TIL therapy — a first of its kind — offers new hope for patients with metastatic melanoma

Image of T cell attacking melanoma cell

Roswell Park is the only authorized treatment center in the region for the new breakthrough cellular therapy, Amtagvi

Imagine if your body, using its own immune cells as medicine — killer white blood cells known as T lymphocytes or T cells — could fight your cancer. That’s the idea behind a new type of cellular therapy called tumor-infiltrating lymphocyte (TIL) therapy — and it’s working. This month, the U.S. Food & Drug Administration (FDA) approved the very first TIL therapy, Amtagvi, also known as lifileucel, for use in patients with metastatic melanoma whose disease has not responded to other therapies.

“Amtagvi offers an important option for the 10 to 20% of patients with advanced melanoma that has proven quite challenging,” says medical oncologist Igor Puzanov, MD, MSCI, FACP, Chief of Melanoma and Director of the Center for Early Phase Clinical Trials at Roswell Park Comprehensive Cancer Center. “Their disease is metastatic, cannot be treated with surgery and has progressed despite immunotherapy with immune checkpoint inhibitors or targeted therapy. We’re thrilled that Roswell Park can offer Amtagvi to these patients.”

One of the pivotal clinical trials that paved the way to FDA approval was conducted at Roswell Park and led by Dr. Puzanov, offering Roswell Park patients early access to the treatment. This multi-site trial at cancer centers around the world found that Amtagvi could attack patients’ melanoma cells, reduce the size of tumors and produce a lasting response. More than a third — 36% of patients — responded to the treatment, including nearly 6% who saw a complete response, and many continued responding more than two years later. 

What is TIL therapy? 

A form of adoptive cellular therapy — where the patient’s own cells are used as a living drug — TIL therapy is the first cell therapy for solid tumor cancers, which account for about 80% of all cancer cases. Other cellular therapies such as stem cell or bone marrow transplant and chimeric antigen receptor (CAR) T-cell therapy, are predominantly for blood cancers such as lymphoma, leukemia and multiple myeloma. Finding ways to make cellular therapy effective in solid tumor cancers is a primary focus of research at Roswell Park.

TIL therapy uses the T cells that are found within the patient’s own tumor. Because these T cells have already infiltrated the tumor, they know how to find the cancer cells, but they are suppressed in their tumor-killing abilities or there are simply not enough of them to eradicate the cancer. TIL therapy takes T cells from the patient’s tumor, activates and multiplies them into billions in a lab, and returns the T cells to the patient. 

Another type of adoptive cellular therapy that emerged in recent years, CAR T-cell therapy, uses a similar process, except that the T cells are extracted from the patients’ blood and must be genetically altered to recognize a specific antigen (or protein) on the cancer cell. “The beauty of TIL therapy is that the T cells need no engineering. They simply must be multiplied and activated,” says Dr. Puzanov.

Latest breakthrough may treat many cancer types 

Amtagvi is currently approved for only this smaller group of melanoma patients: those with unresectable or metastatic melanoma whose disease has progressed on or after anti-PD-1 or PD-L1 therapy and targeted BRAF/MEK inhibitor therapy. However, Dr. Puzanov sees use of Amtagvi expanding to patients with other challenging diagnoses: “The first type of cancer that showed a response to TIL therapy is melanoma,” says Dr. Puzanov. “But other cancers are close behind.” Clinical trials of Amtagvi in patients with cervical cancer and non-small cell lung cancer are ongoing at Roswell Park, and another for young adult patients with sarcoma is expected to open soon.

Immunotherapy at Roswell Park

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Roswell Park leads the way

Cutting-edge cellular therapies require a sophisticated multispecialty team of surgeons and oncologists, with unique experience in oncology, immunotherapy, cellular therapy and toxicity management to deliver safely. Roswell Park is a leader in these revolutionary treatments, dedicating clinical expertise, research and infrastructure — and establishing New York State’s first Cell and Gene Therapy hub to speed their development.

Dr. Puzanov is member of the TIL Therapy Working Group, an international assembly of TIL therapy experts providing guidance on managing toxicities and best patient selection and practices. Roswell Park is a leader in these revolutionary treatments. Our team includes physician-scientists who were among the early researchers and inventors of the technologies that make these cellular therapies possible and opened the first CAR T-cell clinical trial 17 years ago.

“When you come to Roswell Park, you’re going to be treated by clinicians who have long and deep experience in them,” says Marco Davila, MD, PhD, Senior Vice President and Associate Director for Translational Research, and one of the early pioneers of T-cell therapy. “We use that experience to continually push for improvements in how we deliver them to patients. How can we make them safer, more efficacious?”