Nogapendekin Alfa Inbakicept Joins NCCN Guidelines for Papillary-Only, BCG-Unresponsive NMIBC

The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology to include nogapendekin alfa inbakicept-pmln (Anktiva) in combination with BCG for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary-only disease.^1,2

The updated Version 1.2026 of the NCCN Guidelines for Bladder Cancer now includes nogapendekin alfa inbakicept plus BCG as a category 2A recommendation for the treatment of patients with BCG-unresponsive NMIBC with papillary-only disease. The update expands on the prior category 2A NCCN recommendation for the combination in BCG-unresponsive NMIBC with carcinoma in situ with or without papillary disease.

“These updated NCCN Guideline recommendations in bladder cancer represent an important milestone for patients with BCG-unresponsive NMIBC papillary-only disease who have exhausted standard BCG therapy,” Patrick Soon-Shiong, MD, founder, executive chairman, and global chief scientific and medical officer of ImmunityBio, stated in a news release.¹ “The addition of [nogapendekin alfa inbakicept] plus BCG for papillary-only disease in the NCCN Guidelines reflects the growing body of clinical data evaluating [nogapendekin alfa inbakicept] in this patient population and reinforces our commitment to developing comprehensive treatment solutions that address the full spectrum of patients living with BCG-unresponsive NMIBC. We welcome these updated guideline recommendations and await the FDA’s review of [nogapendekin alfa inbakicept] plus BCG for this indication.”

The addition of nogapendekin alfa inbakicept to the guidelines follows the March 2026 resubmission of a supplemental biologics license application (sBLA) to the FDA seeking approval for nogapendekin alfa inbakicept in patients with BCG-unresponsive NMIBC with papillary-only tumors.³ The sBLA was supported by data from cohort B of the phase 2/3 QUILT-3.032 trial (NCT03022825).

In April 2024, the FDA approved nogapendekin alfa inbakicept in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors, which was supported by data from cohort A of QUILT-3.032.⁴

What data have been shared from QUILT-3.032 for papillary-only NMIBC?

Data from cohort B of QUILT-3.032 demonstrated that patients with high-grade papillary-only NMIBC who received nogapendekin alfa inbakicept in combination with BCG (n = 80) experienced a 12-month disease-free survival (DFS) rate of 58.2% (95% CI, 46.6%-68.2%).⁵ These data met the primary end point of the trial. The respective 24- and 36-month DFS rates were 52.1% (95% CI, 40.3%-62.7%) and 38.2% (95% CI, 25.6%-50.6%).

At a median follow-up of 30.2 months (range, 3.2-62.8), the median progression-free survival (PFS), disease-specific survival (DSS), and time to cystectomy were all not reached. 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. The respective DSS rates at these time points were 98.7% (95% CI, 91.4%-99.8%), 96.0% (95% CI, 88.2%-98.7%), and 96.0% (95% CI, 88.2%-98.7%). The respective cystectomy-free rates at 12, 24, and 36 months 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%).

In terms of safety for patients treated in cohorts A and B (n = 180), grade 1 or 2 treatment-related adverse effects (TRAEs) occurred at a rate of 61%. Grade 3 TRAEs were reported in 3% of patients. No grade 4 or 5 TRAEs, TRAEs leading to death, or immune-related grade 3 TRAEs occurred.

How was QUILT-3.032 designed?

QUILT-3.032 was an open-label, multicenter study that enrolled patients at least 18 years of age with BCG-unresponsive high-grade Ta/T1 papillary NMIBC. An ECOG performance status of 2 or less was also needed. Patients with high-grade Ta and/or T1 disease were required to complete transurethral resection of the bladder tumor of their index lesions before study treatment.

All patients received nogapendekin alfa inbakicept at 400 μg in combination with BCG at 50 mg intravesically once per week for 6 consecutive weeks. The primary end point was DFS at 12 weeks. Secondary end points included PFS, DSS, cystectomy avoidance, and safety.

“This [NCCN] update is an important step in the continued evolution of clinical guidance for patients with BCG-unresponsive NMIBC and validates the growing role of immune-based therapies in the treatment landscape,” Richard Adcock, president and chief executive officer of ImmunityBio, added in the news release.¹

References

1. ImmunityBio announces NCCN Clinical Practice Guidelines in Oncology have been updated to include Anktiva plus BCG for patients with BCG-unresponsive NMIBC with papillary-only disease. News release. ImmunityBio. March 17, 2026. Accessed March 17, 2026. https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-nccnr-clinical-practice-guidelines?field_nir_news_date_value[min]=
2. NCCN. Clinical Practice Guidelines in Oncology. Bladder cancer, version 1.2026. March 16, 2026. Accessed March 17, 2026. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf
3. 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. ImmunityBio. March 17, 2026. Accessed March 9, 2026. https://immunitybio.com/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/
4. FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. FDA. April 22, 2024. Accessed March 17, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer
5. 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