Anktiva plus BCG shows durable responses in BCG-unresponsive NMIBC

Long-term follow-up from the phase 2/3 QUILT-3.032 study (NCT03022825) have been published in the Journal of Urology, showing that nogapendekin alfa inbakicept-pmln (Anktiva; NAI) plus BCG was associated with a 71% complete response rate among patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease.¹

Nogapendekin alfa inbakicept received FDA approval in combination with for this patient population in April 2024. The agency granted an expanded approval to the combination in October 2026 to include patients with BCG-unresponsive NMIBC with papillary-only tumors.

“The QUILT-3.032 study represents one of the longest follow-up data sets in BCG-unresponsive NMIBC to date, and the results continue to support the durability of Anktiva’s unique mechanism of action in generating sustained immune responses,” said Patrick Soon-Shiong, MD, founder, executive chairman, and global chief scientific and medical officer of ImmunityBio, in a company press release.² “These long-term findings are encouraging, suggesting the potential for prolonged disease control and the possibility of avoiding or delaying radical cystectomy for some patients.”

Long-term outcomes from QUILT-3.032

The multicenter phase 2/3 QUILT-3.032 study evaluated nogapendekin alfa inbakicept in combination with BCG in 100 patients with BCG-unresponsive NMIBC and CIS, with or without papillary disease. Patients received 400 mcg of NAI with 50 mg of BCG through intravesical instillation weekly for 6 weeks. A second induction course could be administered if a complete response was not achieved at month 3.

The primary end point was complete response at any time during the study. Secondary end points included duration of complete response, progression-free survival (PFS), overall survival, disease-specific survival (DSS), and time to cystectomy.

The overall complete response rate was 71% (95% CI, 61.1 to 79.6), with a median response duration of 26.6 months (range, 0.03 to 53.62 months). Among responders, 63.8% maintained a complete response for at least 12 months, 52.3% for at least 24 months, and 44.2% for at least 36 months. The complete response rate among BCG-refractory patients was 66%.

Kaplan-Meier estimates of cystectomy-free survival among the 71 responders were 90.3% (95% CI, 79.7 to 95.6) at 24 months and 84.2% (95% CI, 69.6 to 92.1) at 36 months. DSS was 100% at 12 months and 98.2% (95% CI, 88.2 to 99.8) at 36 months.

At 3 years, PFS was 80.9%. Four percent of responders progressed to muscle-invasive disease.

Safety profile and treatment tolerability

Treatment-related adverse events were predominantly grade 1 or 2, occurring in 59% of patients. Grade 3 treatment-related adverse events occurred in 4% of patients, and no grade 4 or 5 treatment-related adverse events were reported. According to ImmunityBio, most treatment-related events were localized bladder symptoms associated with intravesical treatment.

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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. 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. October 16, 2026. Accessed October 16, 2026. https://immunitybio.com/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/