FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer
Regulatory approval: On April 22, 2024, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva) 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. Approval was supported by the single-arm QUILT-3.032 trial (n=77), which reported a complete response (CR) rate of 62% (95% CI, 51–73) and durable responses in a subset of responders.
FDA approval (April 22, 2024)
The FDA approved nogapendekin alfa inbakicept-pmln (Anktiva; Altor BioScience, LLC) with BCG for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
Evidence base
Efficacy and safety were evaluated in QUILT-3.032 (NCT0302285), a single-arm, multicenter trial enrolling 77 patients with BCG-unresponsive, high-risk NMIBC with CIS with or without Ta/T1 papillary disease after transurethral resection. Patients received intravesical nogapendekin alfa inbakicept-pmln with BCG induction, followed by maintenance for up to 37 months.
Tumor status was assessed by cystoscopy and urine cytology every 3 months for up to 2 years; biopsy within the first 6 months was required, with subsequent assessments per local standards.
Primary efficacy outcomes were complete response (CR) at any time and duration of response (DOR). CR rate: 62% (95% CI, 51–73). Among patients with CR, 58% had DOR ≥12 months and 40% had DOR ≥24 months.
Safety
Most common adverse reactions (≥15%), including lab abnormalities: increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, pyrexia.
The application received breakthrough designation and used the FDA Assessment Aid process.