[Summary]
In February 2024, Debra Marsdale made a remarkable recovery from metastatic melanoma after being the first-ever patient to undergo a new FDA-approved therapy called Amtagvi (lifileucel, Iovance Biotherapeutics).
Read MoreWhat is TIL Therapy?
This innovative treatment uses TIL, or tumor-infiltrating lymphocytes, from a patient’s own tumor to amplify T cells, a type of white blood cell that plays an important role in helping the immune system function. “FDA approval of lifileucel is monumental since it represents over 30 years of research focusing on harnessing the power of T cells for oncology treatment,” Dr. Rodabe Amaria, an associate professor of melanoma, at The University of Texas MD Anderson Cancer Center told SurivorNet.“The process of treating a patient with TIL is highly complicated with a number of distinct components. An essential component to commercialization of TIL is in perfecting the methodology to grow good quality T cells in a short period of time in a way that maintains the highest standard of patient safety and lifileucel is the first cellular therapy in solid tumors to meet and exceed these standards,” he adds.
How the one-time, personalized treatment works:
- Doctors extract TILs from a sample of the patient’s own tumor.
- They multiply the cells in the lab to grow billions of them
- Then, they inject all of the lab-made cells into the patient, effectively creating an army of cancer-fighting cells.
Before putting the cells back, the patient undergoes multiple rounds of chemotherapy. This is to make space in their immune system for the new, powerful cells.
After that, the patient receives a drug called interleukin-2, which helps these cells grow stronger and more active in the body.
Despite the grueling 16-day infusion process, Marsdale said she found the ordeal worthwhile, commenting that it was like winning a “lottery ticket to life.”
How TILs Work
TILs are already programmed naturally to fight cancer. When the treatment increases their numbers, it gives them a boost and they become a much stronger force against cancer. They help to shrink tumors and, in some cases, eliminate them entirely.
Amtagvi is a significant advancement in treating metastatic melanoma for patients who have exhausted other options.
Metastatic melanoma is a very serious type of skin cancer that has spread from where it first appeared to other parts of the body.
Melanoma is often caused by exposure to ultraviolet light, which can come from sunlight or indoor tanning. Although melanomas only represent about 1% of all skin cancers, they account for a significant number of cancer-related deaths.
Amtagvi’s approval is a first for a cellular therapy used to treat solid tumors. It shows promise beyond melanoma to potentially address 90% of all cancer types.
“Melanoma is the gateway tumor and once a new immunotherapy has proven efficacy in melanoma, there is great interest in expanding reach into other solid tumors and thus expanding the reach of this type of treatment,” Dr. Amaria says.
Watch: Dr. Cecelia Larocca on Immunotherapy for Melanoma
The Evidence
Amtagvi has been given what the FDA refers to as “accelerated approval”. This means it’s cleared for use, but the agency wants more information to fully confirm its benefits and safety before granting it full approval.
The current approval was given based on the results of a Phase 2 clinical trial that found patients with advanced melanoma who were given Amtagvi had real and lasting benefits.
Overall response to the drug was extremely positive. Of the 73 patients who participated in the trial:
- 31.5% had some response to the drug
- 3 patients saw their tumors disappear entirely
- 20 patients had at least some beneficial response
- At six, nine, and twelve months, a significant percentage of patients had no tumor progression or didn’t die.
A larger Phase 3 trial is currently underway to confirm Amtagvi’s success in treating metastatic melanoma. If the trial has good results, it should lead to the drug’s full FDA approval.
As Dr. Amaria notes, TIL therapy is being looked at for treating other cancers as well. One TIL trial looking at non-small cell lung cancer was stopped after a participant died. The company said the death might have been caused by chemotherapy or interleukin 2 rather than the TIL.
“The current Phase III doesn’t include any major tweaking of manufacturing to improve outcomes. However, there are a number of ongoing clinical trials looking to genetically manipulate TIL to hopefully make them more effective and to improve on safety,” Dr. Amaria notes.
The Amtagvi trial was conducted at MD Anderson Cancer Center at Cooper University Health Care, but Dr. Amaria was not one of the investigators.
Related: The Future of Biomarkers in Melanoma Treatment
Are there any downsides to Amtagvi?
Amtagvi was found safe, although the full treatment regimen did carry side effects including:
- Nausea
- Fatigue
- Risk of other illnesses because chemotherapy made them weaker.
Side effects specific to Amtagvi Include:
- Rapid heart rate
- Fluid buildup in the body
- Rash
- Hair loss
- Feeling short of breath
Side effects were generally considered manageable, especially considering the drug’s potential benefit for treating an otherwise deadly cancer.
At $515,000, cost is another important aspect of Amtagvi treatment to consider.
Some insurance companies will cover all or part of the cost. It’s very important to discuss the expense of this drug with your care team to make sure you understand all of your options.
Who is a candidate for Amtagvi
Patients most likely to benefit from Amtagvi include:
- People with metastatic melanoma
- Patients who have tried other treatments like surgery, chemotherapy, or radiation, but these have not worked.
- Individuals who have previously been treated with specific therapies targeting the PD-1 protein
- People who have been unsuccessfully treated with special drugs to target a change, or mutation, in a gene called BRAF, specifically at a point known as V600. that makes the cancer grow faster.
Marsdale’s successful treatment not only offered her a new lease on life but also brought hope that this therapy could prevent other families from enduring the pain of cancer loss.
Now, with the therapy’s FDA approval, it stands as a potential first-line treatment for melanoma patients, promising a significant shift in managing this deadly disease. It has the potential to extend lives and offer hope for patients in a broad range of cancers where traditional treatments fall short.
Related: Why I’d Choose a Clinical Trial For Myself
Questions for your doctor
- Am I a good candidate for Amtagvi?
- What will the full treatment be like for me?
- What side effects can I expect and how will we manage them?
- Will insurance cover the costs or are there financial aid or grants available?
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