Kymriah™ (tisagenlecleucel)

Roswell Park Comprehensive Cancer Center is an authorized treatment center for Kymriah™ (tisagenlecleucel).

What is Kymriah™ (tisagenlecleucel)?

Kymriah is an FDA-approved immunotherapy — a treatment designed to help your own immune system fight cancer. Specifically, it is a type of chimeric antigen receptor (CAR) T-cell therapy. It strengthens and multiplies your T cells, the special white blood cells in your body that have the power to destroy cancer cells.

Who is eligible?

Kymriah is for:

• Patients 25 and younger who have been diagnosed with acute lymphoblastic leukemia (ALL) that has either relapsed (gone into remission and then returned) or is refractory (has not gone into remission despite treatment).
• Adults with large B-cell lymphoma that has either relapsed (gone into remission and then returned) or is refractory (has not gone into remission despite treatment).

In addition, the Roswell Park team must determine whether the patient is well enough to undergo this type of immunotherapy.

How does Kymriah work?

First, some of your T cells are collected through leukapheresis, an outpatient procedure that is very much like donating blood. The cells are sent to a laboratory, where a gene is added to strengthen their ability to find and kill cancer cells. The cells are then multiplied to become millions and millions of cancer-fighting T cells before they are sent back to Roswell Park. This process usually takes about three to four weeks.

In the meantime, you may receive chemotherapy for a few days to make room in your body for the new, stronger immune cells. Your Roswell Park team then gives the re-engineered cells back to you intravenously (through an IV).

You will be watched closely for at least seven days afterward so that the team can identify any side effects and step in quickly to manage them. For at least four weeks after receiving Kymriah, you should stay near Roswell Park for continued monitoring. (Some hotels and medical hospitality houses in Buffalo offer special lodging rates for out-of-town patients who travel to Roswell Park for treatment.)

What have clinical trials shown about Kymriah?

The FDA approves new treatments based on the results of clinical trials — research studies in which the treatments are given to patient volunteers for the very first time.

The clinical trials that led to FDA approval of Kymriah for acute lymphoblastic leukemia showed that of 63 participants, 83% (52 patients) experienced complete remission (no evidence of cancer) within three months of treatment.

The “II JULIET” clinical trial that led to FDA approval of Kymriah for large B-cell lymphoma showed that of 106 participants, 32% experienced complete remission, while another 18% experienced partial remission.

What are the side effects of Kymriah?

The most common side effect of CAR T-cell immunotherapy, cytokine release syndrome (CRS), occurs when there is a very strong response by the immune system. Patients may experience flu-like symptoms (fever, chills, joint pain, nausea, vomiting and diarrhea) as well as low blood pressure, difficulty breathing, dizziness and confusion. Although the symptoms are mild in most patients, in some cases, CRS may be serious and even life-threatening. Patients may also experience serious neurological reactions. Your Roswell Park team will discuss these side effects with you before you begin treatment.

In most cases, serious side effects occur within four weeks after treatment. You will need to stay close to Roswell Park for several weeks so you can be watched closely for signs of these side effects and they can be treated immediately.

What sets Roswell Park apart?

• Patients who receive CAR T-cell therapy should be treated at our Transplant and Cellular Therapy (TCT) Center where members of the medical team have significant experience in recognizing and managing the side effects of immunotherapies. Our team includes national leaders who helped develop the guidelines for managing the side effects of cellular therapies.
• The Foundation for the Accreditation of Cellular Therapy (FACT) has accredited Roswell Park as both an adoptive cellular therapy program and a bone marrow transplant (BMT) program. This indicates that Roswell Park adheres to strict standards and works constantly to achieve the best patient outcomes.
• Every patient who comes here for cellular therapy is monitored by a team of experts. The team meets every week, monitoring the patient’s status to ensure the best possible care.

Will my insurance cover Kymriah?

Kymriah is covered by many major health plans, including New York State Medicaid. Please contact your insurer directly to find out whether or not it is included in your specific plan.

What if I’m not eligible for Kymriah?

Our experts can identify all the options available to you, including any FDA-approved therapies and new treatments offered through clinical trials. Roswell Park is one of very few centers in the United States equipped to offer clinical trials of a full range of immunotherapies, including many that were developed right here. We are home to one of the largest phase I clinical trials programs in New York State.