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Related Concept Videos

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Tumor Immunotherapy

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Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
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The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
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Twelve-Month Results From the CISTO Study Comparing Radical Cystectomy Versus Bladder-Sparing Therapy for Recurrent High-Grade Non-Muscle-Invasive Bladder Cancer.

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IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer.

Karim Chamie1, Sam S Chang2, Eugene Kramolowsky3

  • 1Department of Urology, UCLA Medical Center, Los Angeles.

NEJM Evidence
|February 6, 2024
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Summary
This summary is machine-generated.

Nogapendekin alfa inbakicept (NAI) combined with BCG shows promise for BCG-unresponsive bladder cancer, achieving complete responses and high survival rates. This combination therapy offers a potential new option for patients with limited treatment alternatives.

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Area of Science:

  • Urology
  • Oncology
  • Immunotherapy

Background:

  • Non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette–Guérin (BCG) presents limited therapeutic avenues.
  • Interleukin-15 (IL-15) superagonist Nogapendekin alfa inbakicept (NAI) may enhance BCG efficacy through immune activation.

Purpose of the Study:

  • To evaluate the efficacy and safety of intravesical NAI combined with BCG in patients with BCG-unresponsive NMIBC.
  • To assess complete response (CR) rates, durability, and survival outcomes.

Main Methods:

  • An open-label, multicenter study involving patients with BCG-unresponsive carcinoma in situ (CIS) or papillary NMIBC.
  • Treatment arms included intravesical NAI plus BCG (cohort A) or NAI alone (cohort C), and NAI plus BCG for high-grade Ta/T1 NMIBC (cohort B).
  • Primary endpoints were CR at 3- or 6-month visits (cohorts A/C) and disease-free survival (DFS) at 12 months (cohort B).

Main Results:

  • Cohort A (NAI + BCG) achieved a 71% CR rate at 3- or 6-month visits, with a median CR duration of 26.6 months.
  • At 24 months, patients in CR demonstrated an 89.2% probability of avoiding cystectomy and 100% disease-specific survival (DSS).
  • Cohort B (high-grade Ta/T1 NMIBC) showed a 12-month DFS rate of 55.4% with NAI + BCG.

Conclusions:

  • Combination therapy with NAI and BCG demonstrates significant efficacy in BCG-unresponsive NMIBC, including CIS.
  • The treatment leads to durable complete responses, high rates of cystectomy avoidance, and excellent bladder cancer-specific survival.
  • NAI plus BCG represents a promising novel therapeutic strategy for patients with challenging NMIBC.