Study progresses of nogapendekin alfa inbakicept for BCG-naïve NMIBC

ImmunityBio has released updated enrollment progress on its ongoing pivotal QUILT-2.005 trial (NCT02138734), which is evaluating nogapendekin alfa inbakicept (Anktiva) plus BCG for patients with BCG-naïve non–muscle invasive bladder cancer (NMIBC).¹

According to the company, enrollment in the study has now reached 85%, a pace which has exceeded internal expectations. Full enrollment is expected by the second quarter of 2026, followed by the submission of a biologics license application to the FDA by the end of the year.

Nogapendekin alfa inbakicept was previously approved by the FDA in April 2024 in combination with BCG for patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors.

“We look forward to the final accrual of this important registrational randomized trial in patients with BCG-naïve non-muscle-invasive bladder cancer, which represents a substantial proportion of newly diagnosed bladder cancer cases,” said Patrick Soon-Shiong, MD, founder, executive chairman, and global chief medical and scientific officer of ImmunityBio, in the news release.¹

Interim data from the registrational trial were presented at the 2024 American Urological Association Annual Meeting in Las Vegas, Nevada.² The analysis included 43 patients who were efficacy evaluable at the time of data collection. Early findings demonstrated that the combination of nogapendekin alfa inbakicept plus BCG significantly extended the duration of complete response (CR) vs BCG alone in patients with BCG-naïve NMIBC.

CR at any time point was achieved in 85% of patients in the combination arm vs 61% in the BCG monotherapy arm (P = 0.0995). Further, 85% of patients in the combination arm maintained a CR at 6 months, compared with 57% of patients in the BCG monotherapy arm (P = .0536). At 9 months, 84% of patients in the combination arm remained in CR, compared with 52% in the BCG alone arm (P = .0455).

Soon-Shiong noted in the news release, “The interim analysis is encouraging and consistent with findings in the approved BCG-unresponsive setting, where the duration of complete response has exceeded 47 months.”

The QUILT-2.005 trial is a randomized, open-label phase 1b/2b study of nogapendekin alfa inbakicept plus BCG vs BCG alone in patients with BCG-naïve high-grade NMIBC with CIS (cohort A) and NMIBC with papillary disease only (cohort B). The study is seeking to enroll 366 patients in cohort A and 230 patients in cohort B.³

The primary end points for the trial are CR in the CIS cohort and disease-free status in the papillary cohort. Duration of response is a key secondary end point.

ImmunityBio also noted that their Expanded Access Program (NCT06810141) for recombinant BCG is continuing to progress, supporting patient access to BCG amid the ongoing shortage of TICE BCG.

REFERENCES

1. ImmunityBio advances first-line BCG naive NMIBC program with enrollment exceeding expectations and positive interim analysis for ANKTIVA® plus BCG. News release. ImmunityBio. January 16, 2026. Accessed January 19, 2026. https://immunitybio.com/immunitybio-advances-first-line-bcg-naive-nmibc-program-with-enrollment-exceeding-expectations-and-positive-interim-analysis-for-anktiva-plus-bcg/

2. ANKTIVA synergizes with T cell activity of BCG in both the naïve and unresponsive setting by activating NK cells, interferon gamma, and driving memory CD8+ killer T cells. ImmunityBio. Accessed January 19, 2026. https://immunitybio.com/wp-content/uploads/2024/05/ANKTIVA-BCG-Naive.pdf

3. Bladder cancer. ImmunityBio. Accessed January 19, 2026. https://immunitybio.com/bladder-cancer/