Anktiva Plus BCG: 84% of Responders Cystectomy-Free at 3 Years

Among patients with bacillus Calmette-Guérin (BCG)–unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) who achieved a complete response (CR) with nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG, an estimated 84.2% remained cystectomy-free at 36 months, according to long-term results from cohort A of the phase 2/3 QUILT-3.032 trial published in The Journal of Urology. The CR rate at any time was 71%, but the share of all enrolled patients in CR fell to 16% at the 36-month assessment, a distinction that matters when nurses help patients set expectations for bladder-sparing therapy.

What did QUILT-3.032 cohort A evaluate?

QUILT-3.032 (NCT03022825) is an open-label, single-arm, multicenter registrational trial conducted at 32 US sites. Cohort A enrolled 100 patients with histologically confirmed BCG-unresponsive NMIBC CIS with or without high-grade Ta/T1 papillary disease. The median age was 73 years (range, 50-91), 87% of participants were male, 90% were White, and 83% had an ECOG performance status of 0. Forty-four percent had BCG-refractory disease and 56% had relapsed disease, and participants had undergone a median of 4 prior transurethral resections.

Patients received 400 mcg of nogapendekin alfa inbakicept-pmln with 50 mg of BCG by intravesical instillation weekly for 6 weeks. Those without a CR at month 3 could receive a second 6-week induction, and responders continued maintenance through month 36. The primary end point was CR at any time, assessed by biopsy, urine cytology, and cystoscopy. Secondary end points included duration of response (DOR), time to cystectomy, progression-free survival (PFS), disease-specific survival (DSS), and overall survival (OS). At the July 15, 2024, data cutoff, median follow-up was 25.7 months (range, 3.2-63.5).

Nogapendekin alfa inbakicept-pmln is an interleukin-15 (IL-15) receptor agonist that activates and expands natural killer cells and CD8-positive T cells without expanding immunosuppressive regulatory T cells. Initial cohort results were published in NEJM Evidence, and the US Food and Drug Administration (FDA) approved the combination in April 2024 for BCG-unresponsive NMIBC with CIS with or without papillary tumors on the basis of an interim population of 77 patients. On October 14, 2026, the agency expanded the indication to include high-grade papillary-only disease.

How durable were complete responses?

• CR at any time: 71% (95% CI, 61.1%-79.6%), including 80% of patients who responded to the first induction and 50% of those who needed reinduction
• Median DOR: 26.6 months (95% CI, 13.0-49.9; range, 0.03-53.62)
• Probability of remaining in CR: 63.8% at 12 months or longer, 52.3% at 24 months or longer, and 44.2% at 36 months or longer
• Proportion of all 100 patients in CR at the 12-, 24-, and 36-month assessments: 47%, 30%, and 16%, respectively

In the 77-patient population reviewed for FDA approval, which had a longer median follow-up of 29.27 months, the median DOR exceeded 45 months, and the Kaplan-Meier estimated probability of a DOR of 45 months or longer was 51% (95% CI, 32.9%-66.3%). Blinded central pathology review of 94 patients confirmed CR in 70, for a CR rate of 74%.

Responses were seen across subgroups. CR rates were 66% in BCG-refractory disease and 75% in relapsed disease, and 69%, 82%, and 67% in patients with CIS only, CIS plus Ta, and CIS plus T1 disease, respectively. Ten of 18 patients who had received more BCG after being classified as BCG-unresponsive achieved a CR (56%).

How many patients avoided cystectomy?

Among the 71 responders, Kaplan-Meier estimated outcomes at 12, 24, and 36 months were as follows:

• Cystectomy-free rate: 95.5%, 90.3%, and 84.2%
• DSS: 100%, 98.2%, and 98.2%
• PFS: 92.7%, 90.9%, and 80.9%
• OS: 95.7%, 92.3%, and 86.5%

Three of the 71 responders (4%) progressed to T2 or higher disease. In their reply to an accompanying editorial, the authors reported that progression to muscle-invasive or metastatic disease occurred in 10% of all 100 cohort A participants during follow-up.

What safety signals should nurses monitor?

In cohort A, grade 1 or 2 treatment-related adverse events (TRAEs) occurred in 59% of patients and grade 3 TRAEs in 4%, with no grade 4 or 5 TRAEs. Grade 3 hematuria, urinary tract infection, pain in extremity, and arthralgia each occurred in 1% of patients, and grade 3 myalgia in 2%. One patient had a grade 3 serious adverse event of hematuria that led to a treatment interruption; the event resolved and the patient completed all remaining treatments.

The most common TRAEs were those related to bladder instillation, including dysuria, pollakiuria, and hematuria, and the investigators found no evidence of systemic exposure to nogapendekin alfa inbakicept-pmln after intravesical administration.

