NewsFlash – Anktiva Approved to Treat Bladder Cancer

ImmunityBio was granted U.S. Food and Drug Administration (FDA) approval on April 22, 2024, for Anktiva^® (nogapendekin alfa inbakicept-pmln) solution. The first interleukin-15 (IL-15) receptor agonist, it is indicated to treat non-muscle invasive bladder cancer (NMIBC) associated with carcinoma in situ (CIS), whether or not papillary tumors are present. The cancer must be resistant to therapy with the standard of care, Bacillus Calmette-Guérin (BCG). An immunotherapy that will be used along with BCG, Anktiva promotes the activity of immune cells to destroy cancer cells. The recommended induction dose is 400mcg intravesically (introduced into the bladder through a catheter) once every week for six weeks. As maintenance therapy, doses switch to 400mcg once a week for three weeks in the fourth, seventh, tenth, thirteenth, and nineteenth months. Patients in complete response (CR) then continue the once-a-week-for-three-weeks regimen in months 25, 31, and 37. The solution should remain inside the bladder for two hours after each treatment. The launch is planned for the middle of May 2024, but the cost has not yet been announced. Prescribing information for Anktiva can be found here.

At a Glance

• Brand (Generic) Name: Anktiva (nogapendekin alfa inbakicept-pmln)
• Manufacturer: ImmunityBio
• Date Approved: April 22, 2024
• Indication: with BCG for the treatment of adults who have BCG-unresponsive NMIBC with CIS and either with or without papillary tumors
• Dosage Forms Available: single-dose vials containing 400mcg of solution for dilution and intravesical instillation
• Launch Date: mid-May 2024
• Estimated Cost: Not yet available
• The American Cancer Society (ACS) estimates that about 83,000 new cases of bladder cancer are discovered in the U.S. each year, with roughly eight out of ten being NMIBC. Affecting only the urothelial cell lining of the bladder, NMIBC has not yet penetrated into the bladder’s muscles.
• The five-year survival rate for CIS of the bladder is high at 96%, dropping to 70% if cancer has spread to other parts of the bladder and to 38% if lymph nodes and other body parts outside of the bladder are involved.
• The current first-line treatment for NMIBC is BCG, a bacterium that causes inflammation inside the bladder, prompting a T-cell reaction. Cancer responds to BCG for up to 60% of patients, but approximately one-half of responders will relapse.
• Anktiva accelerates the production and actions of immune cells, specifically natural killer (NK) cells, CD8+ cells, and killer T-cells.
• Of 77 patients in one arm of a clinical trial for Anktiva plus BCG, 48 experienced CRs with an average duration of nearly four years at the time the study results were reported. Participants were treated actively for as long as 37 months.
• The most frequent side effects among study participants included fever, muscle and bone pain, urinary urgency, and urinary tract infections (UTIs). Blood levels of creatinine and/or potassium were elevated for some participants, as well.
• A gene therapy, Adstiladrin^® (nadofaragene firadenovec-vncg – Ferring Pharmaceuticals) suspension, was FDA approved in December 2022, for the same indication as Anktiva. Given as one intravesical instillation every three months, it uses an adenovirus vector to insert copies of a human interferon-alfa 2b (IFNα2b) gene into the cells of the bladder greatly increasing the body’s immune response.
• Other current options for BCG-resistant NMIBC at high risk of recurrence and progression to invasive cancer include removal of the bladder (cystectomy) and surrounding tissues, chemotherapy (chemo), or treatment with Keytruda^® (pembrolizumab – Merck) injection.
• In addition to being designated as a Breakthrough Therapy, Anktiva was approved with an FDA Assessment Aid, an abbreviated review of the main information about the drug and its development submitted to expedite the review process.