ImmunityBio, Inc. (Nasdaq: IBRX), the California-based immunotherapy company, announced on October 16, 2026, the peer-reviewed publication of extended findings from its QUILT-3.032 clinical study of ANKTIVA (nogapendekin alfa inbakicept-pmln) combined with Bacillus Calmette-Guérin in patients with BCG-unresponsive non-muscle-invasive bladder cancer. The analysis, published in the Journal of Urology, included 100 patients with carcinoma in situ, with or without accompanying papillary tumors, and reported a 71% complete response rate. Median duration of complete response reached 26.6 months, with individual responses extending beyond 53 months.
Among the 71 patients who achieved complete responses, the estimated cystectomy-free survival rate at 36 months was 84.2%, suggesting that many responders were able to retain their bladders during extended follow-up. The study also reported disease-specific survival of 98.2% at three years and an estimated progression-free survival rate of 80.9%. Most treatment-related adverse events were mild or moderate, while Grade 3 treatment-related events occurred in approximately 4% of patients and no Grade 4 or Grade 5 treatment-related events were reported.
The long-term evidence arrives just two days after the FDA expanded ANKTIVA’s approved indication to include eligible patients with BCG-unresponsive high-grade papillary-only disease. However, the newly published 100-patient analysis concerns the original carcinoma in situ population, not a new pivotal study in papillary-only patients. The regulatory expansion relied on existing evidence and the scientific relationship between those disease presentations, making it important to distinguish the clinical populations when interpreting the latest results.
The publication strengthens understanding of response durability with an already approved treatment but does not establish comparative superiority over other bladder-preserving approaches. QUILT-3.032 was a single-arm study without a randomized concurrent control group, and its most favorable bladder preservation statistic applies specifically to patients who responded. The practical question is how reliably those long-term outcomes can be reproduced in routine care while ensuring that patients with persistent or progressive cancer do not delay necessary surgery.
What does the 71% complete response rate establish in the expanded 100-patient analysis?
The latest analysis includes all 100 patients enrolled in the carcinoma in situ cohort of QUILT-3.032, a multicenter Phase 2/3 investigation registered as NCT03022825. All patients had BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without associated Ta or T1 papillary disease. They received intravesical ANKTIVA together with BCG according to the investigational treatment schedule.
The complete response rate was 71%, meaning 71 of the 100 patients met the study’s criteria for disappearance of detectable qualifying disease at the relevant assessments. The reported 95% confidence interval ranged from 61.1% to 79.6%, reflecting uncertainty around the estimated response rate. The findings provide evidence of substantial treatment activity in a difficult population whose disease had not responded adequately to previous BCG therapy.
However, complete response is not equivalent to permanent cure. Patients can experience recurrence after an initial response, while some may develop more invasive disease despite treatment. Continued cystoscopic surveillance, urine assessment and other appropriate investigations remain necessary.
The new analysis also differs from the original FDA-reviewed efficacy population of 77 patients. That earlier population supported the April 2024 authorization and demonstrated a 62% complete response rate. The difference between 62% and 71% reflects analyses of different patient populations and follow-up datasets, not proof that the medicine’s effectiveness increased over time.
For clinical interpretation, the broader 100-patient analysis provides additional information about response and follow-up. The original 77-patient regulatory dataset remains relevant because the FDA evaluated that defined population when establishing the initial approval.
How durable were complete responses after ANKTIVA plus BCG treatment?
The median duration of complete response in the updated 100-patient analysis was 26.6 months. Individual response durations ranged from approximately 0.03 months to 53.6 months, demonstrating considerable variation between patients. The longest responses therefore extended beyond four years, although the maximum observed duration should not be treated as the expected outcome for every patient.
Among responders, 63.8% maintained complete response for at least 12 months and 52.3% for at least 24 months. At 36 months, the corresponding proportion was 44.2%. These figures describe the durability of response among patients who initially responded, rather than the proportion of the entire treated population remaining disease-free.
The study also included particularly long follow-up in the original FDA-reviewed population. ImmunityBio reported that more than half of responding patients in that subset maintained complete responses beyond 45 months. This observation supports the possibility of prolonged disease control but involves a selected group with longer available follow-up.
Duration of response matters because patients receiving bladder-preserving treatment generally want to avoid repeated recurrence and further invasive procedures. A response lasting several years may provide substantially greater clinical value than an initial response followed by rapid recurrence. Nevertheless, response duration alone cannot establish that ANKTIVA provides superior long-term outcomes compared with other therapies.
The study’s extended observation period is therefore a strength, while its uncontrolled design remains a limitation. The results provide useful information about what happened to treated patients but cannot directly establish what would have occurred had they received a different treatment.
Why does the 84.2% cystectomy-free survival figure require careful interpretation?
Cystectomy is surgery to remove the bladder and may be recommended for patients with high-risk non-muscle-invasive bladder cancer that fails to respond adequately to treatment. Although surgery can provide important cancer control, it has substantial consequences for urinary function, recovery and quality of life. Avoiding or delaying cystectomy without compromising cancer outcomes is therefore a meaningful treatment objective.
In the newly published analysis, Kaplan-Meier estimated cystectomy-free survival among the 71 complete responders was 90.3% at 24 months and 84.2% at 36 months. The three-year estimate had a 95% confidence interval of 69.6% to 92.1%. These findings indicate that most patients who achieved complete response remained free from bladder removal at those estimated time points.
The central qualification is the denominator. The analysis concerns 71 responders rather than all 100 enrolled patients. It would therefore be incorrect to state that 84.2% of everyone treated with ANKTIVA avoided cystectomy at three years based on this result.
There is also a distinction between cystectomy-free survival and cancer-free survival. A patient may retain their bladder despite experiencing recurrent disease, and some patients may be unable or unwilling to undergo surgery for reasons unrelated to treatment efficacy. The absence of cystectomy does not automatically demonstrate that a patient remains cancer-free.
The result also cannot establish that ANKTIVA reduced the risk of surgery compared with standard treatment because the study lacked a randomized control arm. Nevertheless, the estimate provides clinically relevant information about long-term bladder preservation among patients achieving a response.
What do the three-year survival and progression findings suggest?
The publication reported an estimated disease-specific survival rate of 98.2% at 36 months. This measure concerns survival without death attributed to bladder cancer rather than survival from all possible causes. It is therefore distinct from overall survival, particularly in a population that may include older adults and patients with other medical conditions.
Progression-free survival was reported at 80.9% after three years. In the context of this disease, progression to muscle-invasive cancer is particularly important because it can change treatment options and prognosis substantially. ImmunityBio also reported that approximately 4% of complete responders progressed to muscle-invasive disease.
These findings suggest that many patients maintained meaningful disease control during extended follow-up. However, the estimates must be interpreted according to the study’s endpoint definitions, surveillance programme and the number of patients remaining under observation at each time point. Long-term Kaplan-Meier estimates can become less precise as participants are censored or reach different follow-up durations.
The relatively favorable disease-specific survival figure does not establish that ANKTIVA prolongs life compared with every alternative treatment. That would require an appropriate comparison accounting for disease characteristics, surgery, previous treatment and other factors influencing survival.
The results are nonetheless relevant to discussions about bladder preservation. Clinicians and patients must balance the possibility of maintaining the bladder against the risk that a cancer may recur or progress while further intravesical therapy is attempted.
What did the longer follow-up reveal about ANKTIVA’s safety?
The updated QUILT-3.032 analysis reported that treatment-related adverse events were predominantly Grade 1 or Grade 2. These commonly involved localized urinary symptoms associated with intravesical administration. Grade 3 treatment-related adverse events occurred in approximately 4% of the studied population, with no Grade 4 or Grade 5 treatment-related adverse events identified.
Intravesical treatment involves delivering medicine directly into the bladder through a catheter. Common clinical concerns can include urinary frequency, discomfort, irritation, blood in the urine and symptoms associated with local inflammation. The use of BCG adds its own established safety considerations, including the possibility of infection-related and immune-mediated complications.
The absence of reported Grade 4 or Grade 5 treatment-related events in the study is encouraging but does not mean the treatment is risk-free. The number of enrolled patients limits the ability to identify very uncommon complications, while adverse-event attribution can be difficult when a combination therapy is administered to patients with active bladder disease.
One of the most consequential safety considerations is the possibility of delaying cystectomy when the cancer is not adequately controlled. The FDA warns that postponing necessary surgery may allow progression to muscle-invasive or metastatic bladder cancer, which can be life-threatening. Patients who fail to achieve an appropriate response require reassessment of their treatment strategy.
