Your cells. Your results.

Clinical trial results Side effects

Clinical trial results Side effects

In the AMTAGVI™ clinical trial:

73 people were treated with AMTAGVI
Patients had received a Median:
Median is the midpoint in a range of numbers, where half of the numbers are below, and half are above that number. of 3 prior therapies, including a PD-1 inhibitor
People who were BRAF V600 mutation positive previously received a BRAF inhibitor with or without a MEK inhibitor

Clinical trial results

Treatment outcomes: Objective response rate: 29% out of 87 people responded to AMTAGVI.

Objective response rate:
The percentage of people whose cancer shrinks or is not detectable after treatment for a given time period.

27%, or 20 out of 73 people, had a Partial response:
When a treatment causes a decrease in tumor size or in the amount of tumor found in the body., meaning their tumors shrank
4%, or 3 out of 73 people, had a Complete response:
When a treatment causes the disappearance of all signs of cancer. This does not always mean the cancer has been cured., meaning their tumors disappeared completely or became undetectable

This does not always mean that the cancer was cured.

Median time to first response

The median time to response was 6 weeks

This means that half of responses were seen at 6 weeks and half were seen after.

One-time AMTAGVI treatment may not work for everyone. Individual results may vary. Talk to your healthcare team to learn if AMTAGVI may be right for you.

Side effects

Common side effects with AMTAGVI in the clinical trial

The most common side effects associated with AMTAGVI treatment:

Chills
Fever
Low white blood cells
Tiredness (fatigue)
Low red blood cells (anemia)
Fast or irregular heartbeat
Rash
Low blood pressure
Diarrhea

These are not all the possible side effects associated with AMTAGVI treatment. Speak with your healthcare team immediately if you experience any side effects.

You may report side effects to Iovance at 1-833-400-IOVA (4682), or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Details about the AMTAGVI treatment process

LEARN MORE ABOUT RECEIVING AMTAGVI

AMTAGVI is available at
Authorized Treatment Centers

Find a center near you

Useful tools and resources for your treatment journey

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What is AMTAGVI (lifileucel)?

AMTAGVI is a prescription medicine used to treat adults with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma.

AMTAGVI is used when your melanoma has not responded or stopped responding to a PD-1 blocking drug either by itself or in a combination, and if your cancer is BRAF mutation positive, a BRAF inhibitor drug with or without a MEK inhibitor drug that has also stopped working.

The approval of AMTAGVI is based on a study that measured response rate. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

Please see accompanying Full Prescribing Information and Patient Information, including BOXED WARNINGS, for additional Important Safety Information.

Important Safety Information

AMTAGVI is associated with serious and potentially life-threatening or fatal side effects, including treatment-related death, prolonged severe low blood cell counts (cytopenia), serious infections, and cardiopulmonary (heart, lung) and renal (kidney) impairment. Your healthcare provider will monitor you for these side effects during treatment.

What is the most important information that I should know about AMTAGVI?

You will likely be in a hospital prior to and after receiving AMTAGVI.

Before taking AMTAGVI, tell your healthcare provider about all of your medical conditions, including if you:

Have any lung, heart, liver or kidney problems
Have low blood pressure
Have a recent or active infection or other inflammatory conditions including cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection
Are pregnant, think you may be pregnant, or plan to become pregnant
Are breastfeeding
Notice the symptoms of your cancer are getting worse
Have had a vaccination in the past 28 days or plan to have one in the next few months
Have been taking a blood thinner

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

How will I receive AMTAGVI?

AMTAGVI is made from your surgically removed tumor. Tumor derived T cells are grown in a manufacturing center at the end of which they number in the billions of cells.
Your tumor tissue is sent to a manufacturing center to make AMTAGVI. It takes about 34 days from the time your tumor tissue is received at the manufacturing center until AMTAGVI is available to be shipped back to your healthcare provider, but the time may vary. Your AMTAGVI will be provided in 1-4 patient-specific infusion bag(s) containing 100 mL to 125 mL of viable (alive) cells per bag.
After your AMTAGVI arrives at your treating institution, your healthcare provider will give you lymphodepleting chemotherapy to prepare your body.
Approximately 30 to 60 minutes before you are given AMTAGVI, you may be given other medicines including:
- Medicines for an allergic reaction (anti-histamines)
- Medicines for fever (such as acetaminophen)
Your AMTAGVI will be provided in 1 to 4 infusion bag(s) containing 100 mL to 125 mL of viable cells per bag. When your body is ready for AMTAGVI infusion, your healthcare provider will give AMTAGVI to you by intravenous infusion. This usually takes less than 90 minutes.

After getting AMTAGVI

Beginning 3 to 24 hours after AMTAGVI is given, you may be given up to 6 doses of IL-2 (aldesleukin) every 8 to 12 hours via intravenous infusion. Your doctor may discontinue IL-2 (aldesleukin) infusion any time if you have severe side effects.

You will have to stay in the hospital until you have completed the IL-2 (aldesleukin) treatment and you have recovered from any serious side effects associated with the AMTAGVI treatment.

You should plan to stay within 2 hours of the location where you received your treatment for several weeks after getting AMTAGVI. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur.

What are the possible side effects of AMTAGVI?

The most common side effects of the AMTAGVI treatment include chills, fever, low white blood cell count (may increase risk of infections), fatigue, low red blood cell count (may cause you to feel tired or weak), fast or irregular heartbeat, rash, low blood pressure, and diarrhea.

These are not all the possible side effects of the AMTAGVI treatment. Talk with your healthcare provider for more information about AMTAGVI. You can ask your healthcare provider for information about AMTAGVI that is written for healthcare professionals.

You may report side effects to Iovance at 1-833-400-46821-833-400-4682, or to the FDA, at 1-800-FDA-10881-800-FDA-1088 or at www.fda.gov/medwatch.

Please see accompanying Full Prescribing Information and Patient Information, including Boxed WARNINGS, for additional Important Safety Information.

What is AMTAGVI (lifileucel)?

AMTAGVI is a prescription medicine used to treat adults with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma.

AMTAGVI is used when your melanoma has not responded or stopped responding to a PD-1 blocking drug either by itself or in a combination, and if your cancer is BRAF mutation positive, a BRAF inhibitor drug with or without a MEK inhibitor drug that has also stopped working.

The approval of AMTAGVI is based on a study that measured response rate. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

Please see accompanying Full Prescribing Information and Patient Information, including BOXED WARNINGS, for additional Important Safety Information.

Important Safety Information

AMTAGVI is associated with serious and potentially life-threatening or fatal side effects, including treatment-related death, prolonged severe low blood cell counts (cytopenia), serious infections, and cardiopulmonary (heart, lung) and renal (kidney) impairment. Your healthcare provider will monitor you for these side effects during treatment.

What is the most important information that I should know about AMTAGVI?

You will likely be in a hospital prior to and after receiving AMTAGVI.

Before taking AMTAGVI, tell your healthcare provider about all of your medical conditions, including if you:

Have any lung, heart, liver or kidney problems
Have low blood pressure
Have a recent or active infection or other inflammatory conditions including cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection
Are pregnant, think you may be pregnant, or plan to become pregnant
Are breastfeeding
Notice the symptoms of your cancer are getting worse
Have had a vaccination in the past 28 days or plan to have one in the next few months
Have been taking a blood thinner

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

How will I receive AMTAGVI?

AMTAGVI is made from your surgically removed tumor. Tumor derived T cells are grown in a manufacturing center at the end of which they number in the billions of cells.
Your tumor tissue is sent to a manufacturing center to make AMTAGVI. It takes about 34 days from the time your tumor tissue is received at the manufacturing center until AMTAGVI is available to be shipped back to your healthcare provider, but the time may vary. Your AMTAGVI will be provided in 1-4 patient-specific infusion bag(s) containing 100 mL to 125 mL of viable (alive) cells per bag.
After your AMTAGVI arrives at your treating institution, your healthcare provider will give you lymphodepleting chemotherapy to prepare your body.
Approximately 30 to 60 minutes before you are given AMTAGVI, you may be given other medicines including:
- Medicines for an allergic reaction (anti-histamines)
- Medicines for fever (such as acetaminophen)
Your AMTAGVI will be provided in 1 to 4 infusion bag(s) containing 100 mL to 125 mL of viable cells per bag. When your body is ready for AMTAGVI infusion, your healthcare provider will give AMTAGVI to you by intravenous infusion. This usually takes less than 90 minutes.

After getting AMTAGVI

Beginning 3 to 24 hours after AMTAGVI is given, you may be given up to 6 doses of IL-2 (aldesleukin) every 8 to 12 hours via intravenous infusion. Your doctor may discontinue IL-2 (aldesleukin) infusion any time if you have severe side effects.

You will have to stay in the hospital until you have completed the IL-2 (aldesleukin) treatment and you have recovered from any serious side effects associated with the AMTAGVI treatment.

You should plan to stay within 2 hours of the location where you received your treatment for several weeks after getting AMTAGVI. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur.

What are the possible side effects of AMTAGVI?

The most common side effects of the AMTAGVI treatment include chills, fever, low white blood cell count (may increase risk of infections), fatigue, low red blood cell count (may cause you to feel tired or weak), fast or irregular heartbeat, rash, low blood pressure, and diarrhea.

These are not all the possible side effects of the AMTAGVI treatment. Talk with your healthcare provider for more information about AMTAGVI. You can ask your healthcare provider for information about AMTAGVI that is written for healthcare professionals.

You may report side effects to Iovance at 1-833-400-46821-833-400-4682, or to the FDA, at 1-800-FDA-10881-800-FDA-1088 or at www.fda.gov/medwatch.

Please see accompanying Full Prescribing Information and Patient Information, including Boxed WARNINGS, for additional Important Safety Information.