ImmunityBio Completes Enrollment in ANKTIVA Plus BCG Trial for Bladder Cancer

ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company, announced completion of enrollment in its Phase 2 clinical trial evaluating ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors. The QUILT 2.005 trial (NCT02138734), which completed enrollment ahead of schedule, includes 366 patients randomized to receive either BCG alone, the current standard-of-care for NMIBC CIS, or ANKTIVA in combination with BCG.

An interim analysis requested by the U.S. Food and Drug Administration (FDA) demonstrated that treatment with ANKTIVA plus BCG resulted in a statistically significant improvement in the duration of complete response compared with BCG alone, with no significant safety concerns reported. The interim analysis demonstrated that at six months, 85% of patients receiving ANKTIVA plus BCG maintained a complete response, compared with 57% of patients treated with BCG alone. At nine months, 84% of subjects in the ANKTIVA plus BCG arm maintained a complete response, compared with 52% of patients in the BCG-alone arm. Despite the limited sample size of the interim analysis, the difference in duration of complete response at nine months reached statistical significance (p=0.0455).

The Corporate Director of Clinical Research at U.S. Urology Partners and Global Principal Investigator of the trial stated that 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. The investigator noted that 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.

Additional study results are expected to be available in the fourth quarter of 2026. Based on these data, ImmunityBio anticipates submitting a biologics license application (BLA) to the FDA by Q4 2026. The Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio stated that 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, ImmunityBio continues to address the ongoing shortage of TICE® BCG through its Expanded Access Program (EAP) for recombinant BCG (NCT06810141), which is progressing and supporting patient access. The Company has 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. The EAP is ongoing, with 580 patients currently enrolled throughout the U.S.

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells.