On November 9, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported positive results from the final analysis of the primary endpoint in Cohort A of QUILT-2.005 (NCT02138734), a randomized, controlled, registrational trial evaluating intravesical ANKTIVA (nogapendekin alfa inbakicept-pmln/N-803) in combination with Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve, high-grade non-muscle invasive bladder cancer (NMIBC). The chemotherapy-free combination demonstrated a statistically significant improvement in efficacy compared with BCG alone in patients with carcinoma in situ (CIS), with or without papillary tumors.
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The trial involved over 75 clinical trial sites with three largest enrolling sites at US Urology Partners, Dartmouth-Hitchcock, and University of California Los Angeles. Additional study details will be presented at an upcoming medical congress.
"For nearly 40 years, BCG has been the gold standard for patients newly diagnosed with high-risk NMIBC, with limited innovation in the frontline setting," said Christopher Pieczonka, M.D., Corporate Director of Clinical Research at U.S. Urology Partners and Global Principal Investigator of the QUILT-2.005 trial. "For patients with carcinoma in situ with or without papillary tumors, the meaningful improvement in response rates when intravesical ANKTIVA is administered with BCG represents an important practice-changing advance. By improving responses earlier in the disease course, this combination has the potential to help more patients remain disease-free longer, avoid additional treatments."
"As an NCI-designated Comprehensive Cancer Center, we are committed to advancing innovative research and clinical trials that have the potential to improve outcomes for patients," said Einar F. Sverrisson, MD, Assistant Professor of Surgery at Dartmouth’s Geisel School of Medicine and urologist at Dartmouth Hitchcock Medical Center. "For patients with NMIBC, recurrence following standard-of-care BCG remains a significant challenge. This study was designed to investigate whether adding N-803 to BCG could increase the patient response rate and reduce the risk of early recurrence. We are proud to have contributed to this important research, which has the potential to reshape the treatment landscape for patients living with NMIBC."
"These results build on the clinical findings observed in patients with BCG-unresponsive NMIBC and underscore the potential of ANKTIVA plus BCG to become the first chemotherapy-free immunotherapy combination to improve treatment outcomes for patients with BCG-naïve bladder cancer," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "The statistically significant improvement in efficacy supports our efforts to extend this therapeutic approach to patients earlier in their treatment journey. We are grateful to the patients, families and clinical teams who made this study possible."
Safety of N-803 plus BCG versus BCG Alone
The most common treatment-emergent and treatment-related adverse events were consistent with those observed with BCG alone. No treatment-related deaths were reported.
About the QUILT-2.005 Study
QUILT-2.005 (NCT02138734) is a randomized, controlled registrational trial comparing the intravesical chemotherapy-free combination of ANKTIVA (nogapendekin alfa inbakicept-pmln) with BCG versus BCG alone in patients with BCG-naïve NMIBC. BCG-naïve patients are those receiving BCG-based therapy for the first time, representing an earlier stage of treatment than the BCG-unresponsive population for which ANKTIVA is currently approved. Enrollment was completed in February 2026 with 370 randomized patients. Following a protocol-specified interim review in March 2026, the IDMC determined that no additional enrollment was required to maintain the study’s prespecified statistical power. Database lock occurred on October 20, 2026 and the supplemental BLA is on track to be submitted to the FDA before year end 2026. Full details can be found on clinicaltrials.gov.
About ANKTIVA (nogapendekin alfa inbakicept-pmln)
The interleukin-15 (IL-15) cytokine 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 receptor 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. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 independent of dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.
In April 2024, ANKTIVA plus BCG was approved for BCG unresponsive NMIBC CIS with or without papillary disease. In October 2026, ANKTIVA plus BCG indication was expanded and approved for BCG unresponsive NMIBC including both CIS and papillary disease.
IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with BCG-unresponsive NMIBC have evidence of high-grade disease after a second induction course of ANKTIVA with BCG, reconsider cystectomy.
DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.
USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. For more information, please see the Prescribing Information for ANKTIVA at Anktiva.com.
(Press release, ImmunityBio, NOV 9, 2026, View Source [SID1234674473])