YESCARTA® (axicabtagene ciloleucel) Clinical Trial Results

How has YESCARTA been studied?

YESCARTA has been studied across multiple clinical trials to look at how well it works, how safe it is, and who it might help. The FDA has approved YESCARTA for multiple uses based on the outcomes of these trials.

What are the results from the clinical trials?

Three key clinical trials looked at how YESCARTA works for adult patients with different types of relapsed/refractory (R/R) cancer and treatment histories.

Click below to see the clinical trial results for the cancer type you want to learn more about:

Trial in LBCL (2^nd line)

Adult patients with Large B-Cell Lymphoma who have tried one previous treatment that didn't work or the cancer came back within 12 months

Trial in LBCL (3^rd line)

Adult patients with Large B-Cell Lymphoma who have tried two or more previous treatments that didn't work or the cancer came back

Trial in FL (3^rd line)

Adult patients with Follicular Lymphoma who have tried two or more previous treatments that didn't work or the cancer came back

Talk to your healthcare team if you want to learn more about the clinical trial results for your type of blood cancer.

There are ongoing clinical trials to see if YESCARTA can be used safely and effectively in other situations.

“My post-CAR T scan showed I was officially in remission! It was a day I had hoped for but feared wouldn’t come. A couple of weeks after that I felt the weight lift from my shoulders.”

LayraYESCARTA Patient

This testimonial is representative of the patient’s own experience. Individual treatment results and experience may vary.

Where can I learn more about the possible side effects of YESCARTA?

Patients in YESCARTA clinical trials also experienced side effects. You can learn more about these side effects by:

reading the Important Safety Information.
visiting the Managing side effects page to learn more about how to look out for side effects.
talking to your treatment team.

Have questions? Call us

Your treatment team is the best resource for support throughout treatment.

If you have questions at any step of the CAR T process, our dedicated team at Kite can also help. You can call them at:

1-844-454-KITE [5483]5483

Monday–Friday 8 am–9 pm ET 5 am–6 pm PT

Trial in LBCL (2^nd line)

Adult patients with Large B-Cell Lymphoma who have tried one previous treatment, and:

it didn't work, or
their cancer came back within 12 months

Trial goal

The purpose of this trial was to see if YESCARTA improved the clinical outcome for patients when compared to standard therapy.

People in the trial

A total of 359 adult patients were randomly assigned to one of two treatment groups.

180 patients received YESCARTA, and 179 patients received standard therapy.^*

*Standard therapy in this trial included chemotherapy, high-dose therapy, and autologous stem cell transplant, depending on how the cancer responded to treatment.

359 patients randomly assigned to treatment groups.

180 patients received YESCARTA, and 179 patients received standard therapy.^*

*Standard therapy in this trial included chemotherapy, high-dose therapy, and autologous stem cell transplant, depending on how the cancer responded to treatment.

2 years after treatment, patients who received YESCARTA were more than twice as likely to stay event free compared to standard therapy*

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4 years after treatment, YESCARTA patients had a 27.4% reduction in risk of death compared to standard therapy.* This corresponds to a 38% relative improvement in overall survival.

This makes YESCARTA the first and only treatment in nearly 30 years to show significant improvement in Overall Survival (OS)

These results were collected in a follow-up analysis 5 years after the trial began. They are not included in the Prescribing Information for YESCARTA. Your experience may vary.

Overall Survival is the length of time that a patient remains alive after receiving a treatment.

Patients had a 56% chance of still being alive at 39 months with YESCARTA

46% chance of still being alive at 39 months with standard therapy*

These results were collected in a follow-up analysis 5 years after the trial began. They are not included in the Prescribing Information for YESCARTA. Your experience may vary.

See the data expand_more

For half of the YESCARTA patients in this trial, their CAR T cells arrived at the certified treatment center within 18 days of T cell collection

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*Standard therapy in this trial included chemotherapy, high-dose therapy, and autologous stem cell transplant, depending on how the cancer responded to treatment.

