Anktiva Plus BCG Meets Main Goal in BCG-Naive Bladder Cancer Trial

Adding Anktiva (nogapendekin alfa inbakicept-pmln) to Bacillus Calmette-Guérin (BCG) improved responses compared with BCG alone in people with high-grade non-muscle invasive bladder cancer (NMIBC) who had not previously received BCG, according to topline results from the QUILT-2.005 trial announced by ImmunityBio, the drug's manufacturer.

The trial met its primary goal in Cohort A, which included patients with carcinoma in situ (CIS), with or without papillary tumors. CIS is a flat, high-grade form of bladder cancer that grows along the bladder lining. The company said it plans to submit an application to the Food and Drug Administration (FDA) by the end of 2026 to expand Anktiva's approval to patients earlier in their treatment.

What did the QUILT-2.005 trial show for Anktiva in BCG-naive bladder cancer?

According to the company, patients in Cohort A who received Anktiva with BCG had a statistically significant improvement in efficacy compared with those who received BCG alone. The median duration of response, or how long responses lasted, had not yet been reached at the time of the analysis, meaning more than half of patients who responded were still responding.

ImmunityBio did not release specific response rates or other numerical results. The company said additional details will be presented at an upcoming medical meeting.

Patients' reported quality of life was maintained during treatment, according to the company.

"For nearly 40 years, BCG has been the gold standard for patients newly diagnosed with high-risk NMIBC," Dr. Christopher Pieczonka, corporate director of clinical research at U.S. Urology Partners and global principal investigator of the trial, said in the news release.

How was the QUILT-2.005 trial designed?

QUILT-2.005 is a randomized, open-label registrational trial that enrolled 370 patients with BCG-naive, high-grade NMIBC at more than 75 sites. Patients were randomly assigned to receive Anktiva plus BCG or BCG alone, both placed directly into the bladder.

In March 2026, an independent data monitoring committee determined that no more patients needed to be enrolled to keep the trial's planned statistical power.

BCG, a weakened form of the bacteria that cause tuberculosis, has long been the standard first treatment after tumor removal for people with high-risk NMIBC. It works by triggering an immune response in the bladder. However, the cancer comes back in some patients after BCG treatment.

"For patients with NMIBC, recurrence following standard-of-care BCG remains a significant challenge," said Dr. Einar F. Sverrisson, an assistant professor of surgery at Dartmouth's Geisel School of Medicine and a urologist at Dartmouth Hitchcock Medical Center.

Anktiva is an immunotherapy designed to activate natural killer cells and T cells, two types of immune cells that can attack cancer. Anktiva plus BCG is already approved for adults with BCG-unresponsive NMIBC. That approval was first granted in April 2024 for disease with CIS and was expanded in October 2026 to include high-grade papillary-only tumors.

What side effects were reported with Anktiva plus BCG?

The most common side effects in patients receiving Anktiva plus BCG were similar to those seen with BCG alone, according to the company. No treatment-related deaths were reported. ImmunityBio did not release specific side effect rates.

What do the findings mean for patients with bladder cancer?

The results suggest that adding Anktiva to BCG may improve outcomes for people starting treatment for high-risk NMIBC with CIS. Anktiva plus BCG is not yet approved for patients who have not received BCG, and the full data have not yet been presented or peer reviewed.

Reference

1. “ImmunityBio Announces ANKTIVA Plus BCG Meets Primary Endpoint in BCG-Naïve Non-Muscle Invasive Bladder Cancer Randomized QUILT-2.005 Trial.” ImmunityBio. Posted: Nov. 9, 2026.

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