FDA approves nogapendekin alfa inbakicept plus BCG for papillary-only BCG-unresponsive NMIBC

The FDA has approved nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG for patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with high-grade papillary-only tumors.¹

This expands the prior indication for this agent, which was for patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors.

Data on nogapendekin alfa inbakicept

Nogapendekin alfa inbakicept was previously approved based on data from Cohort A of the QUILT-3.032 (NCT03022825). The single-arm, multicenter study included 77 patients with BCG-unresponsive, high-risk NMIBC with CIS with or without Ta/T1 papillary disease following transurethral resection.

The complete response (CR) rate was 62% (95% CI, 51 to 73). Among complete responders, 58% achieved a duration of response (DOR) 12 months or longer, and 40% achieved a DOR 24 months or longer.

These results supported the initial indication for patients with CIS, including those with concomitant papillary tumors. The FDA determined that, given overlapping clinical and non-clinical features of CIS and papillary disease, these efficacy results could be extrapolated to support the expanded indication for patients with BCG-unresponsive high-grade papillary disease.

Importantly, published follow-up data from the papillary-only cohort of QUILT-3.032 provide additional clinical context.² In this cohort, patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC received intravesical nogapendekin alfa inbakicept plus BCG. At the July 15, 2024, data cutoff, disease-free survival rates were 58.2% at 12 months, 52.1% at 24 months, and 38.2% at 36 months. Progression-free survival rates were 94.9% at 12 months and 83.1% at 36 months. Cystectomy avoidance rates were 92.2% and 81.8% at 12 and 36 months, respectively.

Regarding safety, the most common adverse events (≥15%) with the combination, including laboratory test abnormalities, were increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia, according to the FDA.

Recommended dose

The recommended dose for nogapendekin alfa inbakicept, per the FDA, is 400 mcg administered intravesically with BCG once a week for 6 weeks as induction therapy. If residual CIS and/or high-grade Ta tumors are present at month 3, clinicians may offer a second induction course.

Maintenance treatment consists of 3 weekly instillations at months 4, 7, 10, 13, and 19, for a total of 15 maintenance doses. For patients without evidence of high-grade disease at month 25 and thereafter, additional maintenance courses may be administered at months 25, 31, and 37, for up to 9 additional instillations. The maximum treatment duration is 37 months.

Treatment should be discontinued for persistent disease after the second induction course, disease recurrence or progression, or unacceptable toxicity.

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REFERENCES

1. FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. News release. US Food & Drug Administration. October 14, 2026. Accessed October 14, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle?utm_medium=email&utm_source=govdelivery

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