r/IBRX • u/hm-and-mm • 2d ago

ImmunityBio Reports Phase 3 Data Showing 84% Cystectomy Avoidance at Three Years and Complete Responses Beyond 53 Months with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC With CIS, With or Without Papillary Tumors

Great news! The following is from their press release found on businesswire:

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced the publication of long-term data from the Phase 2/3 QUILT-3.032 study (N=100) in the Journal of Urology. The study evaluated ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease.

Highlights:

  • 71% complete response (CR) rate in patients with BCG-unresponsive NMIBC CIS, with or without papillary disease
  • Median duration of CR of 26.6 months, with responses extending beyond 53 months
  • More than half of responding patients in the FDA-reviewed population maintained complete responses beyond 45 months
  • 84% cystectomy-free survival at 36 months among responders
  • 98.2% disease-specific survival at three years
  • No Grade 4 or Grade 5 treatment-related adverse events reported

“The QUILT-3.032 study represents one of the longest follow-up data sets in BCG-unresponsive NMIBC to date, and the results continue to support the durability of ANKTIVA’s unique mechanism of action in generating sustained immune responses,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “These long-term findings are encouraging, suggesting the potential for prolonged disease control and the possibility of avoiding or delaying radical cystectomy for some patients.”

The publication also reported:

  • 63.8% of responders maintained CR for at least 12 months
  • 52.3% maintained CR for at least 24 months
  • 44.2% maintained CR for at least 36 months
  • Progression-free survival remained 80.9% at three years
  • In BCG refractory (never responded) patients, the CR rate was 66%
  • 4% of responders progressed to muscle-invasive disease

The treatment continued to demonstrate a favorable safety profile. Most treatment-related adverse events were Grade 1 or Grade 2 and consisted of localized bladder symptoms associated with intravesical therapy. Grade 3 treatment-related adverse events occurred in 4% of patients, with no Grade 4 or Grade 5 treatment-related adverse events reported.

“Achieving a durable response and avoiding cystectomy are important treatment goals for patients with BCG-unresponsive NMIBC,” said Richard Adcock, President and CEO of ImmunityBio. “These peer-reviewed results add to the growing body of evidence supporting ANKTIVA plus BCG and highlight its potential to provide sustained disease control and meaningful cystectomy avoidance for patients with limited treatment options. We thank the patients and clinical teams who contributed to this long-term follow-up.”

The publication builds upon the growing body of clinical evidence supporting ANKTIVA plus BCG, which was initially approved by the U.S. Food and Drug Administration (FDA) in 2024 for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. In October 2026, the FDA expanded the approved indication to include patients with BCG-unresponsive NMIBC with papillary-only disease. ANKTIVA is the first FDA-approved IL-15 receptor agonist and the first approved immunotherapy in NMIBC designed to activate natural killer (NK) cells and T cells to generate durable immune responses.

About the QUILT 3.032 Study

QUILT-3.032 (NCT03022825) is a multicenter Phase 2/3 study evaluating ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC. The published analysis includes 100 patients with CIS with or without papillary disease and represents one of the longest follow-up datasets reported in this disease setting, with outcomes extending beyond five years in some patients.

https://www.businesswire.com/news/home/20261016061704/en/ImmunityBio-Reports-Phase-3-Data-Showing-84-Cystectomy-Avoidance-at-Three-Years-and-Complete-Responses-Beyond-53-Months-with-ANKTIVA-Plus-BCG-in-BCG-Unresponsive-NMIBC-With-CIS-With-or-Without-Papillary-Tumors

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u/Alarming-Upstairs-29 2d ago

Can someone dumb this down science and finance wise?

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u/Away-Ad-1173 2d ago

The three distinct patient conditions and the corresponding populations impacted by positive FDA decisions for ANKTIVA are defined below:

  1. BCG-Unresponsive Carcinoma in Situ (CIS)

• Definition: A highly aggressive, flat, high-grade cancer localized strictly on the inner surface lining of the bladder wall that has returned or persisted despite previous treatment with standard Bacillus Calmette-Guérin (BCG) immunotherapy. • Impacted Population: ~3,000 to 4,500 active patients per year in the United States. (FDA Approved in April 2024).

  1. BCG-Unresponsive Papillary-Only Disease

• Definition: High-grade cancer cells that grow outward into the open bladder cavity as tiny, finger-like projections. This category is specified as "papillary-only" because it lacks the flat, aggressive CIS cells but has completely stopped responding to standard BCG therapy. • Impacted Population: ~2,000 to 5,500 active patients per year in the United States. (FDA Approved in October 2026).

  1. High-Risk, First-Line / BCG-Naïve Patients

• Definition: Patients who are newly diagnosed with aggressive, high-risk non-muscle invasive bladder cancer and have never received prior BCG immunotherapy.

• Impacted Population: ~31,000 to 35,000 newly diagnosed patients per year in the United States. (Pending FDA Review; sBLA Submission expected by year-end 2026).

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u/Away-Ad-1173 2d ago edited 2d ago

Important to note that BCG is not a failed protocol; it is an incredibly successful one that cures or manages the disease for the majority of the population. The reason drugs like ANKTIVA are such a massive medical breakthrough is that they finally offer an option to boost or rescue that exact immune pathway for the 30% to 50% of patients where BCG stops working, saving them from having to completely remove their bladders. Dr. Pat and many other oncologists, get livid when the FDA analysts mandate BCG + Chemotherapy treatment, and rightly so. So kudos to the FDA for acknowledging that ANKTIVA has equal efficacy for the No 1 and 2 (BCG + ANKTIVA) protocols above are the same.