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

Database lock is complete for cohort A of the QUILT-2.005 trial (NCT02138734), comparing nogapendekin alfa inbakicept-pmln (NAI; Anktiva) plus BCG with BCG alone in patients with BCG-naïve non–muscle invasive bladder cancer (NMIBC), ImmunityBio announced.¹ This allows the investigators to proceed to the study’s final efficacy analysis.

Cohort A includes 366 patients and is evaluating whether adding the interleukin-15 (IL-15) receptor agonist to BCG improves complete response (CR) rates compared with BCG alone. ImmunityBio noted that topline results were expected in November 2026 and that a supplemental biologics license application (sBLA) submission to the FDA remained planned for the fourth quarter of 2026.

"With the database lock now complete in this randomized trial of 366 patients, we are entering a critical phase of validating the important role an IL-15 superagonist plays in the next evolution of immunotherapy," said Patrick Soon-Shiong, MD, founder, executive chairman, and global chief medical and scientific officer of ImmunityBio, in the company's announcement.¹ “The final analysis of this study will determine whether adding Anktiva to BCG improves complete response rates and the durability of those responses when compared with BCG alone, potentially resulting in the first intravesical, chemotherapy-free treatment approach for patients with BCG-naïve NMIBC. We look forward to sharing the findings once the analysis is complete.”

Nogapendekin alfa inbakicept is currently approved in the US in combination with BCG for patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors and for patients with BCG-unresponsive NMIBC with high-grade papillary-only tumors.

QUILT-2.005 trial design and end points

QUILT-2.005 is an open-label, multicenter, randomized study evaluating intravesical nogapendekin alfa inbakicept plus BCG against BCG monotherapy in patients with BCG-naïve, high-grade NMIBC.² The study includes 2 cohorts: Cohort A, comprising patients with CIS with or without papillary disease, and Cohort B, comprising patients with high-grade papillary-only disease (Ta/T1). Participants were eligible for enrollment if they were eligible to receive BCG, had an ECOG performance score of 0 to 2, and had adequate laboratory test results and pulmonary function.

The 366 patients in Cohort A were randomly assigned 1:1 to receive nogapendekin alfa inbakicept plus BCG or BCG alone. Both treatment groups receive weekly intravesical instillations during a 6-week induction period, followed by response assessments and maintenance treatment for eligible patients. The primary efficacy end point for Cohort A is CR rate at 6 months. Disease-free survival is being evaluated in Cohort B.

In March 2026, the company reported that an independent data monitoring committee (IDMC) reviewed interim data from 183 evaluable patients in Cohort A and determined that the study had sufficient statistical power to detect the prespecified clinically meaningful difference between treatment groups.³ Consequently, the committee recommended that enrollment could conclude without additional patients.

ImmunityBio also previously reported that an interim analysis demonstrated statistically significant longer duration of CR with nogapendekin alfa inbakicept plus BCG compared with BCG alone. At 6 months, 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 = 40), these rates were 84% vs 52%, respectively, with the difference reaching statistical significance (P = .0455).^4,5 No new serious adverse events were reported.

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REFERENCES

1. ImmunityBio announces database lock for registrational trial of locally delivered, chemotherapy-free ANKTIVA® plus BCG in BCG-naïve non-muscle invasive bladder cancer. News release. ImmunityBio. October 21, 2026. Accessed October 30, 2026. https://immunitybio.com/immunitybio-announces-database-lock-for-registrational-trial-of-locally-delivered-chemotherapy-free-anktiva-plus-bcg-in-bcg-naive-non-muscle-invasive-bladder-cancer/

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 October 30, 2026. https://clinicaltrials.gov/study/NCT02138734

3. ImmunityBio confirms statistical power in pivotal randomized BCG-naïve NMIBC trial to detect clinically meaningful differences between ANKTIVA® plus BCG versus BCG alone; Supplemental BLA submission on track for 2026. News release. ImmunityBio. March 26, 2026. Accessed October 30, 2026. https://www.businesswire.com/news/home/20260326666809/en/ImmunityBio-Confirms-Statistical-Power-in-Pivotal-Randomized-BCG-Nave-NMIBC-Trial-to-Detect-Clinically-Meaningful-Differences-Between-ANKTIVA-Plus-BCG-Versus-BCG-Alone-Supplemental-BLA-Submission-on-Track-for-2026

4. 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 October 30, 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

5. 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 October 30, 2026. https://immunitybio.com/wp-content/uploads/2024/05/ANKTIVA-BCG-Naive.pdf