Pivotal trial of NAI plus BCG for BCG-naïve NMIBC reaches enrollment goal

The target enrollment has been met in the pivotal phase 2 QUILT 2.005 trial (NCT02138734), evaluating the combination of nogapendekin alfa inbakicept-pmln (NAI, Anktiva) plus BCG for patients with BCG-naïve non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors, ImmunityBio announced.¹

An interim analysis of the data, which was requested by the FDA, showed that the combination led to a statistically significant improvement in duration of complete response vs BCG alone, with no significant safety concerns. These data were submitted to the agency and presented at the 2024 American Urological Association Annual Meeting.

“The interim results from this randomized study are encouraging and suggest that Anktiva plus BCG may improve the durability of response in patients with BCG-naïve NMIBC,” said global principal investigator Christopher M. Pieczonka, MD, Corporate Director of Clinical Research at US Urology Partners, in the news release.¹ “Given the historical limitations of BCG alone, continued evaluation of this combination has the potential to inform future treatment strategies and potentially change the current standard-of-care recommendations for NMIBC. Importantly, no new or worsening safety signals have been observed to date, which is encouraging when considered alongside prior studies evaluating BCG in combination with checkpoint inhibitors in this disease setting.”

The open-label, multi-center QUILT 2.005 trial is enrolling patients across 2 cohorts: patients with BCG-naïve high-grade NMIBC with CIS (cohort A), and those with papillary only disease (cohort B). Cohort A has completed enrollment ahead of schedule with 366 patients. Cohort B is expected to enroll 230 patients.²

Patients in the trial are randomly assigned to receive nogapendekin alfa inbakicept plus BCG or BCG alone. The primary end point in cohort A was complete response rate.

At the 6-month interim analysis, 85% of patients in the combination arm maintained a complete response compared with 57% of patients in the BCG monotherapy arm (P = .0536). At 9 months (n = 43), these rates were 84% vs 52%, respectively, with the difference reaching statistical significance (P = .0455).³

According to ImmunityBio, no significant safety concerns have been reported with the combination.

The company expects additional data from the trial to be available in Q4 of 2026. They also plan to submit a biologics license application to the FDA by Q4 of 2026.

“We are encouraged by these interim results and await the final unblinding of the completed trial,” concluded Patrick Soon-Shiong, MD, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, in the news release.¹ “If approved, Anktiva plus BCG could offer a new treatment option earlier in the disease course for patients with NMIBC CIS, building on the therapy’s existing approval in the BCG-unresponsive setting.”

In parallel to the QUILT 2.005 trial, the company is also enrolling patients in an Expanded Access Program (EAP) (NCT06810141) for recombinant BCG. The EAP is intended to support patient access to BCG during the ongoing TICE BCG shortage. In total, the program has enrolled 580 patients throughout the US.

ImmunityBio also shared that they have “requested consultation with the FDA regarding the potential approval of recombinant BCG as an alternative supply source in anticipation of continued clinical need, including for patients with BCG-naïve disease.”

REFERENCES

1. ImmunityBio completes enrollment in pivotal randomized trial evaluating ANKTIVA® plus BCG versus BCG alone in BCG-naïve non-muscle invasive bladder cancer carcinoma in situ. News release. ImmunityBio. February 26, 2026. Accessed March 3, 2026. https://www.businesswire.com/news/home/20260226601563/en/ImmunityBio-Completes-Enrollment-in-Pivotal-Randomized-Trial-Evaluating-ANKTIVA-Plus-BCG-Versus-BCG-Alone-in-BCG-Nave-Non-Muscle-Invasive-Bladder-Cancer-Carcinoma-In-Situ

2. Bladder cancer. ImmunityBio. Accessed March 3, 2026. https://immunitybio.com/bladder-cancer/

3. 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. May 2024. Accessed March 3, 2026. https://immunitybio.com/wp-content/uploads/2024/05/ANKTIVA-BCG-Naive.pdf