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What does the US FDA approval of Anktiva® signify for bladder cancer care?

Drug approvals Genitourinary Opinion
Anktiva

The US FDA recently approved Anktiva® (N-803), a first-of-its-kind immunotherapy, in combination with BCG for the treatment of non-muscle-invasive bladder cancer (NMIBC). In this interview, we speak with Karim Chamie (UCLA, CA, USA) to discover the importance of IL-15 in NMIBC and how this links with Anktiva’s mechanism of action. Chamie also provides a bitesize breakdown of key results from the trial evaluating its efficacy and safety – the QUILT 3.032 study.

What are the current treatment options for non-muscle-invasive bladder cancer?

Current treatment options for NMIBC include surgery to remove the tumors, followed by treatment with Bacillus Calmette-Guerin (BCG) and chemotherapy. However, BCG does not work for everyone, and those who initially respond often experience recurrence, leading to more radical surgery like removing the entire bladder. Anktiva offers another treatment option before bladder removal, which is administered intravesically in combination with BCG.

Why is IL-15 important in the treatment of this cancer type?

IL-15, or Interleukin-15, plays a crucial role in the body’s immune response against cancer cells, particularly in the treatment of non-muscle-invasive bladder cancer. Anktiva, which is an IL-15 superagonist, harnesses the power of IL-15 to activate the body’s natural killer (NK) cells and cytotoxic T lymphocytes, which are essential components of the immune system that target and destroy cancer cells.

The importance of IL-15 in this context lies in its ability to stimulate a robust and sustained immune response. Unlike other treatments that may offer temporary response, Anktiva’s activation of memory T cells can lead to a long-lasting response, with some patients experiencing complete responses that extend beyond 47 months. This prolonged effect is particularly significant because it suggests the potential for long-term remission in patients treated with Anktiva.

Furthermore, IL-15’s role in enhancing the immune system’s ability to fight cancer is a promising development in cancer immunotherapy, offering hope for more effective and durable treatments for NMIBC and potentially other types of cancer as well.

Can you provide a breakdown of key results from the QUILT 3.032 study?

Here’s a breakdown of the pivotal results:

  • Efficacy: The study demonstrated that Anktiva, when used in conjunction with BCG, significantly activated the body’s immune response against NMIBC. This was evidenced by the activation of natural killer cells and cytotoxic T-lymphocytes, which are crucial for targeting and destroying cancer cells.
  • Duration of Response: Anktiva’s impact on the immune system was not only potent but also enduring. Patients treated with Anktiva showed a long duration of complete response, with some cases exceeding 47 months. This suggests that Anktiva can potentially offer long-term remission for patients with NMIBC.
  • Clinical Significance: The percentage of patients with durable responses at 12 and 24 months surpassed the benchmarks established by the International Bladder Cancer Group (IBCG), indicating a significant advancement in the treatment of NMIBC.
  • Safety Profile: Anktiva was well-tolerated by patients, with a safety profile that was consistent with its mechanism of action. This is crucial for patient compliance and the overall success of the treatment regimen.

Overall, the QUILT 3.032 study’s results are promising, showing that Anktiva could be a game-changer in the treatment of NMIBC, offering a new hope for patients who are unresponsive to the current standard of care.

Which research areas should be focused on to advance bladder cancer treatment in the next decade?

Our intravesical therapies (immunotherapy and chemotherapy) are far too blunt and don’t integrate each patient’s specific tumor with a particular treatment type. Additional profiling of the tumor so that we may be able to integrate an immune response with a more personalized target.

Interviewee profile: karim chamie Dr Karim Chamie is an Associate Professor of Urology at UCLA. He attended Medical School at USC and completed Urological training at UC Davis. Dr Chamie then completed an SUO-certified fellowship in Urologic Oncology at UCLA. His primary research interests are health services research and clinical trials in bladder cancer. His clinical interests include all areas of urologic oncology, with a particular emphasis on bladder cancer and robotic surgery.

 

The opinions expressed in this article are those of the author and do not necessarily reflect the views of Oncology Central or Taylor & Francis Group.