Northside Hospital is the first hospital in Georgia, one of just 27 nationwide, authorized to deliver a new treatment option for patients with unresectable or metastatic melanoma and who have exhausted traditional therapies.
AMTAGVI™ — made by Iovance Biotherapeutics — is the first and only T-cell therapy approved by the Food and Drug Administration (FDA) for solid tumor cancer. Its approval on Feb. 16 also marks the first treatment option for unresectable or metastatic melanoma previously treated with anti-PD-1 and other targeted therapy.
Why this matters: Metastatic melanoma, notoriously aggressive, is traditionally treated with a combination of therapies, including surgery, radiation, chemotherapy, immunotherapy, limb infusion and perfusion. In many cases, unfortunately, the tumor proves resistant and patients have very poor outcomes.
The American Cancer Society estimates nearly 3,500 new cases of melanoma in Georgia in 2024; 190 people will die from the disease.
The FDA approval of AMTAGVI presents a ray of hope for those battling this challenging disease.
What they’re saying: “Over the past decade, immunotherapy and targeted agents have allowed patients with metastatic melanoma to achieve a significant improvement in overall survival; unfortunately, close to 50% of these patients eventually become refractory to these therapies,” said Dr. Nicole Kounalakis, medical director of the Northside Hospital Cancer Institute Melanoma & Skin Cancer Program. “We are excited to be the first cancer center in Georgia to offer this novel therapy.”
Added Dr. Melhem Solh, medical director of Northside’s cellular therapy program, “Tumor-infiltrating lymphocyte (TIL) therapy is a very promising treatment for patients with melanoma who failed immunotherapy or targeted therapy. The pivotal trials that led to the approval showed this therapy can lead to durable responses among patients who failed currently available immunotherapies. This is very exciting news for melanoma patients and adds a very effective treatment to fight their cancer.”
How it works: TIL cells recognize distinctive tumor markers on the cell surface of each person’s cancer. When cancer develops and prevails, the body’s natural TIL cells can no longer perform their intended function to fight cancer.
During a one-time TIL cell therapy treatment, a part of the tumor is removed from the body. The immune (TIL) cells are isolated in a lab and grown to large numbers. Once the cells are ready, they are given back to the patient to locate, attack and destroy the cancer.
Update May 30: As of April 4, 2024, AMTAGVI (lifileucel) has received NCCN’s Category 2A designation in the NCCN Melanoma Guidelines (v2.2024) as a second line or subsequent, preferred therapy for metastatic or unresectable disease. AMTAGVI remains the only recommendation with an FDA-approved indication for patients previously-treated with PD-1 therapy.
Eligibility:
- >18 years of age with unresectable or metastatic melanoma
- Must have progressed on at least 1 previous systemic therapy, including a PD-L1 antibody, and if they had BRAF V600E mutation–positive disease, a BRAF or BRAF/MEK inhibitor
- At least 1 resectable lesion
Next steps: To make an AMTAGVI TIL referral, or to speak with a physician, please call 404-255-1930.
Read more about the Melanoma Program at Northside.
Read more about Northside Hospital Cancer Institute’s Immunotherapy Program.