Eppie Bass, APRN, a nurse practitioner in genitourinary surgical oncology at Moffitt Cancer Center in Tampa, Florida, told Oncology Nursing News that the regimen gives patients another route to bladder preservation. "I think it's great that there's another treatment option that patients can have with non-muscle invasive bladder cancer, trying to salvage their bladder," she said.

How can nurses keep patients on long maintenance schedules?

According to Bass, symptom management, rather than missed surveillance, is the main threat to adherence over a maintenance course that can run up to 3 years. "Usually they don't miss cystos because they want to make sure their bladders are good, but if you can't manage their side effects of treatment, they're not going to do the treatment," she said.

Because instillation-related symptoms can mimic infection, Bass described triage calls that start by screening for systemic signs. "If a nurse is really good about asking questions, she's going to ask, do you have any fever? Do you have any flank pain? Have you had any chills? Do you have any systemic signs of an infection?" she said.

When symptoms are limited to the bladder, nurses review fluid intake and dietary triggers. "We try to dive down to, are you drinking enough water? Are you drinking caffeine, alcohol, spicy foods, carbonation? These are all bladder irritants," Bass said. Patients with systemic symptoms are checked for urinary tract infection.

Bass also counsels patients to expect mild immune-related effects while recognizing when to call. "I feel cruddy, I feel kind of achy. That's your body's immune system kicking in versus I have such bad joint pain, I cannot move. I've had chills all night long. That's a reason to be more concerned," she said, adding that severe symptoms may prompt the team to hold the next treatment and check a white blood cell count.

How does this fit with other bladder-sparing options?

Radical cystectomy remains the definitive treatment for BCG-unresponsive NMIBC, but bladder-sparing therapies are used for patients who are unwilling or unable to undergo surgery. The investigators cited CR rates reported in separate trials of 41% for pembrolizumab, 51% for nadofaragene firadenovec, and 82% for the gemcitabine intravesical system TAR-200, although single-arm designs limit cross-trial comparisons.

What are the key takeaways for oncology nurses?

• Frame response rates accurately: 71% of patients achieved a CR, and 44.2% of responders were estimated to remain in CR for 36 months or longer, but 16% of all patients were in CR at the 36-month assessment.
• Reinforce surveillance: Responses were assessed every 3 months through month 24 and every 6 months thereafter, and the label warns that delaying cystectomy can lead to metastatic disease.
• Anticipate local bladder symptoms: Dysuria, urinary frequency, and hematuria were the most common TRAEs; grade 3 hematuria and urinary tract infection each occurred in 1% of patients.
• Triage systemic signs first: Ask about fever, flank pain, and chills before attributing urinary symptoms to treatment, and review fluids and bladder irritants such as caffeine and alcohol.
• Manage symptoms to support adherence: Unmanaged side effects can lead patients to stop maintenance; severe chills or joint pain may warrant holding treatment and further workup.
• Explain reinduction: Half of patients who needed a second induction achieved a CR, and cystectomy should be reconsidered in patients with CIS who do not respond after it.
• Plan for a long course: Maintenance continued through month 36, creating repeated instillation visits that affect travel, time, and caregiver burden.
• Support shared decision-making: Editorialists emphasized weighing the cumulative toll of intravesical therapy against bladder preservation when patients consider their options.

References

1. 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. J Urol. 2026;216(5):663-675. doi:10.1097/JU.0000000000005198
2. Chamie K, Chang SS, Kramolowsky E, et al. IL-15 superagonist NAI in BCG-unresponsive non-muscle-invasive bladder cancer. NEJM Evid. 2023;2(1):EVIDoa2200167. doi:10.1056/EVIDoa2200167
3. ONN Staff. FDA expands Anktiva approval to papillary-only BCG-unresponsive NMIBC. Oncology Nursing News. October 14, 2026. Accessed October 16, 2026. https://www.oncnursingnews.com/view/fda-expands-anktiva-approval-to-papillary-only-bcg-unresponsive-nmibc
4. 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. News release. ImmunityBio, Inc. October 16, 2026. Accessed October 16, 2026. https://www.businesswire.com/news/home/20261016061704/en/
5. Persily J, Murray K. Editorial comment. J Urol. 2026;216(5):672-673. doi:10.1097/JU.0000000000005212
6. Zhu A, Gabriel PE, Sfakianos JP. Editorial comment. J Urol. 2026;216(5):674.
7. Biese A. Anktiva for papillary NMIBC: what nurses need to know about the regimen. Oncology Nursing News. October 15, 2026. Accessed October 16, 2026. https://www.oncnursingnews.com/view/anktiva-for-papillary-nmibc-what-nurses-need-to-know-about-the-regimen
8. Bass E. Interview with: Biese A. Oncology Nursing News. October 15, 2026.