FDA Approves Amtagvi, a Novel TIL Therapy, for Advanced Melanoma
Key Insights
The FDA has approved Amtagvi (lifileucel), the first tumor-infiltrating lymphocyte (TIL) therapy, for metastatic melanoma (search) patients who have progressed after other therapies.
Clinical trials showed that Amtagvi led to a response rate of 36% in patients, with nearly 6% achieving a complete response, and many continuing to respond for over two years.
TIL therapy involves using a patient's own T cells to target cancer, offering a personalized approach without the need for genetic engineering, unlike CAR T-cell therapy.
The U.S. Food and Drug Administration (FDA) has approved Amtagvi (lifileucel), marking the first tumor-infiltrating lymphocyte (TIL) therapy for patients with metastatic melanoma (search) whose disease has progressed despite prior treatments. This approval offers a new hope for the 10-20% of advanced melanoma patients who have not responded to other therapies.
Clinical Trial Success
Pivotal clinical trials, including one conducted at Roswell Park Comprehensive Cancer Center, demonstrated Amtagvi's ability to target melanoma (search) cells, reduce tumor size, and produce lasting responses. The multi-site trial revealed that 36% of patients responded to the treatment, with nearly 6% experiencing a complete response. Many patients continued to show a response for more than two years.
How TIL Therapy Works
TIL therapy is a form of adoptive cellular therapy that uses a patient's own immune cells as a living drug. T cells found within the patient's tumor are extracted, activated, and multiplied in a lab before being reintroduced to the patient. These T cells, already familiar with the tumor, can effectively target cancer cells without the need for genetic engineering, setting it apart from CAR T-cell therapy.
Expanding Applications
While Amtagvi is currently approved for melanoma (search) patients who have progressed on or after anti-PD-1 (search) or PD-L1 (search) therapy and targeted BRAF (search)/MEK (search) inhibitor therapy, research is underway to explore its use in other cancers. Clinical trials are ongoing for cervical cancer (search) and non-small cell lung cancer (search), with plans to open a trial for young adult patients with sarcoma (search). "The first type of cancer that showed a response to TIL therapy is melanoma," says Dr. Igor Puzanov, MD, MSCI, FACP, Chief of Melanoma and Director of the Center for Early Phase Clinical Trials at Roswell Park Comprehensive Cancer Center. "But other cancers are close behind."
Roswell Park's Leadership
Roswell Park Comprehensive Cancer Center is at the forefront of cellular therapy research and treatment. The center's expertise in oncology, immunotherapy, and cellular therapy, combined with its dedicated infrastructure, positions it as a leader in advancing these innovative treatments. Dr. Puzanov is a 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.