Long-term tolerability therefore forms only one part of the overall benefit-risk evaluation. Safe bladder preservation also requires accurate detection of recurrence, appropriate clinical surveillance and timely intervention when the disease progresses.
How does the new publication relate to ANKTIVA’s expanded FDA indication?
The FDA initially approved ANKTIVA with BCG in April 2024 for adults with BCG-unresponsive non-muscle-invasive bladder cancer involving carcinoma in situ, with or without papillary tumors. On October 14, 2026, the agency expanded the indication to include eligible patients with high-grade papillary-only disease. The decision broadened the range of patients who could receive the approved combination.
The expansion is scientifically important because carcinoma in situ and papillary-only disease differ in appearance and in the ways treatment response is assessed. Flat CIS lesions are often evaluated using complete response criteria, while papillary tumors are commonly removed through transurethral resection before subsequent treatment and surveillance. These differences affect how clinical endpoints should be interpreted.
The FDA considered evidence from the original CIS study alongside clinical and biological similarities between the two high-grade disease presentations. It determined that extrapolating the existing efficacy evidence was appropriate for the expanded population. The decision did not depend on a new randomized pivotal trial demonstrating the same 71% complete response rate in papillary-only patients.
The October 16 publication is therefore most directly relevant to the original CIS-associated indication. It provides stronger long-term follow-up in that population and supports understanding of the treatment’s durability. It should not be presented as newly generated three-year efficacy evidence from a papillary-only cohort.
This distinction is important because the commercial expansion and the long-term publication occurred in the same week. They are separate developments with related but different evidentiary foundations.
How could the long-term results affect ImmunityBio’s commercial position?
ImmunityBio is already commercializing ANKTIVA in the United States and has reported growing demand. Second-quarter 2026 net product revenue reached $50.7 million, increasing 92% from the corresponding period in 2025. First-half net product revenue totaled approximately $94.8 million.
The broader FDA indication may increase the number of eligible patients, while longer-term follow-up can provide additional information for physicians evaluating bladder-preserving treatment options. However, neither development guarantees that prescriptions or reimbursement will increase by a specific amount. Actual uptake will depend on patient eligibility, BCG availability, treatment-center capacity and the clinical alternatives considered appropriate.
Competition in BCG-unresponsive disease is also evolving. Available treatments include other bladder-preserving therapies with different mechanisms, administration schedules and evidence bases. Direct comparisons are difficult because studies may enroll different populations, define endpoints differently and have varying follow-up periods.
ImmunityBio has previously published indirect comparisons with selected competing therapies, but those analyses are not substitutes for randomized head-to-head trials. The current long-term publication therefore strengthens the evidence supporting ANKTIVA without establishing an uncontested ranking among available treatments.
Another operational consideration is the need for continued BCG supply because ANKTIVA’s approved regimen requires coadministration. Commercial scale depends on reliable access to both treatment components and appropriate facilities for repeated bladder instillation.
What questions remain after the longest QUILT-3.032 follow-up?
The latest findings provide more extensive evidence of response durability and bladder preservation than the earlier regulatory dataset. However, important questions remain concerning outcomes in routine practice, including patients with different medical histories, disease characteristics and capacity to complete prolonged maintenance treatment.
It will also be important to understand how response durability varies between patients whose disease never responded to previous BCG and those who initially responded before recurring. The study reported a 66% complete response rate among BCG-refractory patients, suggesting activity in a difficult subgroup. Nevertheless, subgroup findings require careful interpretation because patient numbers and other characteristics may influence response estimates.
Future research may also examine predictors of sustained response, the practical effects of maintenance therapy and the relationship between treatment outcomes and quality of life. Avoiding bladder removal can be valuable, but patients may still experience repeated procedures, urinary symptoms and the psychological burden of surveillance.
The October publication provides a substantial body of follow-up for an already approved immunotherapy. Its central result is not simply that ANKTIVA produced complete responses, but that a meaningful proportion of those responses persisted for years, allowing many responders to retain their bladders.
The findings support the role of ANKTIVA plus BCG as a bladder-preserving option for selected patients with BCG-unresponsive disease, provided surveillance and appropriate surgical decision-making remain central to care. The strongest conclusion concerns sustained activity within the treated cohort; comparative superiority and the generalizability of the responder-specific 84.2% cystectomy-free survival estimate remain important limits.
