Patients with melanoma may soon be able to access a new immunotherapy that was recently approved by the U.S. Food and Drug Administration (FDA). The cell-based treatment, which was developed by Iovance Therapeutics, will first be administered by physicians at the Siteman Cancer Center in Washington University before it can be commercialized under the name Amtagvi.
The tumor-infiltrating lymphocyte immunotherapy has been designed for the treatment of metastatic melanoma, which is a skin cancer that has spread to other parts of the body. The treatment, called lifileucel, has been designed specifically for patients suffering from this particular cancer whose tumor is continuously growing and spreading despite treatment from other standard therapies including immune checkpoint inhibitors and chemotherapy as well as surgery.
Scientists and doctors at Washington University were part of the clinical trials that led to the treatment’s approval under accelerated approval regulations. These regulations allow the FDA to approve therapies for severe conditions and illnesses with unmet medical needs. In order to be approved, these treatments have to demonstrate clinical benefit to patients, either by extending survival of patients or improving how patients function or feel.
The regulations also afford patients the opportunity to access promising treatments while additional trials are still being carried out to ascertain the treatment’s clinical benefits.
This new treatment’s mechanism of action involves the use of a patient’s T cells to try to kill the cancer. Using a patient’s T cells eliminates the risk of immune cells attacking healthy tissues, which sometimes occurs during stem cell transplantation for blood cancers.
The cutaneous oncology program, under the division of oncology at Washington University, will administer the new therapy for melanoma patients who meet the eligibility criteria. To tailor the immunotherapy for each patient, physicians at an authorized treatment facility will obtain a sample of the tumor and send the tissue to Iovance’s manufacturing facility, where lymphocytes that will infiltrate the tumors will be isolated and expanded. The treatment will then be cryopreserved and shipped. The treatment will then be introduced into a patient’s body through an intravenous infusion, which will increase its effectiveness in the elimination of tumor cells in the body.
Findings from trials on the immunotherapy determined that tumors reduced in size by roughly 30% in about one-third of patients following the treatment’s introduction to the body. About a year after the treatment’s single administration, almost half of the patients included in the trial whose tumors responded to the treatment were in remission.
The trial’s findings were published in the “Journal for ImmunoTherapy of Cancer.”
Immunotherapies are likely to play an increasing role in the fight against different cancers. The existence of many entities such as Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) offers hope that more immunotherapies could hit the market in the not-too-distant future.
NOTE TO INVESTORS: The latest news and updates relating to Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) are available in the company’s newsroom at https://ibn.fm/SCNI
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