Nogapendekin alfa inbakicept plus BCG meets primary end point in BCG-naïve NMIBC

The addition of nogapendekin alfa inbakicept-pmln (N-803; Anktiva) to BCG significantly improved efficacy compared with BCG alone in patients with BCG-naïve, high-grade non-muscle invasive bladder cancer (NMIBC), according to topline results from cohort A of the QUILT-2.005 trial (NCT02138734).¹

The findings suggest a potential role for the combination earlier in the NMIBC treatment course. The FDA initially approved nogapendekin alfa inbakicept in April 2024 in combination with BCG for adults with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors. In October 2026, the FDA expanded the indication to include adults with BCG-unresponsive NMIBC and high-grade papillary-only tumors.

“For nearly 40 years, BCG has been the gold standard for patients newly diagnosed with high-risk NMIBC, with limited innovation in the frontline setting,” said Christopher Pieczonka, MD, Corporate Director of Clinical Research at US Urology Partners and global principal investigator of the QUILT-2.005 trial, in the news release from ImmunityBio.¹ “For patients with carcinoma in situ with or without papillary tumors, the meaningful improvement in response rates when intravesical Anktiva is administered with BCG represents an important practice-changing advance. By improving responses earlier in the disease course, this combination has the potential to help more patients remain disease-free longer [and] avoid additional treatments.”

QUILT-2.005 trial design and findings

QUILT-2.005 is an open-label, multicenter, randomized controlled registrational study comparing intravesical nogapendekin alfa inbakicept plus BCG with BCG monotherapy in patients with BCG-naïve, high-grade NMIBC.² The study includes 2 cohorts. Cohort A enrolled patients with CIS, with or without papillary tumors and Cohort B included patients with high-grade papillary-only disease (Ta/T1).

In Cohort A, 370 patients were randomized to receive either the combination or BCG alone. Both groups received weekly intravesical instillations during a 6-week induction period, followed by response assessments and maintenance treatment for eligible patients. The primary efficacy end point was complete response (CR) rate at 6 months. Disease-free survival is being evaluated in Cohort B.

Enrollment in the study was completed in February 2026. Following a protocol-specified interim review in March 2026, an independent data monitoring committee determined that the study had sufficient statistical power to detect the prespecified difference between treatment groups without additional enrollment. The database was locked on October 20, 2026, according to ImmunityBio.

Related: Nogapendekin alfa inbakicept plus BCG advances to final analysis in BCG-naïve NMIBC

The company reported that median duration of response had not been reached in the combination arm. The safety profile was described as generally consistent with that of BCG alone, with the most common treatment-emergent and treatment-related adverse events reportedly occurring at similar patterns in both groups. No treatment-related deaths were reported. Patient-reported quality of life was also maintained, according to the announcement.

Full results from QUILT-2.005, including the prespecified efficacy analyses and detailed safety findings, are expected to be presented at an upcoming medical congress. ImmunityBio also plans to submit a supplemental biologics license application for nogapendekin alfa inbakicept plus BCG in this patient population by year-end 2026.

“For patients with NMIBC, recurrence following standard-of-care BCG remains a significant challenge,” said Einar F. Sverrisson, MD, assistant professor of surgery at Dartmouth’s Geisel School of Medicine and urologist at Dartmouth Hitchcock Medical Center, in the news release.¹ “This study was designed to investigate whether adding N-803 to BCG could increase the patient response rate and reduce the risk of early recurrence. We are proud to have contributed to this important research, which has the potential to reshape the treatment landscape for patients living with NMIBC.”

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REFERENCES

1. ImmunityBio announces ANKTIVA® plus BCG meets primary endpoint in BCG-naïve non-muscle invasive bladder cancer randomized QUILT-2.005 trial. News release. ImmunityBio. November 9, 2026. Accessed November 9, 2026. https://immunitybio.com/immunitybio-announces-anktiva-plus-bcg-meets-primary-endpoint-in-bcg-naive-non-muscle-invasive-bladder-cancer-randomized-quilt-2-005-trial/

2. A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer. ClinicalTrials.gov. Last updated March 31, 2026. Accessed November 9, 2026. https://clinicaltrials.gov/study/NCT02138734