Supplemental Information Requested For Nogapendekin Alfa sBLA in NMIBC Type

The FDA requested additional information during a Type B End-of-Phase meeting to support the acceptance of a supplemental biologics license application (sBLA) for nogapendekin alfa inbakicept (Anktiva) plus Bacillus Calmette-Guérin (BCG) as a treatment for patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with papillary tumors, according to a news release from the developer ImmunityBio.¹

Moreover, the information requested does not pertain to the design or initiation of any new trials, and the developers plan to provide it in the next 30 days.

In their presentation of an overview of the clinical status of cohort B from the phase 2/3 QUILT-3.032 trial (NCT03022825), the developers shared long-term results among 80 patients in this papillary-only population, which were also published in The Journal of Urology.² As of the cutoff date of July 15, 2024, the median disease-free survival (DFS) was 25.3 months, with rates of 58.2% (95% CI, 46.6%-68.2%) at 12 months, 52.1% (95% CI, 40.3%-62.7%) at 24 months, and 38.2% (95% CI, 25.6%-50.6%) at 36 months.

Additionally, the median progression-free survival (PFS) among cohort B was not reached (NR; 95% CI, 46.5-NR). The 12-, 24-, and 36-month PFS rates were 94.9% (95% CI, 86.9%-98.0%), 88.7% (95% CI, 78.5%-94.2%), and 83.1% (95% CI, 69.5%-91.0%), respectively.

Furthermore, both the median disease-specific survival and median time to cystectomy were NR (95% CI, NR-NR). The rates for DFS were 98.7% (95% CI, 91.4%-99.8%) at 12 months, 96.0% (95% CI, 88.2%-98.7%) at 24 months, and 96.0% (88.2%-98.7%) at 36 months. The 12-, 24- and 36-month cystectomy-free rates were 92.2% (95% CI, 83.4%-96.4%), 87.9% (95% CI, 78.0%-93.5%), and 81.8% (95% CI, 68.1%-90.1%), respectively. Finally, the 12-, 24-, and 36-month overall survival (OS) rates were 98.7% (95% CI, 91.4%-99.8%), 94.7% (95% CI, 86.4%-98.0%), and 91.7% (95% CI, 79.9%-96.7%), respectively.

“We appreciate the FDA’s collaboration throughout this process and remain fully committed to delivering this much-needed therapy to patients who currently have no approved alternatives when standard of care fails," Richard Adcock, president and chief executive officer of ImmunityBio, said in the news release on the FDA decision.¹ "We have completed the assembly and analysis of the requested additional information and will submit it within the next 30 days for the agency’s review."

Patients with BCG-unresponsive NMIBC were enrolled on the trial and assigned them to cohorts based on papillary involvement, with cohort B (n = 80) consisting of those with grade Ta/T1 papillary NMIBC and cohort A including those with carcinoma in situ. Other eligibility criteria included those 18 years and older with an ECOG performance status of 0 to 2. Exclusion criteria included inadequate organ function; a history or evidence of muscle-invasive, locally advanced, metastatic, or extravesical bladder cancer within 5 years of study enrollment; and a life expectancy of less than 2 years.

The median age of cohort B was 72 years (range, 46-93), 74% were men, 89% were White, and 76% had a baseline ECOG performance status of 0.

The primary end point for cohort B was DFS rate at 12 months. Secondary end points included complete response rate, PFS, disease-specific survival, time to cystectomy, and safety.

A total of 61% of patients in cohorts A and B (n = 180) experienced at least 1 grade 1 or 2 treatment-related adverse effect (TRAE), with 3% experiencing at least 1 grade 3 or higher event. No grade 4/5 TRAEs, grade 3 immune-related TRAEs, or TRAEs with an outcome of death were reported in cohort B.

The most common TRAEs included dysuria (grade 1, 20%; grade 2, 6%), pollakiuria (16%; 9%), hematuria (18%; 2%), micturition urgency (12%; 4%), and fatigue (14%; 3%). Of note, 2 patients (1%) experienced grade 3 myalgia.

References

1. ImmunityBio advances regulatory discussions with FDA on potential resubmission path for ANKTIVA® in BCG-unresponsive papillary bladder cancer. News release. ImmunityBio. January 20, 2026. Accessed January 20, 2026. https://tinyurl.com/y2ujnvxc
2. Chang SS, Chamie K, Kramolowsky E, et al. Prolonged progression-free survival, disease-free survival, and cystectomy avoidance with IL-15 receptor lymphocyte–stimulating agent NAI plus Bacillus Calmette-Guérin in Bacillus Calmette-Guérin–unresponsive papillary-only nonmuscle-invasive bladder cancer. J Urol. 2026;215(1):44-56. doi:10.1097/JU.0000000000004782