ImmunityBio reports statistically significant results for ANKTIVA plus BCG in BCG-naïve bladder cancer patients in the randomized QUILT-2.005 trial.
Written By: Faiza, PharmD
Reviewed By: Pharmacally Editorial Team
ImmunityBio announced that its investigational combination of ANKTIVA® (nogapendekin alfa inbakicept-pmln; N-803) and Bacillus Calmette-Guérin (BCG) met the primary endpoint in Cohort A of the randomized QUILT-2.005 trial (NCT02138734). The study evaluated intravesical ANKTIVA plus BCG against BCG alone in patients with BCG-naïve, high-grade non-muscle invasive bladder cancer (NMIBC). The findings represent an important clinical development milestone as the company explores the use of ANKTIVA earlier in the treatment pathway.
Trial Design and Participant Characteristics
QUILT-2.005 is a randomized, controlled, registrational study comparing intravesical ANKTIVA plus BCG with BCG alone in patients receiving BCG-based treatment for the first time. The trial completed enrollment in February 2026, with 370 patients randomized across more than 75 clinical trial sites.
The three largest enrolling sites included U.S. Urology Partners, Dartmouth-Hitchcock and the University of California, Los Angeles. Following a protocol-specified interim review by the Independent Data Monitoring Committee (IDMC) in March 2026, the committee determined that additional patient enrollment was not required to preserve the study’s statistical power. Database lock occurred on October 20, 2026.
Primary Endpoint Results
The final analysis of Cohort A demonstrated a statistically significant improvement in efficacy with ANKTIVA plus BCG compared with BCG alone in patients with carcinoma in situ (CIS), with or without papillary tumors.
However, ImmunityBio has not disclosed the numerical efficacy results, treatment-group response rates or detailed statistical estimates in its announcement. These data will be important for assessing the magnitude and clinical relevance of the observed treatment benefit. Further study details are expected to be presented at an upcoming medical congress.
The reported achievement of statistical significance establishes that the trial met its primary endpoint, but the extent of benefit cannot yet be independently assessed from the publicly disclosed information.
Secondary Endpoint Findings
ImmunityBio also reported that patient-reported quality of life was maintained throughout the treatment period. Additionally, the median duration of response had not been reached at the time of the final analysis.
An unreached median duration of response indicates that the available follow-up has not yet established the time point at which half of the responding patients experienced a loss of response. Longer follow-up and detailed response data will be necessary to characterize the durability of treatment benefit.
Safety Findings
The most common treatment-emergent and treatment-related adverse events observed with ANKTIVA plus BCG were consistent with those typically reported with BCG alone. No treatment-related deaths were reported during the study.
Although these findings provide an initial overview of tolerability, detailed comparative safety data, including adverse-event frequencies and severity, have not yet been disclosed.
Regulatory Status
ANKTIVA received its initial FDA approval in April 2024, in combination with BCG, for adults with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. In October 2026, the FDA expanded its indication to include adults with BCG-unresponsive NMIBC with high-grade papillary-only tumors.
Following the QUILT-2.005 findings, ImmunityBio plans to submit a supplemental Biologics License Application (sBLA) to the FDA before the end of 2026, seeking an expansion into the BCG-naïve setting. This proposed indication remains subject to FDA review and has not yet received regulatory approval.
Clinical Significance and Outstanding Questions
ANKTIVA is an IL-15 receptor agonist designed to stimulate natural killer (NK) cells and CD8-positive T cells. Its combination with BCG provides a rationale for investigating immune-based treatment approaches in NMIBC.
The QUILT-2.005 findings are particularly relevant because they extend the clinical investigation beyond BCG-unresponsive disease into a population receiving BCG-based treatment for the first time. If supported by the detailed efficacy and safety dataset and subsequent regulatory review, this approach could expand treatment options for patients with high-grade NMIBC.
However, several questions remain unresolved. The absence of numerical efficacy estimates limits assessment of the magnitude of benefit over BCG alone. Further information on response durability, comparative safety and longer-term outcomes will be important in evaluating the clinical value of the combination.
The upcoming presentation of detailed trial findings and the planned FDA submission will therefore be important next steps in determining whether ANKTIVA plus BCG can establish a role in earlier-stage NMIBC treatment.
References
ImmunityBio Announces ANKTIVA® Plus BCG Meets Primary Endpoint in BCG-Naïve Non-Muscle Invasive Bladder Cancer Randomized QUILT-2.005 Trial, ImmunityBio, Inc., November 9, 2026.
A Study of Intravesical BCG in Combination With ALT-803 in Patients with Non-Muscle Invasive Bladder Cancer, ClinicalTrials.gov ID NCT02138734
About the Writer
Faiza (Linkedin) is a Healthcare Writer at Pharmacally and a PharmD professional from St. Peter’s Institute of Pharmaceutical Sciences, Kakatiya University. she has academic and clinical interests in clinical pharmacy, pharmacovigilance and patient care. Her research focuses on serum biomarkers in acute pancreatitis and medication adherence. She is interested in clinical research, medical writing and evidence-based healthcare communication.