ImmunityBio has resubmitted a supplemental biologics license application to the U.S. Food and Drug Administration seeking approval for Nogapendekin alfa inbakicept-pmln (Anktiva) to treat patients with BCG-unresponsive, non-muscle-invasive bladder cancer who have papillary-only tumors. The FDA had previously issued a refusal-to-file letter in May 2025, but after a January 2026 meeting the agency requested updated efficacy and longer follow-up data rather than new clinical trials. Anktiva was already approved in 2024 for patients with non-muscle-invasive bladder cancer with carcinoma in situ, and the new application aims to expand its use to patients whose tumors are papillary only.
The resubmission is supported by data from the QUILT-3.032 trial involving 80 patients with high-grade papillary-only disease treated with Anktiva in combination with BCG. The study reported disease-free survival rates of 58.2% at 12 months, 52.1% at 24 months, and 38.2% at 36 months. Progression-free survival remained high, reaching 94.9% at one year, 88.7% at two years, and 83.1% at three years. Many patients were also able to avoid cystectomy, with bladder-preservation rates of 92.2% at one year, 87.9% at two years, and 81.8% at three years.
Safety findings showed the treatment was generally well tolerated. About 61% of patients experienced mild grade 1 or 2 side effects, while only 3% reported grade 3 or higher events. No grade 4 toxicities or treatment-related deaths were observed. Anktiva works as an IL-15 superagonist that stimulates immune cells such as natural killer cells and T cells to attack cancer, offering a potential bladder-preserving treatment option for patients whose disease no longer responds to BCG therapy.