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CARVYKTI highest risk of secondary cancers

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According to the research linked and excerpted below, Carvykti carries the highest risk of secondary cancers compared to all current CAR-T cell therapies.

To be clear, all CAR-T cell therapies carry a risk of secondary cancers. The study below simply determined that CARVYKTI secondary cancer risk is the highest of all current CAR-T cell therapies (as of 102024)

Therefore, the point of this post is not to focus on CAR-T cell therapy and secondary cancer risk but to focus on the many serious possible side effects of CAR-T cell therapies listed below.


What are the short and long-term side effects of of CARVYKTI CAR-T cell therapy for RR/MM patients?

Short-Term Side Effects

These typically occur within days to weeks after the infusion of CARVYKTI and can include:

  1. Cytokine Release Syndrome (CRS):
    • CRS is the most common side effect of CAR-T cell therapy, occurring in a majority of patients. It is caused by the release of large amounts of cytokines (immune system proteins) from the activated T cells.
    • Symptoms: High fever, fatigue, nausea, low blood pressure, difficulty breathing, rapid heart rate, and multi-organ dysfunction in severe cases.
    • Onset: Usually within the first week, typically around days 7–10 post-infusion.
    • Management: CRS is often treated with tocilizumab (an anti-IL-6 receptor antibody) and steroids.
  2. Neurotoxicity (ICANS – Immune Effector Cell-Associated Neurotoxicity Syndrome):
    • Neurotoxicity, which includes confusion, difficulty speaking, seizures, and encephalopathy, is another significant short-term risk.
    • Symptoms: Headaches, tremors, confusion, delirium, difficulty writing or speaking, and in rare cases, coma.
    • Onset: Typically occurs within a week to two after the CAR-T infusion.
    • Management: Corticosteroids and other supportive care measures.
  3. Infections:
    • The immune system is suppressed following CAR-T therapy, increasing the risk of infections.
    • Bacterial, viral, and fungal infections are common, especially early post-treatment when patients are still recovering from the chemotherapy used for lymphodepletion prior to the CAR-T cell infusion.
  4. Low Blood Counts:
    • Patients often experience prolonged cytopenias (low levels of red and white blood cells, and platelets) following CAR-T therapy. This can lead to anemia, increased risk of infections (due to neutropenia), and bleeding complications.
    • Recovery from cytopenias can take weeks to months.
  5. Fatigue:
    • Severe fatigue is common and can persist for several weeks following treatment.
  6. Hypogammaglobulinemia:
    • A reduction in normal antibody levels can occur due to the targeting of B cells, which are involved in antibody production. This increases susceptibility to infections.

Long-Term Side Effects

Long-term side effects may persist for months to years after CARVYKTI infusion.

  1. Persistent Cytopenias:
    • While cytopenias are a short-term side effect, in some patients, these can persist long-term, especially for those who have undergone extensive prior therapies that may have already weakened their bone marrow.
  2. Secondary Malignancies:
    • Although rare, there is a potential long-term risk of developing secondary cancers after CAR-T therapy due to the genetic modifications made to the T cells. This risk, however, remains under study, and long-term follow-up is needed.
  3. Hypogammaglobulinemia (chronic):
    • Long-term hypogammaglobulinemia may require immunoglobulin replacement therapy to help prevent recurrent infections.
  4. Reactivation of Viral Infections:
    • Immunosuppression from CAR-T therapy can lead to the reactivation of latent viruses, such as cytomegalovirus (CMV) or Epstein-Barr virus (EBV).
  5. Chronic Fatigue and Neurological Issues:
    • Some patients may experience prolonged fatigue and lingering neurological symptoms, including mild cognitive deficits or mood changes, although these tend to improve over time in most cases.
  6. B Cell Aplasia:
    • CAR-T cell therapy may cause long-term B cell aplasia, where B cells (responsible for antibody production) are reduced or absent, potentially necessitating regular immunoglobulin replacement therapy for infection prevention.

In my experience as a newly diagnosed MM patient, oncology did a poor job of explaining the risks and possible rewards of my many therapies. 

This is my opinion but unless you have no other reasonable therapy choices, CAR-T cell therapy is really risky. Full of potential but risky.

Email me at David.PeopleBeatingCancer@gmail.com if have questions about both conventional and non-conventional MM therapies.

Hang in tere,

David Emerson

  • MM Survivor
  • MM Cancer Coach
  • Director PeopleBeatingCancer

One in Twenty Diagnosed with Secondary Cancer One Year After CAR T-Cell Therapy

Key Findings

  • 5.2% of patients who have undergone CAR T-cell therapy develop secondary cancer within a year, including both metastatic cancers and second primary cancers, with small variations by medication. 
  • Skin, respiratory organ, and digestive organ cancers were the most common types of secondary cancer after CAR T-cell therapy…

Chimeric antigen receptor (CAR) T-cell therapy is a type of immunotherapy that uses altered T cells to fight cancers such as lymphoma, leukemia, and multiple myeloma when other treatments have not been successful.1

In April 2024, the U.S. Food and Drug Administration (FDA) required a boxed warning for the risk of T-cell malignancies following CAR T-cell therapy and recommended lifelong monitoring for secondary cancers.2 However, others have reported that secondary cancers after CAR T-cell therapy are rare.3,4

To understand the rate of secondary cancer among patients who received CAR T-cell therapy, we studied 3,296 patients treated with CAR T-cell therapy between January 1, 2017, and August 1, 2023. Secondary cancers included both metastatic cancers and second primary cancers. Overall, we found that 5.2% of treated patients had a new cancer diagnoses three weeks to one year after the start of CAR T-cell therapy, as seen in Figure 1. When we stratified the data by the specific CAR T-cell therapy, we found small variations in the rate of secondary cancer, though no specific treatment was significantly different from the overall rate…

FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma

“Ciltacabtagene autoleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. Each dose is customized using a patient’s own T-cells, which are collected and genetically modified, and infused back into the patient…

The most common adverse reactions with ciltacabtagene autoleucel were pyrexia, cytokine release syndrome, hypogammaglobulinemia, musculoskeletal pain, fatigue, infections, diarrhea, nausea, encephalopathy, headache, coagulopathy, constipation, and vomiting…

Carvykti carries the highest risk of secondary cancers

 

 

 

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