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.
For LBCL patients whose cancer returned after their first treatment: YESCARTA showed improved results compared to standard therapy.
Trial in LBCL (2nd line)
A clinical trial looked at 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 (also called 2nd line). The goal of this trial was to see if YESCARTA improved the clinical outcome for patients when compared to
standard therapy?. Standard therapy in this trial included chemoimmunotherapy,
high-dose therapy, and autologous stem cell transplant, depending on how the cancer responded to treatment.
What are the results from the other YESCARTA clinical trials?
Other 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:
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.
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:
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Certified treatment center locator tool
There are over 120 cancer centers certified to provide YESCARTA throughout the US. When choosing a location, consider that you will need to stay close to a center for at least 4 weeks after receiving YESCARTA.
You can use the locator tool to find and learn about nearby treatment centers and their teams.
Information on new centers (where available) will be added on an ongoing basis. You can also contact your treatment team to learn more.
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Certified treatment centers (also called Authorized Treatment Centers) are independent facilities certified to dispense Kite CAR T therapies. Choice of a certified treatment center is within the sole discretion of the physician and patient. Kite does not endorse any individual treatment sites. Insurance coverage should be considered when reviewing certified treatment center options.
Standard therapy
A standard therapy is a treatment that is accepted by doctors as a suitable and widely used treatment for a certain type of disease. Also called “standard of care.”
Trial in LBCL (2nd 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 chemoimmunotherapy, high-dose therapy, and autologous stem cell transplant, depending on how the cancer responded to treatment.
180 patients received YESCARTA, and 179 patients received standard therapy.*
*Standard therapy in this trial included chemoimmunotherapy, high-dose therapy, and autologous stem cell transplant, depending on how the cancer responded to treatment.
Two years after treatment, patients who received YESCARTA were more than twice as likely to stay event free compared to patients who received standard therapy.*
Event-free survival? is the length of time after treatment that patients go without having their cancer come back, get worse, or experience any other complications or worsening of symptoms.
Patients had a40.5%
chance of remaining event free at 2 years with YESCARTA
Patients had a16.3%
chance of remaining event free at 2 years with standard therapy*
It was also calculated that YESCARTA patients had a 60% reduced risk of the cancer coming back or getting worse compared to standard therapy* at 2 years after treatment.
Talk to your treatment team if you want to learn more about these numbers.
YESCARTA is the first and only approved CAR T treatment to show longer overall survival compared to standard therapy.*
Overall survival? is the length of time that patients remain alive after starting a treatment.
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.
It was also measured that, at 39 months after treatment:
Roughly 6 in 10 patients who received YESCARTA were alive (56% of patients)
Roughly 5 in 10 patients who received standard therapy* were alive (46% of patients)
Talk to your treatment team if you want to learn more about these numbers.
The median time of CAR T-cell delivery to the certified treatment center was 18 days for the YESCARTA patients in this trial. The median is the middle value in a set of measurements.
In this clinical trial, the median (or middle value) was calculated from a set of delivery times. CAR T-cell delivery to the treatment center ranged from 13 to 49 days after patients’ T cells were collected.
The CAR T-cell manufacturing process was successful for 100% of YESCARTA patients in this trial who started apheresis. The manufacturing process has maintained a
success rate of 96% overall since YESCARTA was first approved in 2017.
Talk to your treatment team if you want to learn more about these numbers.
*Standard therapy in this trial included chemoimmunotherapy, high-dose therapy, and autologous stem cell transplant, depending on how the cancer responded to treatment.
Trial in LBCL (3rd 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
72% or 73 of 101 patients saw a partial or complete remission
Roughly 5 in 10 patients sawcomplete remission(51% or 52 of 101 patients)
Roughly 2 in 10 patientssaw partial remission(21% or 21 of 101 patients)
Complete remission, also called complete response, is when all signs or symptoms of cancer have gone away. Complete remission does not always mean the cancer has been cured.
Partial remission, also called partial response, is when some signs and symptoms of cancer have gone away.
The median time to patients’ partial or complete remission after treatment was approximately 1 month. The median is the middle value in a set of measurements.
In this clinical trial, the median (or middle value) was calculated from a set of times to remission. Patients took between 0.8 and 6.2 months to achieve remission.
Most patients with a complete response were still in remission
2 years
after treatment
The median time of CAR T-cell delivery to the certified treatment center was 17 days for the YESCARTA patients in this trial. The median is the middle value in a set of measurements.
In this clinical trial, the median (or middle value) was calculated from a set of delivery times. CAR T-cell delivery to the treatment center ranged from 14 to 51 days after patients’ T cells were collected.
The CAR T-cell manufacturing process was successful for 99% of YESCARTA patients enrolled in this trial. The manufacturing process has maintained a success rate of 96% overall since YESCARTA was first approved in 2017.
Talk to your treatment team if you want to learn more about these numbers.
Overall survival (OS) is the length of time that patients remain alive after starting a treatment.
Researchers and doctors use overall survival data to help determine how well a treatment works.
Event-free survival
In clinical trials, an event is when a patient’s cancer comes back, gets worse, or experiences any other complications or worsening of symptoms.
Event free means a patient has not experienced an event.
Event-Free Survival (EFS) measures the length of time after treatment that patients go without having an event. Researchers and doctors use event-free survival data to help determine how well a treatment works.
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 ...
Adult patients with Follicular Lymphoma who tried two or more 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 81 adult patients participated and received YESCARTA.
Roughly 9 in 10 patients saw a partial or complete remission
91% or 74 of 81 patients saw a partial or complete remission
Roughly 6 in 10 patients sawcomplete remission(60% or 49 of 81 patients)
Roughly 3 in 10 patientssaw partial remission(31% or 25 of 81 patients)
Complete remission, also called complete response, is when all signs or symptoms of cancer have gone away. Complete remission does not always mean the cancer has been cured.
Partial remission, also called partial response, is when some signs and symptoms of cancer have gone away.
The median time to patients’ partial or complete remission after treatment was approximately 1 month. The median is the middle value in a set of measurements.
In this clinical trial, the median (or middle value) was calculated from a set of times to remission. Patients took between 0.8 and 3.1 months to achieve remission.
Most patients with a complete response were still in remission
1.5 years
after treatment
The median time of CAR T-cell delivery to the certified treatment center was 17 days for the YESCARTA patients in this trial. The median is the middle value in a set of measurements.
In this clinical trial, the median (or middle value) was calculated from a set of delivery times. CAR T-cell delivery to the treatment center ranged from 13 to 33 days after patients’ T cells were collected.
The CAR T-cell manufacturing process was successful for 100% of YESCARTA patients in this trial. The manufacturing process has maintained a success rate of 96% overall since YESCARTA was first approved in 2017.
Talk to your treatment team if you want to learn more about these numbers.
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 a certified healthcare facility 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
YESCARTA may increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.
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.
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