Trial in LBCL (3^rd line)

Adult patients with Large B-Cell Lymphoma who tried two previous treatments, and:

they didn't work, or
their cancer came back

Trial goal

The purpose of this trial was to understand how well YESCARTA works and the risks that come with it.

People in the trial

A total of 101 adult patients participated and received YESCARTA.

Roughly 7 in 10 patients saw a partial or complete remission

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Half of the patients who saw partial or complete remission did so within approximately 1 month of treatment

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Most patients with a complete response were still in remission 2 years after treatment

For half of the patients in this trial, their CAR T cells arrived at the certified treatment center within 17 days of T cell collection

See the data expand_more

Approved Uses

YESCARTA is a prescription medicine used to treat two types of non-Hodgkin lymphoma ...

Important Safety Information

What is the most important information I should know about YESCARTA? YESCARTA may cause side effects that are life-threatening and can lead to death ...

Approved Uses and Important Safety Information

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Closelast_page

Approved Uses

YESCARTA is a prescription medicine used to treat two types of non-Hodgkin lymphoma:

large B-cell lymphoma when your first treatment did not work or your cancer returned within a year of first treatment, OR when at least two kinds of treatment have failed to control your cancer.
follicular lymphoma when at least two kinds of treatment have failed to control your cancer.

YESCARTA is different than other cancer medicines because it is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells.

Important Safety Information

What is the most important information I should know about YESCARTA?

YESCARTA may cause side effects that are life-threatening and can lead to death. Call or see your healthcare provider or get emergency help right away if you get any of the following:

Fever (100.4°F/38°C or higher)
Difficulty breathing
Chills or shaking chills
Confusion
Dizziness or lightheadedness
Severe nausea, vomiting, or diarrhea
Fast or irregular heartbeat
Severe fatigue or weakness

It is important to tell your healthcare provider that you received YESCARTA and to show them your YESCARTA Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.

Before getting YESCARTA, tell your healthcare provider about all your medical problems, including if you have or have had:

Neurologic problems (such as seizures, stroke, or memory loss)
Lung or breathing problems
Heart problems
Liver problems
Kidney problems
A recent or active infection

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive YESCARTA?

Since YESCARTA is made from your own white blood cells, your blood will be collected by a process called “leukapheresis” (loo-kah-fur-ee-sis), which will concentrate your white blood cells.
Your blood cells will be sent to a manufacturing center to make your YESCARTA.
Before you get YESCARTA, you will get 3 days of chemotherapy to prepare your body.
When your YESCARTA is ready, your healthcare provider will give it to you through a catheter placed into your vein (intravenous infusion). The infusion usually takes less than 30 minutes.
You will be monitored where you received your treatment daily for at least 7 days after the infusion.
You should plan to stay close to the location where you received your treatment for at least 4 weeks after getting YESCARTA. Your healthcare provider will help you with any side effects that may occur.
You may be hospitalized for side effects and your healthcare provider will discharge you if your side effects are under control, and it is safe for you to leave the hospital.
Your healthcare provider will want to do blood tests to follow your progress. It is important that you do have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.

What should I avoid after receiving YESCARTA?

Do not drive, operate heavy machinery, or do other dangerous things for 8 weeks after you get YESCARTA because the treatment can cause sleepiness, confusion, weakness, and temporary memory and coordination problems.
Do not donate blood, organs, tissues, or cells for transplantation.

What are the possible or reasonably likely side effects of YESCARTA?

The most common side effects of YESCARTA include:

Fever (100.4°F/38°C or higher)
Low white blood cells (can occur with a fever)
Low red blood cells
Low blood pressure (dizziness or lightheadedness, headache, feeling tired, short of breath)
Fast heartbeat
Confusion
Difficulty speaking or slurred speech
Nausea
Diarrhea

These are not all the possible side effects of YESCARTA. Call your healthcare provider about any side effects that concern you. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the Important Facts, including IMPORTANT WARNINGS.

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