Announcement • May 21

ImmunityBio Announces FDA Acceptance Of Supplemental BLA For ANKTIVA Plus BCG In BCG-Unresponsive Non-Muscle Invasive Bladder Cancer With Papillary Disease

ImmunityBio, Inc. announced that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) for ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 6, 2027. In the filing communication, the FDA stated, “In support of this expansion, one has submitted the results of QUILT-3.032 Cohort B and a literature-based rationale proposing that papillary NMIBC has an overlapping clinical and non-clinical profile with CIS that may allow for extrapolation of results from patients with CIS, as was demonstrated in QUILT-3.032 Cohort A, the basis of the existing indication, to those with papillary-only disease.” The Agency further provided insight as to the focus of the review of this sBLA by stating, “The scientific data detailing these overlapping features will be the focus of the review of this sBLA to determine if there is adequate justification to allow for such an extrapolation and expansion of the indication of Anktiva with BCG to include the treatment of patients with BCG-unresponsive NMIBC with papillary tumors,” while reiterating their concerns relating to single-arm trials in papillary disease alone (Cohort B) in which the initial indication for CIS and papillary disease (Cohort A) has already been approved in a single-arm trial. If approved, the sBLA would expand the current indication for ANKTIVA plus BCG and further broaden treatment options for patients with BCG-unresponsive NMIBC. The supplemental application is supported by data from the QUILT 3.032 Phase 2/3 trial (Cohort B; NCT03022825) in 80 patients with high-grade papillary-only NMIBC. As published in The Journal of Urology(Chang et al., 2025), the study met its primary endpoint with a 12-month disease-free survival (DFS) rate of 58.2% (95% confidence interval: 46.6-68.2%). The secondary endpoints of the chemo-free immunotherapy based treatment of ANKTIVA plus BCG in Cohort B that identifies the results addressing this goal of delaying progression into muscle-invasiveness and accomplishing bladder sparing are: Progression Free Survival (PFS), Cystectomy Free Survival, Disease Specific Survival (DSS). The data submitted to the Agency regarding these secondary endpoints for consideration and published in peer reviewed journals (New England Journal of Medicine and Journal of Urology), as well as accepted by NCCN with a Category 2A designation for patients treated with intravesical ANKTIVA plus BCG with BCG unresponsive non-muscle invasive bladder cancer and papillary disease alone demonstrated: Progression-Free Survival (PFS): 94.9% at 12 months and 82.0% at 36 months, indicating durable prevention of progression to muscle-invasive disease. Cystectomy Free Survival: Bladder preservation remained high, with cystectomy-free survival of 92.2% at 12 months and 83.1% at 36 months, meaning over 80% of patients avoided radical cystectomy through three years of follow-up. Disease-Specific Survival (DSS): 96.0% Disease-Specific Survival (DSS) rate at 36 months, with median DSS not yet reached at time of submission of the sBLA. The safety data submitted in this supplemental BLA was consistent with the safety data of the indication already approved, demonstrating qualitatively that the serious adverse events of ANKTIVA when combined with BCG was consistent with that of BCG alone. ANKTIVA plus BCG was previously approved by the FDA in April 2024 for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. Non-muscle-invasive bladder cancer (NMIBC) represents approximately 80% of all bladder cancer diagnoses in the United States, approximately 85% of people diagnosed with NMIBC in the U.S. each year present with papillary disease. Patients with papillary disease who become unresponsive to BCG therapy face a high risk of recurrence and progression and often have limited bladder-sparing treatment options available. 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 by 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. ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

ImmunityBio, Inc. Stock Price

IBRX Share Price Performance

IBRX Community Narratives

Global Immunotherapy Expansion And AI Automation Will Reshape Long Term Prospects

Expanded Immunotherapy Platform And Automation Will Transform Long Term Earnings Power

Single Asset Dependence And Regulatory Hurdles Will Gradually Give Way To Broader Platform Potential

Expanded Immunotherapy Platform And Automation Will Transform Long Term Earnings Power

Single Asset Dependence And Regulatory Hurdles Will Gradually Give Way To Broader Platform Potential

Global Immunotherapy Expansion And AI Automation Will Reshape Long Term Prospects

Trending Discussion

Recently Updated Narratives

Expanded Immunotherapy Platform And Automation Will Transform Long Term Earnings Power

Single Asset Dependence And Regulatory Hurdles Will Gradually Give Way To Broader Platform Potential

Global Immunotherapy Expansion And AI Automation Will Reshape Long Term Prospects

Snowflake Analysis

ImmunityBio, Inc. Key Details

About IBRX

Recent IBRX News & Updates

ImmunityBio Sees FDA Review Milestone and Analyst Support for Bladder Cancer Therapy

Price target decreased by 17% to US$13.00

ImmunityBio Announces FDA Acceptance Of Supplemental BLA For ANKTIVA Plus BCG In BCG-Unresponsive Non-Muscle Invasive Bladder Cancer With Papillary Disease

Recent updates

ImmunityBio, Inc. Competitors

Alnylam Pharmaceuticals

Agilent Technologies

Teva Pharmaceutical Industries

Waters