Anktiva Approved for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer – Renal and Urology News

The Food and Drug Administration (FDA) has approved Anktiva^® (nogapendekin alfa inbakicept-pmln) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Nogapendekin alfa inbakicept-pmln is an interleukin-15 receptor agonist. Binding of nogapendekin alfa inbakicept-pmln to its receptor results in proliferation and activation of natural killer, CD8+, and memory T cells. 

“This novel mechanism of action, which mimics the biology of the dendritic cell, begins the evolution of immunotherapy beyond T cells alone,” said Patrick Soon-Shiong, MD, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “The combination of the proliferation of key cancer-killing immune cells, together with the activation of T cells with memory, results in durable complete responses.”

The approval was based on data from the phase 2/3, open-label QUILT-3.032 study (ClinicalTrials.gov Identifier: NCT03022825), which included 77 patients with BCG-unresponsive, high-risk, NMIBC with CIS with or without Ta/T1 papillary disease following transurethral resection.

Study participants (median age, 73 years; 86% male; 90% White) received nogapendekin alfa inbakicept-pmln administered intravesically with BCG during the induction period followed by maintenance therapy for up to 37 months. The major efficacy outcomes were complete response (defined by negative results for cystoscopy and urine cytology) and duration of response.

Findings showed 62% (95% CI, 51-73) of patients achieved a complete response. The duration of response ranged from 0 to 47.0+ months; 58% (n=28) of patients with complete response had responses lasting at least 12 months and 40% (n=19) had responses lasting at least 24 months.

The most common adverse reactions reported with treatment were increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.

Anktiva is supplied as a 400mcg/0.4mL solution in single-dose vials for intravesical instillation after dilution. According to the Company, the product is expected to be available by mid-May 2024.

This article originally appeared on MPR