Health

Yescarta Target B Cells

February 24, 2023
Jessica Anderson

Yescarta Target (axicabtagene ciloleucel) is a type of CAR T cell therapy that is used to treat certain types of non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL). The target of Yescarta is a protein called CD19, which is found on the surface of B cells, the type of cell that is often affected in NHL. YESCARTA uses an anti-CD19 extracellular domain to Yescarta target and bind to CD19 on the surface of healthy and cancerous B cells.

You Will Learn:

  • About Yescarta Therapy
  • How Yescarta Works
  • FDA Approval
  • Cost of Yescarta
  • Yescarta Side Effects

About Yescarta

CAR T cell therapy works by genetically modifying a patient’s T cells to recognize and attack cancer cells. In the case of Yescarta, the patient’s T cells are engineered to target CD19 on the surface of B cells. The modified T cells are then infused back into the patient, where they can seek out and destroy cancer cells.

CD19 is a common target for CAR T cell therapies in the treatment of NHL, as it is present on the surface of almost all B cells, including those that have become cancerous. By targeting CD19, CAR T cell therapies like Yescarta can effectively target cancer cells while sparing healthy cells.

How Yescarta Works

Yescarta (axicabtagene ciloleucel) is a type of CAR T cell therapy that works by genetically modifying a patient’s T cells to recognize and attack cancer cells.

Here’s how it works:

  1. Collection of T cells: The process begins with the collection of the patient’s T cells through a process called leukapheresis. The T cells are then sent to a laboratory, where they are genetically modified to express a chimeric antigen receptor (CAR).
  2. Genetic modification of T cells: The CAR is designed to recognize a protein called CD19, which is found on the surface of B cells, including those that have become cancerous. The CAR is made up of several components, including an antigen-binding domain, which is responsible for recognizing CD19, and a signaling domain, which activates the T cell when it binds to CD19.
  3. Expansion of CAR T cells: The genetically modified T cells are then cultured in the laboratory to expand their numbers. This process can take several days to a few weeks.
  4. Infusion of CAR T cells: Once the CAR T cells have been expanded, they are infused back into the patient’s bloodstream. The CAR T cells can then seek out and destroy cancer cells that express CD19.
  5. Destruction of cancer cells: Once the CAR T cells encounter a CD19-expressing cancer cell, they bind to the cell and become activated. This activation triggers the CAR T cell to release cytotoxic molecules, such as perforin and granzyme, which can cause the cancer cell to undergo programmed cell death, or apoptosis.

The goal of Yescarta is to eliminate cancer cells and achieve remission, which is a period of time when there is no evidence of cancer in the body. While CAR T cell therapy has shown promising results in clinical trials, it is not without risks, including cytokine release syndrome (CRS) and neurological side effects. It is important for patients to be closely monitored during and after treatment to manage these potential side effects.

Yescarta FDA Approval

Yescarta (axicabtagene ciloleucel) was approved by the U.S. Food and Drug Administration (FDA) in October 2017 for the treatment of adults with certain types of relapsed or refractory non-Hodgkin lymphoma (NHL), specifically diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL). This was the second CAR T cell therapy to be approved by the FDA, following the approval of Kymriah (tisagenlecleucel) for the treatment of pediatric acute lymphoblastic leukemia in August 2017.

The approval of Yescarta was based on the results of a clinical trial that included 101 patients with relapsed or refractory DLBCL or PMBCL who had not responded to or had relapsed after at least two prior treatments. The trial showed that 51% of patients treated with Yescarta achieved complete remission, meaning that their cancer disappeared completely, while another 21% achieved partial remission, meaning that their cancer shrank significantly. The overall response rate was 72%.

The FDA granted Yescarta accelerated approval, which is a type of approval given to drugs for serious conditions that fill an unmet medical need based on a surrogate endpoint, such as tumor shrinkage, that is reasonably likely to predict clinical benefit. The manufacturer of Yescarta, Kite Pharma, was required to conduct a post-marketing study to confirm the clinical benefit of Yescarta in patients with DLBCL.

Yescarta has since been approved in other countries, including the European Union, Canada, and Japan, for the treatment of certain types of NHL.

Yescarta Cost

The cost of Yescarta (axicabtagene ciloleucel) can vary depending on a number of factors, including the location of treatment, the individual patient’s health insurance coverage, and the specific details of the patient’s treatment plan. However, Yescarta is generally considered to be a very expensive therapy, with a list price of $373,000 for a one-time infusion in the United States.

The cost of Yescarta is a reflection of the complex and costly process involved in producing and administering the therapy. The process requires collecting the patient’s T cells through leukapheresis, genetically modifying them in a laboratory, and then expanding and infusing them back into the patient. Additionally, the therapy is administered in a hospital setting and requires close monitoring of the patient for potential side effects.

To help patients access this therapy, Kite Pharma (the manufacturer of Yescarta) has established a patient support program called Yescarta CARES (Cellular Activation and Expansion for Reinfusion of Autologous T-cells). The program provides assistance with insurance and financial support, as well as guidance on the treatment process and access to resources for managing potential side effects.

Patients and their caregivers should speak with their healthcare team and insurance provider to understand the costs and coverage associated with Yescarta, as well as any financial assistance programs that may be available.

Yescarta Side Effect

Like any medical treatment, Yescarta (axicabtagene ciloleucel) can cause side effects. The most common side effects of Yescarta are related to the immune response triggered by the therapy, and can include:

  1. Cytokine release syndrome (CRS): CRS is a systemic inflammatory response that can occur when CAR T cells are activated and release large amounts of cytokines into the bloodstream. Symptoms of CRS can include fever, flu-like symptoms, low blood pressure, rapid heartbeat, and difficulty breathing. CRS can range from mild to severe, and severe cases may require hospitalization.
  2. Neurological toxicity: Neurological toxicity can occur when CAR T cells enter the central nervous system and cause inflammation or other damage. Symptoms can include confusion, agitation, delirium, seizures, and difficulty speaking or moving.
  3. Infections: Because Yescarta targets B cells, which play a key role in the immune response, patients may be at increased risk of infection after treatment. Patients are often given antibiotics and antiviral medications to help prevent infections.
  4. Other side effects: Other side effects of Yescarta can include fatigue, decreased appetite, muscle and joint pain, and low blood cell counts.

It’s important to note that not all patients will experience these side effects, and the severity of side effects can vary from patient to patient. However, patients receiving Yescarta should be monitored closely for signs of these and other side effects, and should seek medical attention if they experience any concerning symptoms.

Patients and their caregivers should speak with their healthcare team to understand the potential risks and benefits of Yescarta, as well as strategies for managing and preventing potential side effects.

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