ImmunityBio Announces Key Milestone With ANKTIVA in BCG-Unresponsive NMIBC CIS Trial

ImmunityBio, Inc. has announced promising updates from its QUILT 3.032 trial, marking the enrollment of its 100^th patient with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS). The trial evaluates the combination of ANKTIVA (nogapendekin alfa inbakicept-pmln) and BCG, showing a 71% complete response (CR) rate among participants, with some responses lasting up to 54 months.

The QUILT 3.032 study is a single-arm, multicenter trial designed to assess the safety and efficacy of ANKTIVA plus BCG in patients with limited treatment options due to BCG-unresponsive disease. The study’s CR rate of 71% for 100 patients aligns with earlier results published in The New England Journal of Medicine.

Among responders, the duration of response represents a significant advancement in this field. The study’s findings underline ANKTIVA’s potential to redefine treatment paradigms for NMIBC CIS, a disease with historically limited therapeutic options.

ANKTIVA leverages the cytokine interleukin-15 (IL-15), a critical immune system component that supports the activation and proliferation of natural killer (NK) cells and CD8+ T cells. As a first-in-class IL-15 agonist IgG1 fusion complex, ANKTIVA mimics the natural properties of membrane-bound IL-15 receptors, enhancing immune memory and enabling prolonged tumor control.

By driving the proliferation of NK cells, CD4+, and CD8+ T cells, ANKTIVA induces immunogenic cell death, resulting in durable responses and improved tumor suppression.

According to Patrick Soon-Shiong, MD, executive chairman and global chief scientific and medical officer for ImmunityBio, “These results highlight the potential of ANKTIVA to transform the treatment landscape for patients with BCG-unresponsive NMIBC CIS, offering hope for improved outcomes and cystectomy avoidance, especially with the prolonged duration of response now ranging as much as 54 months in this 100-patient analysis. Duration of complete response is the key efficacy element in driving cystectomy avoidance in this BCG-unresponsive population.”

ImmunityBio plans to submit the updated data to the European Medicines Agency as part of a Marketing Authorization Application in the fourth quarter of 2024. If approved, ANKTIVA could become a leading option for patients with NMIBC CIS in the European Union.