatic bladder cancer, which can be fatal.

This medicine can cause fetal harm. Due to this risk, females of reproductive potential should use effective contraception during treatment and for one week after the last dose.

Pregnancy

Tell your healthcare provider if you are planning a pregnancy, are pregnant, or become pregnant as this medicine may cause fetal harm. Females of reproductive potential should use effective contraception during treatment with Anktiva and for 1 week after the last dose.

Your healthcare provider will ask you to do a pregnancy test before starting treatment.

Breastfeeding

There are no information on the presences of Anktiva in breast milk or the effects on the breastfed child, or on milk production. Discuss with your healthcare provider the best way to feed your baby while on this medication.

The most common Anktiva side effects are painful urination, frequent urination, urinary urgency, blood in the urine, urinary tract infection, chills, fever, and muscle and joint pain. It may also affect laboratory test results, with an increase in creatinine and potassium. These side effects occur in 15% or more of patients in clinical trials.

Other clinically relevant side effects of Anktiva when given with BCG include tiredness (14%), nausea (14%), irritated bladder (11%), Diarrhea (9%), and needing to urinate at night (7%).

Serious Anktiva side effects that occurred in patients receiving this medicine together with BCG included bood in urine for 3.4% of patients and fatal cardiac arrest for 1.1% of patients.

Usual induction dose

Induction Dose: 400 mcg administered intravesically with BCG once a week for 6 weeks. If a complete response is not achieved at month 3, a second induction course may be administered.

Usual maintenance dose

Maintenance Dose: After the induction Anktiva and BCG dose. 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.

Length of Therapy: The recommended duration of treatment is until disease persistence after the second induction, disease recurrence or progression, unacceptable toxicity, or a maximum of 37 months.

Anktiva is available as 400 mcg/0.4 mL solution in single-dose vials for intravesical instillation after dilution.

Review the Anktiva Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

• Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not freeze.
• Do not shake.

Manufactured for: Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc., Culver City, CA 90232.

Manufactured by: AGC Biologics, 21511 23rd Dr. SE, Bothell, WA 98021