FDA approves first T cell therapy for melanoma
CANCER DIGEST – Feb. 16, 2024 – The FDA today has approved a new T-cell therapy for the treatment of melanoma. The therapy called AMTAGVI™ is the first such therapy approved for a solid tumor cancer.
The approval is specific for patients who have melanoma that cannot be treated with surgery, or has spread to other parts of the body and have had previous treatment with a PD-1 inhibitors, such as Keytruda, Opdivo or Libtayo. In short, the approval for AMTAGVI is for patients who have run out of options.
“The approval of AMTAGVI™ offers hope to those with advanced melanoma who have progressed following initial standard of care therapies, as the current treatment options are not effective for many patients,” Samantha Guild, J.D., President of the AIM at Melanoma Foundation said in a press release. “This one-time cell therapy represents a promising innovation for the melanoma community, and we are excited by its potential to transform care for patients who are in dire need of additional therapeutic options.”
According to Iovance Biotherapeutics, which makes the drug, AMTAGVI is the first and only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer. Other T cell therapies have been approved for leukemias, lymphomas and other cancers of the blood, but have not been as effective against solid tumors.
The treatment uses patient-specific T cells called TIL or tumor-infiltrating lymphocytes, a specialized type of white blood cell in the immune system. These are immune cells that recognized the tumor and attacked it, but there weren’t enough of them to destroy it.
For the AMTAGVI therapy doctors remove these TIL cells from inside the tumor, and grow them in large numbers and infuse them back into the patient, where the hope is that now armed with reinforcements the immune system will destroy the cancer.
According to the FDA press release, the approval of AMTAGVI was through the accelerated approval pathway, meaning it is for life-threatening illnesses where there is an unmet medical need. The safety and effectiveness of AMTAGVI was tested in a global, multi-center clinical trial involving patients with multiple types of solid tumor cancers including those with metastatic melanoma previously treated with PD-1 blocking antibodies.
Among the 73 melanoma patients treated with AMTAGVI at the recommended dose, 31.5 percent showed an objective response, meaning the tumor stopped growing or began to shrink. Of those patients whose achieved an objective response, three patients achieved a complete response, or no signs of cancer detected following treatment.
Among the other patients who responded, 56.5 percent had a continued response six months after treatment, 47.8 percent continued to respond nine months after treatment and 43.5 percent maintained a response a year after treatment.
The most common adverse side effects included chills, fever, fatigue, abnormally fast heart rate (tachycardia), diarrhea, low levels of certain white blood cells (neutropenia), hair loss, infections, low blood oxygen levels and shortness of breath.
Interim Iovance CEO Frederick Vogt told Reuters he expects the one-time treatment to list at $515,000. The possibility for the approach in other solid tumors, however, makes the potential market for the therapy very large.
Sources: FDA press release, Iovance Pharmaceutical press release, Memorial Sloan Kettering Cancer Center news.
