ANKTIVA plus BCG achieved a 71% complete response rate in BCG-unresponsive bladder cancer, with an estimated 84.2% cystectomy-free rate at three years among responders.
Written By: Sravani Pamanji, PharmD
Reviewed By: Pharmacally Editorial Team
ImmunityBio reported long-term findings from the Phase 2/3 QUILT-3.032 study on October 16, 2026, evaluating ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. Published in The Journal of Urology, the results provide additional evidence on response durability and bladder preservation in this population.
Among 100 patients evaluated, 71% achieved a complete response (CR), with a median response duration of 26.6 months. Some responses persisted beyond 53 months. Among the 71 responders, the estimated cystectomy-free rate was 84.2% at three years, highlighting the potential for bladder preservation in patients who respond to treatment.
QUILT-3.032: Study Design and Response Durability
QUILT-3.032 (NCT03022825) evaluated nogapendekin alfa inbakicept (NAI, also known as N-803) plus BCG in patients with BCG-unresponsive NMIBC involving CIS, with or without papillary disease.
Participants received 400 mcg of NAI with 50 mg of BCG through intravesical instillation once weekly for six weeks. An optional reinduction course was available for patients who had not achieved a CR by Month 3. The primary endpoint was CR rate at any time during the study. Secondary endpoints included duration of CR, progression-free survival, overall survival, disease-specific survival and time to cystectomy.
The CR rate was 71% (95% confidence interval [CI], 61.1–79.6), and median CR duration was 26.6 months, with the observed range extending to 53.62 months. Overall, 44.2% of patients maintained a CR for at least 36 months.
Among patients with BCG-refractory disease, defined in the report as those who had never responded to BCG, the CR rate was 66%. These findings indicate that some patients can maintain responses for several years, although the overall response rate and response duration measure different aspects of treatment benefit.
Bladder Preservation and Long-Term Outcomes
Avoiding radical cystectomy, or surgical removal of the bladder, is an important treatment consideration for patients with BCG-unresponsive NMIBC. In the QUILT-3.032 responder subgroup, the estimated cystectomy-free rate was 90.3% at 24 months and 84.2% at 36 months.
These estimates apply to patients who achieved a CR, rather than the entire study population. They therefore describe outcomes among treatment responders and should not be interpreted as the probability of avoiding surgery for every patient starting ANKTIVA plus BCG.
Disease-specific survival was 100% at 12 months and 98.2% at 36 months. Progression-free survival was 80.9% at three years, while 4% of responders progressed to muscle-invasive disease. These outcomes provide additional context for assessing disease control beyond the initial response, while also showing that progression can occur despite treatment.
Safety and Tolerability
Treatment-related adverse events were predominantly Grade 1 or Grade 2, reported in 59% of patients. Grade 3 treatment-related adverse events occurred in 4%, and no Grade 4 or Grade 5 treatment-related adverse events were reported. The company described most treatment-related events as localized bladder symptoms associated with intravesical administration.
These findings support the reported tolerability profile in the study population. However, the absence of Grade 4 or Grade 5 treatment-related events should not be interpreted as evidence that serious adverse outcomes of any cause cannot occur.
Clinical Significance
ANKTIVA is an interleukin-15 (IL-15) receptor agonist that activates immune cells involved in antitumor responses. The October 2026 findings extend the evidence on its use with BCG in BCG-unresponsive NMIBC with CIS, with or without papillary disease.
The FDA expanded ANKTIVA plus BCG’s approved indication in October 2026 to include papillary-only disease. However, the long-term analysis discussed here specifically evaluated patients with CIS, with or without papillary tumors, and should not be interpreted as a direct assessment of outcomes in the papillary-only population.
The 71% CR rate, median response duration of 26.6 months and estimated 84.2% cystectomy-free rate at three years among responders suggest that some patients can achieve prolonged disease control while avoiding bladder removal. Nevertheless, these findings do not establish that all patients will respond or avoid surgery. Delaying cystectomy can carry a risk of progression to muscle-invasive or metastatic disease, making continued surveillance and timely reassessment essential.
Overall, QUILT-3.032 adds long-term evidence on response durability and bladder preservation with ANKTIVA plus BCG. The results support consideration of both response likelihood and durability, alongside progression risk, safety and the potential consequences of delaying surgery, when evaluating treatment options for this patient population.
References
ImmunityBio, Inc. ImmunityBio Reports Phase 3 Data Showing 84% Cystectomy Avoidance at Three Years and Complete Responses Beyond 53 Months with ANKTIVA Plus BCG in BCG-Unresponsive NMIBC With CIS, With or Without Papillary Tumors. October 16, 2026.
Chang SS, Chamie K, Seabury CA, et al. Durable Responses and Cystectomy Avoidance with Interleukin-15 Receptor Agonist NAI Plus Bacillus Calmette-Guérin in Bacillus Calmette-Guérin-Unresponsive Nonmuscle-Invasive Bladder Cancer with Carcinoma in Situ ± Papillary Disease. The Journal of Urology. 2026;216(5):663–675. doi:10.1097/JU.0000000000005198. PubMed.
QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients with BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer, ClinicalTrials.gov ID NCT03022825
About the Writer
Sravani Pamanji is a PharmD (LinkedIn) professional with experience in scientific writing, medical literature review, drug profile preparation, and clinical case documentation. She has contributed to scientific publication and presented at the 74th Indian Pharmaceutical Congress. Her training includes ICH GCP E6(R3), scientific research, and medication safety. She is passionate about evidence-based medical communication and accurate dissemination of clinical and pharmaceutical information.