Lifileucel (AMTAGVI)

AMTAGVI, also known by the generic name lifileucel, is a type of cellular therapy that uses Tumor Infiltrating Lymphocytes (TILs) to treat patients with advanced melanoma whose melanoma hasn’t responded – or quit responding – to PD-1 based immunotherapies and BRAF/MEK targeted therapy if their melanoma has the BRAF mutation.

TIL therapies, like AMTAGVI, aim to harness the patient's own immune system to target and destroy cancer cells. 

What is AMTAGVI?

AMTAGVI is a Tumor-Infiltrating Lymphocyte (TIL) therapy used in the treatment of advanced melanoma. TIL Therapies involve extracting immune cells called lymphocytes from a patient's tumor, growing them in a laboratory, and then reinfusing them back into the patient's body. TIL therapies aim to harness the patient's own immune system to target and destroy melanoma cells. The infused TILs have been specifically selected and expanded to recognize and attack tumor cells. 

How Does AMTAGVI Work?

AMTAGVI works to enhance the body's natural immune response against melanoma cells. The lymphocytes that are extracted from the tumor are typically the ones that have already recognized and targeted the melanoma cells. By expanding and reinfusing these lymphocytes, it is hoped that they will be able to better recognize and attack the cancer cells throughout the body. 

Which Patients May Benefit from AMTAGVI?

The U.S. Food and Drug Administration (FDA) approved the use of AMTAGVI to treat adult patients 18 years of age or older who have unresectable or metastatic melanoma (those with Stage 3 or Stage 4 melanoma).

AMTAGVI is approved in the second-line setting. This means, that to be eligible for AMTAGVI, patients must have progressed while being treated with PD-1 based immunotherapy and BRAF/MEK targeted therapy if their melanoma is BRAF mutant. 

Due to the complex nature of TIL therapy, not all patients are healthy enough to receive it. Talk to your doctor to see if you are a good candidate.

How is AMTAGVI Given?

Patients will be admitted into the hospital prior to receiving AMTAGVI. This is done so that doctors can carefully monitor you for any adverse events that may result from the chemotherapy used to pre-condition your body before the TIL infusion or the interleukin-2 given after. AMTAGVI is offered only at Authorized Treatment Centers.

Here's how AMTAGVI is given: 

  1. Tumor Tissue Collection: The first step is the surgical removal of a tumor from the patient. This tumor tissue contains immune cells called lymphocytes, including T cells, that have infiltrated the tumor. 
  2. Manufacturing: The tumor tissue is then shipped to a specialized laboratory where the T cells (called a lymphocyte) are isolated from the tumor. These T cells are then grown and expanded a billion-fold. The personalized therapy is then frozen and sent back to the treating hospital. The manufacturing process can take up to three weeks.
  3. Conditioning: Before the T cells can be infused back into the patient, the patient will undergo a conditioning regimen of chemotherapy. This conditioning helps to suppress the patient’s immune system and create space for the infused T cells to expand and function effectively. 
  4. Infusion: The activated and expanded T cells are then infused back into the patient's bloodstream. These T cells can then travel to the tumor site and target melanoma cells.
  5. Post Infusion: Three to 24 hours after receiving the T cells, patients will receive interleukin-2 (aldesleukin) to stimulate T cell activity.

Once the T cells are infused, they can migrate to the tumor site and infiltrate tumor tissue. These activated T cells were selected because they are able to identify unique characteristics found on the surface of melanoma cells and then initiate an immune response against them. The T cells can directly kill the cancer cells and can help attract other immune cells to the tumor site. 

It's important to note that TIL therapy is a complex and personalized treatment approach. The success of TIL therapy depends on various factors, including the quality and quantity of the isolated TILs, the conditioning regimen, and the characteristics of the patient's tumor. 

If you or someone you know is considering TIL therapy for melanoma, it is crucial to consult with a qualified healthcare professional who can provide personalized advice and guidance based on the individual's specific medical condition and circumstances.

What Are the Goals of AMTAGVI Therapy?

AMTAGVI works to promote an immune response, with the goals of:

  • Controlling melanoma and shrinking tumors anywhere in the body
  • Treating symptoms of melanoma
  • Helping patients live longer

The FDA approval for AMTAGVI is based on results from the Phase 2 C-144-01 trial. In the study, 73 patients with advanced melanoma who were  previously treated with anti-PD-1 therapy and targeted therapy, where applicable, received AMTAGVI. For these patients, the average time to response was 1.5 months, the objective response rate (a measurement of complete or partial tumor shrinkage)  was 31.5%, with the median duration of response not yet achieved.

What Should I Ask My Doctor About AMTAGVI?

Not all treatments work for all patients with melanoma, because everyone is different. If you are interested in learning more about AMTAGVI, here are some questions you should ask your doctor:

  • Am I eligible for AMTAGVI?
  • What is your experience with AMTAGVI?
  • Were you involved with the AMTAGVI clinical trials?
  • Is this a good option for my melanoma treatment?
  • How successful has AMTAGVI been for patients like me?
  • How long will I be hospitalized?
  • Where is the nearest Authorized Treatment Center?
  • What are the side effects of AMTAGVI?
  • What side effects will I experience after I am discharged from the hospital?
  • Are there any clinical trials that I should consider?
  • What other treatments are FDA-approved for treating advanced melanoma?
  • What are the risks and benefits of the available treatment options?
  • What are the goals for my treatment?
  • How long will I stay on this treatment?

Need Help Paying for AMTAGVI?

Patient Assistant Programs (PAPs) are designed so that you still have access to the treatments you need, in any financial circumstance. Learn more about the manufacturer’s patient assistance program and other options here.

Manufacturer’s Patient Assistance