Supplemental BLA for Nogapendekin in Bladder Cancer Resubmitted to FDA

The FDA has acknowledged receipt of the supplemental Biologics License Application (sBLA) for nogapendekin alfa inbakicept-pmln (Anktiva) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.

The resubmission follows ongoing discussions with the FDA beginning in January 2026, during which the Agency requested additional data to support its review. The request did not include the initiation or design of any new clinical trials. ImmunityBio, the manufacturer, submitted the requested information in February 2026.

After reviewing the additional data, the FDA provided feedback in March requesting updated efficacy data. The company subsequently resubmitted the sBLA for patients with papillary-only NMIBC, including updated long-term follow-up data, and the Agency has acknowledged receipt of the filing. The long-term safety and efficacy results for nogapendekin plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors have been published in the Journal of Urology.

"The mechanism of action of Anktiva’s IL-15 superagonist activity was affirmed by the FDA's approval of Anktiva in 2024 for BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The long-term data in papillary disease alone demonstrate prolonged disease-free survival and durable bladder preservation, consistent with Anktiva's IL-15-based mechanism of action," Patrick Soon-Shiong, MD, executive chairman of the manufacturer ImmunityBio, said in a release.

ImmunityBio plans to present the clinical data supporting the SFDA approval of the chemotherapy-free regimen of nogapendekin plus checkpoint inhibitors, which demonstrated nearly double the median overall survival historically observed with docetaxel chemotherapy. The Company also intends to continue discussions with the FDA and other global regulatory authorities regarding potential treatment options for patients with second line and later metastatic NSCLC who have exhausted currently available standards of care, including checkpoint inhibitors.

QUILT 3.032 Trial

The sBLA submission for BCG-unresponsive NMIBC papillary disease is supported by long-term results from the phase 2/3 QUILT 3.032 trial (NCT03022825) in 80 patients with high-grade papillary-only NMIBC.²

Chang S, et al, reported that in patients in the BCG-nonresponsive papillary disease cohort (cohort B), the disease-free survival rates at 12, 24, and 36 months were 58.2% (95% CI, 46.6%-68.2%), 52.1% (95% CI, 40.3%-62.7%), and 38.2% (95% CI, 25.6%-50.6%), respectively. The PFS rates at 12 and 36 months were 94.9% (95% CI, 86.9%-98.0%) and 83.1% (95% CI, 69.5%-91.0%).²

Patients treated with intravesical nogapendekin plus BCG demonstrated a 96.0% disease-specific survival (DSS) rate at 36 months, with median DSS not yet reached. Progression-free survival (PFS) was 94.9% at 12 months and 83.1% at 36 months, indicating durable prevention of progression to muscle-invasive disease. Bladder preservation remained high, with cystectomy-free survival of 92.2% at 12 months and 81.8% at 36 months, meaning over 80% of patients avoided radical cystectomy through three years of follow-up. These results highlight the potential of nogapendekin plus BCG to provide durable bladder-sparing outcomes and a chemotherapy-free immunotherapy alternative for patients with high-risk papillary NMIBC.

REFERENCES

1. ImmunityBio announces resubmission of supplemental BLA to the FDA for Anktiva plus BCG in BCG-unresponsive NMIBC with papillary disease following agency review of additional data. News release. Accessed March 9, 2026. https://tinyurl.com/et4xusnp

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