The immunotherapy, nogapendekin alfa inbakicept (Anktiva), has demonstrated sustained effectiveness for patients with high-risk bladder cancer that no longer responds to standard Bacillus Calmette-Guérin (BCG) therapy. Updated results from the phase 2/3 QUILT-3.032 trial, presented at the 2025 American Urological Association Annual Meeting, highlight its potential to spare patients from invasive surgery while maintaining strong survival outcomes.
Key Findings for Patients
- 71% Complete Response Rate: Over two-thirds of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) and carcinoma in situ (CIS) achieved complete remission, with 60% maintaining this response for at least 12 months.
- 84% Avoided Bladder Removal: At 36 months, 84% of responders retained their bladder, offering a critical quality-of-life benefit.
- 99% Disease-Specific Survival: Nearly all patients survived without cancer-related complications at the three-year mark.
Safety and Tolerability
The treatment combination of nogapendekin alfa inbakicept and BCG was well-tolerated, with most side effects being mild (e.g., urinary discomfort, frequent urination). Severe adverse events were rare (3% of patients), and no life-threatening complications were reported.
About Nogapendekin Alfa Inbakicept
The new immunotherapy Anktiva is thought to work by activating your body’s own natural killer (NK) cells and killer T cells, which are important parts of your immune system that help find and destroy cancer cells. This treatment also stimulates memory T cells, which can “remember” how to fight cancer, leading to long-lasting results.
What This Means for Patients
Approved by the FDA in April 2024, this therapy provides a new bladder-preserving option for those who previously faced limited choices after BCG failure.
Ongoing studies continue to explore its use in other BCG-unresponsive NMIBC subtypes, with early data suggesting strong results for papillary disease without CIS. Patients are encouraged to discuss this option with their care teams to determine eligibility.
More Reading
Bladder Cancer Overview
FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer
Join the conversation on CancerConnect!
References
Chang S, Chamie K, Kramolowsky E, et al. An updated on QUILT-3.032: complete responses to N-803 plus BCG therapy in BCG-unresponsive bladder carcinoma in situ (CIS) with or without papillary disease. Presented at: American Urological Association Annual Meeting; April 26-29, 2025; Las Vegas, NV. Abstract PD12-12.
FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. FDA. 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
