2. UroToday Home

Transformative Evidence

ANKTIVA

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
Videos

N-803 Discussion Videos

Physician-Scientist Review Articles
State of the Evidence Review Articles
Written by Zachary Klaassen, MD, MSc, Wellstar MCG Health, Georgia Cancer Center, Augusta, Georgia, USA
November 18, 2024
Intravesical Bacillus Calmette-Guerin (BCG) currently remains the standard of care, guideline recommended treatment of choice in the adjuvant setting for intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC) due to its ability to reduce the risk of disease recurrence and disease progression.
Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Sandeep Reddy, MD
The 2024 American Urological Association (AUA) annual meeting featured a session on bladder cancer trials in progress, and a presentation by Dr. Sandeep Reddy discussing QUILT 2.005, a trial comparing intravesical BCG in combination with the IL-15 superagonist N-803 to BCG alone in patients with BCG-naïve non muscle invasive bladder cancer.
Presented by Patrick Soon-Shiong, MD
(UroToday.com) The 2024 American Urological Association (AUA) Annual Meeting held in San Antonio, TX between May 3rd and 6th, 2024 was host to a non-invasive bladder cancer moderated poster session. Dr. Patrick Soon-Shiong presented updated results of the QUILT 3.032 trial of N-803 plus BCG in patients with BCG-unresponsive high-grade NMIBC (NCT03022825).
Presented by Karim Chamie, MD
The 2023 GU ASCO annual meeting included a session on urothelial carcinoma, featuring a presentation by Dr. Karim Chamie discussing quality of life in the QUILT 3.032 study, specifically patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving IL-15RαFc superagonist N-803 plus BCG.
Presented by Karim Chamie, MD
It has been hypothesized that the IL-15 superagonist N-803 could boost the immune response to BCG, thus augmenting patient responses to BCG therapy and limit the need for cystectomy in this disease context. Dr. Chamie presented results from the QUILT 3032 phase 2/3 study using the IL-15 superagonist N-803 in combination with BCG in previously BCG-unresponsive bladder cancer.
Presented by Karim Chamie, MD
The 2022 ASCO annual meeting featured an oral abstract session on kidney and bladder cancer, including a presentation by Dr. Karim Chamie discussing the final results of the trial assessing IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive CIS and papillary NMIBC.
Publications
Peer-Reviewed Journal Abstracts

This is a summary of two studies that looked at the safety and effectiveness of a potential new treatment, N-803 (Anktiva), in combination with a standard treatment bacillus Calmette-Guerin (BCG) for people with non-muscle invasive bladder cancer (NMIBC).

One study was a Phase 1b study that tested increasing doses of N-803 in combination with the same dose of BCG in people with NMIBC who had never received BCG previously (BCG-naive).

In the phase 2/3 study QUILT 3.032 (NCT03022825), the ability of the IL-15RαFc superagonist N-803 (nogapendekin alfa inbakicept or NAI) plus bacillus Calmette-Guerin (BCG) to elicit durable complete responses (CRs) in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) was demonstrated.

As a secondary endpoint, patient-reported outcomes (PROs) were assessed.

Intravesical BCG is active against non-muscle invasive bladder cancer (NMIBC), but bladder cancer will recur and even progress in a significant number of patients. To improve the response rate, N-803, an IL-15 superagonist was administered in combination with BCG.

Intravesical Bacille Calmette-Guérin (BCG) remains the most effective treatment for high-risk non-muscle-invasive bladder cancer (NMIBC), unfortunately there is no validated biomarker to predict clinical outcome.

Press Releases
Official Announcements on Clinical Developments
  • ANKTIVA® reaches U.S. commercial and Medicare insurance coverage milestone within three months of FDA approval
  • Global expansion of commercial and clinical bladder cancer programs
    • Filing process initiated with European Medicines Agency (EMA) for regulatory approval of ANKTIVA in European Union countries
    • Global filing for BCG naïve trial initiated (QUILT-2.005) in India
  • ANKTIVA Non-Small Cell Lung Cancer (NSCLC) FDA meeting held in June 2024
  • Collaboration will result in BCG manufacture at large scale for use in combination with ANKTIVA®, ImmunityBio’s recently approved treatment for non-muscle invasive bladder cancer (NMIBC)
  • Serum Institute of India (SII) will manufacture both standard BCG (“sBCG”) and next-generation recombinant BCG (“iBCG”), creating a long-term solution to chronic BCG supply shortage issues
  • This acceptance represents the first regulatory filing for N-803, an IL-15 superagonist, which was granted Breakthrough Therapy and Fast Track designations in combination with Bacillus Calmette-Guérin (BCG) from the U.S. Food and Drug Administration (FDA) for this indication with a target PDUFA date of May 23, 2023
  • QUILT 3.032 study completes planned enrollment of BCG unresponsive non-muscle invasive bladder cancer CIS cohort with a 59% probability of patients maintaining complete response for at least 12 months
  • Over 85% of patients in this study have avoided a cystectomy to date
  • Breakthrough status for ImmunityBio’s superagonist Anktiva N-803 in this indication
  • Biologics License Application filing anticipated in the second half of 2021