FDA Approves Nogapendekin Alfa Inbakicept for Patients With Bacillus Calmette-Guérin-Unresponsive Non-Muscle Invasive Bladder Cancer

On April 22, 2024, the US Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. This approval was based on results from the phase 3 QUILT-3.032 trial.

In this multicenter, single-arm trial, 77 patients with BCG-unresponsive, high-risk NMIBC, with or without T_a/T₁ papillary disease, who had undergone transurethral resection received 400 mcg of nogapendekin alfa inbakicept intravesically with BCG, followed by maintenance therapy for up to 37 months. Tumor status was assessed every 3 months for up to 2 years using cystoscopy and urine cytology and biopsy was required within the first 6 months of treatment initiation. The major efficacy end points included complete response (CR) rate, defined by a negative cystoscopy and urine cytology at any time, and duration of response (DOR).

At analysis, CR rate was 62%. Among patients who achieved CR, 58% had a DOR ≥12 months and 40% had a DOR ≥24 months. The most common adverse events occurring in ≥15% of patients, including laboratory test abnormalities, included increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. 

The recommended dose of nogapendekin alfa inbakicept is 400 mcg administered intravesically with BCG once weekly for 6 weeks as induction therapy. If CR is not achieved within 3 months, a second induction course may be administered. The recommended dose of maintenance therapy is 400 mcg of once weekly nogapendekin alfa inbakicept for 3 weeks (a total of 15 doses at months 4, 7, 10, 13, and 19). For patients with ongoing CR at months 25 or later, maintenance instillations with BCG may be administered once weekly for a duration of 3 weeks (9 additional instillations at months 25, 31, and 37). Treatment should continue until disease persistence after second induction, disease recurrence or progression, unacceptable toxicity, or a maximum treatment duration of 37 months.

Source: 

FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. Published online: April 22, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer