If you or a loved one has advanced melanoma, you may be considering different treatment options. One treatment you may hear about is Amtagvi (lifileucel), a type of immunotherapy called tumor-infiltrating lymphocyte (TIL) therapy.
Amtagvi received FDA approval in 2024 for certain adults with melanoma. Unlike most cancer medicines, Amtagvi is made for each person from immune cells found inside their own tumor. The cells are collected, grown into billions of cells in a lab, and then given back as a one-time treatment.
Continue reading this article to learn how Amtagvi works for melanoma, its benefits seen in studies, and how the process works. You may also want to read about Amtagvi side effects.
How Does Amtagvi Work for Melanoma?
Your immune system contains specialized white blood cells called T cells that help identify and attack abnormal cells. Some T cells can leave the bloodstream and enter a tumor. These cells are known as tumor-infiltrating lymphocytes, or TILs.
TILs have already found their way into the tumor and may recognize features, called antigens, on the cancer cells. However, the number or activity of these cells may not be enough to control the cancer on their own.
Amtagvi is made using these TILs. First, a small piece of your melanoma tumor is removed via surgery. The tumor tissue is then sent to a specialized facility, where T cells are separated from other cells. These are then grown into billions of cells. The finished Amtagvi treatment is frozen and shipped back to the treatment center, where it is given to you through an intravenous (IV) infusion.
In this way, Amtagvi gives your body a much larger number of T cells that came directly from your tumor and may be able to identify the melanoma.
Is Amtagvi Right for My Melanoma?
Amtagvi is FDA-approved for adults with melanoma that is unresectable (can’t be removed by surgery) or metastatic (has spread to other body parts) and has already been treated with certain other medicines.
Before receiving Amtagvi, you must have already been treated with a PD-1 blocking antibody for your melanoma. This is a type of immunotherapy that helps your immune system recognize and attack cancer.
If testing shows that your melanoma has a certain gene change (BRAF V600 mutation), you must also have previously received a BRAF inhibitor, either alone or with a MEK inhibitor. BRAF and MEK inhibitors are targeted medicines that interfere with signals that help melanoma cells with certain BRAF mutations grow.
Amtagvi is not a typical first treatment for melanoma. It can be an option when melanoma has continued to grow or stopped responding after these earlier treatments.
Amtagvi must be given at a treatment center with a health care team trained to provide this type of therapy. A health care provider can review your previous treatments, overall health, and other factors to decide whether Amtagvi may be an option for you.
How Do I Receive Amtagvi?
Amtagvi itself is given as a one-time IV infusion (into a vein), but the entire treatment process takes several weeks and involves several steps. Here is what the typical process looks like:
- Tumor collection and making Amtagvi. First, a surgeon removes a piece of your tumor. If you have more than one tumor, your treatment team will decide which one is best to use. The tissue is shipped to a specialized facility, where T cells are separated from the tumor and grown into billions of cells. It usually takes about 34 days to make Amtagvi once the tumor tissue arrives at the facility.
- Chemotherapy before Amtagvi. Before the infusion, you receive a short course of chemotherapy. This is done to temporarily reduce certain immune cells so that your body is ready for the new T cells. The standard regimen includes cyclophosphamide given through an IV once daily for two days, followed by IV fludarabine once daily for five days.
- Amtagvi infusion. Amtagvi is given in a hospital through an IV. The dose contains 7.5 billion to 72 billion living cells. The infusion itself usually takes less than 90 minutes.
- Interleukin-2 (IL-2) treatment. IL-2 is started 3-24 hours after Amtagvi to help support the T cells in your body. It is given every 8-12 hours for up to six doses.
Your treatment team will closely monitor you during the treatment. They will also give you instructions on how to prepare for treatment and what to expect before and after your infusion.
How Was Amtagvi Studied for Melanoma?
The effectiveness of Amtagvi was tested in the C-144-01 clinical study. The study included adults with melanoma that could not be removed with surgery or had spread to other parts of the body. Everyone had previously tried at least one or two treatments for their melanoma before joining the study.
People could not join the study if they had certain health conditions or used specific treatments, including:
- Uncontrolled brain metastases
- Previous organ transplant or cell-transfer therapy
- Melanoma that started in the eye
- Systemic steroid use
- Recent significant bleeding
- Certain heart or lung problems
A total of 111 people started the study and had tumor tissue surgically removed to make Amtagvi. Of these, 22 did not ultimately receive treatment because Amtagvi could not be successfully made from the tumor sample, their cancer worsened, or they had other health problems or changes.
Of the 89 people who received Amtagvi, the main analysis focused on 73 people who received Amtagvi within the recommended dose range of 7.5 billion to 72 billion cells. Their ages ranged from 25 to 74, with a median (middle) age of 58. About one-quarter were 65 or older. About 52% were male, and 48% were female. Most (95%) were White, 3% were Black, and 1% were Asian.
The study was open-label, meaning participants and researchers knew that Amtagvi treatment was given. There was no placebo or other treatment group for comparison.
What Were the Study Results?
The main goal of the study was to measure the percentage of people whose tumors shrank by a certain amount after treatment (objective response rate).
Of the 73 patients included in the main analysis, the objective response rate with Amtagvi was 31.5%. Of these patients:
- 4.1% had a complete response, meaning the cancer was no longer seen on scans.
- 27.4% had a partial response, meaning the tumors shrank but did not disappear completely.
- The median time to the first response was 1.5 months.
Your results may differ from the study results.
How Long Can the Benefits of Amtagvi Last?
Although not everyone responds to Amtagvi, some people may experience responses that last for years. It is not yet known exactly how long the benefits may last.
So far, researchers have reported longer-term results from 153 people treated with Amtagvi. After up to five years of follow-up:
- 31.4% of people responded to treatment. Of these people, 5.9% had a complete response and 25.5% had a partial response.
- Among those who responded, the response lasted a median of 36.5 months.
- Some responses improved over time — four people went from a partial response to a complete response more than one year after treatment.
- The five-year overall survival rate was 19.7%.
These results suggest that Amtagvi can lead to long-lasting responses in some people. Your results may differ from the study results. Your health care provider will make a plan with you to monitor your results over time.
Is There Any Cost Assistance Available for Amtagvi?
Amtagvi can be expensive. Financial support programs are available from Iovance, the maker of Amtagvi. Options may include a copay savings program for people with insurance coverage and patient assistance programs for those who are uninsured or underinsured. To learn more, visit this website or call 833-400-4682.
