CAR T-cell Therapy for Follicular Lymphoma

In May 2022, the Food and Drug Administration (FDA) approved tisagenlecleucel (tisa-cel, Kymriah) as a new CAR-T cell therapy for adults with follicular lymphoma. This marks a significant step forward, making tisa-cel the second CAR-T therapy option available in the US for this type of lymphoma.

What is CAR-T Therapy?

CAR-T stands for Chimeric Antigen Receptor T-cell therapy. It's a personalized treatment that harnesses a patient's own immune system to destroy the cancer cells. Here's a simplified breakdown:

1. From a sample of your blood, they extract your T cells.
2. In a lab, they modify the T cells to recognize and attack cancer cells.
3. The modified T cells (CAR-T cells) are grown in large numbers.
4. The CAR-T cells are infused back into your body, and they start acting against the cancer cells.

This new type of therapy is being used to treat patients with follicular lymphoma whose cancer has come back (relapsed) or hasn't responded well to previous treatments (refractory). Studies have shown that CAR-T therapies can lead to complete remission (no detectable cancer) in a high percentage of patients. This is a major advancement compared to traditional therapies, where the goal is often to manage the disease and prevent progression.

CAR-T Therapies Approved to Treat Follicular Lymphoma

Tisa-cel joins another FDA-approved CAR-T therapy for follicular lymphoma: axicabtagene ciloleucel (axi-cel, Yescarta). Both treatments target a protein called CD19 present on lymphoma cells, and have reported high rates of cancer remission with only one infusion. However, they have different safety considerations, and some patients may respond better to one over the others. It's important to consult your doctor to understand which CAR-T therapy might be the best fit for your specific situation.

Tisa-Cel Clinical Trial Results

The ELARA trial (NCT03568461) was a clinical study that evaluated the effectiveness and safety of tisa-cel in adults with relapsed or refractory follicular lymphoma. Patients who participated were followed for at least 24 months. Some of the key outcomes were:

• Complete Response (CR): This means no detectable cancer cells were found after treatment. The ELARA trial showed that nearly 70% of patients achieved CR, indicating a very positive response to tisa-cel.
• Overall Response Rate (ORR): This includes both total remission and tumor shrinkage (partial response). The ELARA trial showed that over 86% of patients had some level of positive response to tisa-cel treatment.

Side Effects of Tisa-Cel Therapy

The ELARA trial reported some potential side effects associated with the therapy. These are typically temporary and manageable with medication and close monitoring by a doctor. Some common side effects include:

• Fever and chills (cytokine release syndrome) were reported in 48.5% of patients
• Nervous system problems (headaches, confusion), experienced by 37.1% of patients
• Infections
• Fatigue
• Muscle pain
• Diarrhea

It's important to note that no treatment-related deaths were reported in the trial.

The ELARA trial results suggest that tisa-cel is a promising and potentially effective treatment option for adults with relapsed or refractory follicular lymphoma. The high response rates observed in the trial offer hope for patients who haven't had success with other treatments; the FDA approved tisa-cel based on these results. However, tisa-cel is still being evaluated for long-term efficacy and safety, and the FDA will monitor any new findings.

The CAR-T Revolution in Follicular Lymphoma

The success of CAR-T therapies is a major breakthrough in follicular lymphoma treatment. Researchers are actively exploring ways to further improve CAR-T therapies and make them even more effective for a broader range of patients.

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Sources: 

• FDA approves tisagenlecleucel for relapsed or refractory follicular lymphoma
• CAR-T Cell Therapy for Follicular Lymphomas