Nogapendekin Alfa/BCG Shows 84% Cystectomy-Free Survival at 3 Years

Long-term data from the phase 2/3 QUILT-3.032 trial (NCT03022825) showed that nogapendekin alfa inbakicept-pmln (Anktiva) in combination with Bacillus Calmette-Guérin (BCG) produced durable complete responses and high rates of bladder preservation in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease, according to a news release from the developer, ImmunityBio.¹

The analysis included 100 patients and represents one of the longest follow-up datasets reported in this disease setting, with outcomes extending beyond 5 years in some patients. The nogapendekin alfa inbakicept-based combination received an initial FDA approval for BCG-unresponsive NMIBC with CIS in April 2024, as well as a label expansion to include BCG-unresponsive NMIBC with high-grade papillary-only tumors in October 2026.^2,3

What were the key efficacy findings from the long-term QUILT-3.032 analysis?

Among 100 evaluable patients, the CR rate was 71%, consistent with the 71.0% (95% CI, 59.6%–80.3%) CR rate reported in Cohort A at the time of the original approval and previously published in NEJM Evidence.⁴ The median duration of CR was 26.6 months (95% CI, 9.9 months–not reached [NR]), extending beyond 53 months in some patients. More than half of responding patients in the FDA-reviewed population maintained a CR beyond 45 months. The cystectomy-free survival at 36 months was 84% among responders.

At 3 years, the disease-specific survival was 98.2%, and the progression-free survival was 80.9%. The rate of progression to muscle-invasive disease was 4% among responders. Among the subgroup of patients with BCG-refractory disease, the CR rate was 66%.

"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 [nogapendekin alfa inbakicept’s] unique mechanism of action in generating sustained immune responses," Patrick Soon-Shiong, MD, founder, executive chairman, and global chief scientific and medical officer of ImmunityBio, stated in the news release.¹ "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."

How durable were complete responses across key time points?

Among all patients who achieved a CR, 63.8% maintained a response for at least 12 months, 52.3% for at least 24 months, and 44.2% for at least 36 months. The CR rates were 55.0%, 56.0%, and 45.0% at the 3-, 6-, and 12-month assessment windows in Cohort A at the time of the original 2024 approval.

"Achieving a durable response and avoiding cystectomy are important treatment goals for patients with BCG-unresponsive NMIBC," stated Richard Adcock, president and CEO of ImmunityBio, in the press release.¹ "These peer-reviewed results add to the growing body of evidence supporting [nogapendekin alfa inbakicept] plus BCG and highlight its potential to provide sustained disease control and meaningful cystectomy avoidance for patients with limited treatment options."

What efficacy supported the October 2026 label expansion to papillary-only disease?

The October 2026 FDA label expansion extended the indication to patients with BCG-unresponsive high-grade papillary-only tumors (patients without concurrent CIS) based on extrapolation from the established CIS efficacy data rather than a dedicated prospective trial in this subset. The FDA found overlapping clinical and nonclinical features between high-grade papillary and CIS disease in the BCG-unresponsive setting, including frequent coexistence, shared risk of recurrence and progression, and common difficulty distinguishing the 2 histologic subtypes pathologically.

In QUILT-3.032 Cohort B, which enrolled 77 patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC, the estimated 12-month disease-free survival (DFS) rate was 55.4% (95% CI, 42.0%–66.8%), with 18-month and 24-month DFS rates of 51.1% (95% CI, 37.6%-63.1%), and 48.3% (95% CI, 34.5%-60.7%), respectively. The median DFS in Cohort B was 19.3 months (95% CI, 7.4 months–NR).

What is the safety profile of nogapendekin alfa inbakicept plus BCG?

The long-term safety profile of the regimen remained favorable as of the most recent follow-up. Grade 3 treatment-related adverse events occurred in 4% of patients in the current analysis, with no grade 4 or grade 5 events reported. In the original approval dataset, the most common treatment-emergent adverse effects were dysuria, pollakiuria, and hematuria, with 86% of patients in Cohorts A and B experiencing at least one grade 1/2 event.

The most common adverse reactions occurring in at least 15% of patients per the current prescribing information include increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.

References

1. 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://tinyurl.com/3d9etwrv
2. FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. News release. FDA. April 22, 2024. Accessed October 16, 2026. https://shorturl.at/boswH
3. FDA approves expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. News release. FDA. October 14, 2026. Accessed October 16, 2026. https://tinyurl.com/38cp583x
4. 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). doi:10.1056/EVIDoa2200167