TUESDAY, April 20, 2021 (HealthDay News) – A cutting-edge experimental drug reduces nearly half the risk of death in patients with a rare but aggressive disease cancer from ull, we clinical trial data show.
Tebentafusp has become the first drug to improve overall survival in patients with uvea melanoma, said Dr. Antoni Ribas, immediate president of the American Cancer Research Association (AACR), in a HealthDay Now Interview.
“Uveal melanoma is a disease that until now had no medical treatment,” said Ribas, director of the Tumor Immunology Program at the Jonsson Comprehensive Cancer Center and the Parker Institute for Cancer Immunotherapy Center at the University of California, Los Angeles. “Nothing had shown any improvement in the last 50 years of clinical research.”
Patients randomized to receive tebentafusp had almost half the risk of death than others treated with either. immunotherapy or chemotherapy, according to the results presented at the recent annual meeting of AACR.
Research presented at meetings is usually considered preliminary until it is published in a peer-reviewed journal.
“Tebentafusp halved the relative risk of dying and therefore had a major impact on prolonging the survival of patients with metastatic uveal melanoma,” said clinical trial researcher Dr. Jessica Hassel. She is an associate professor and head of department in the department of dermatology and at the National Center for Tumor Diseases of the University Hospital of Heidelberg, Germany. “It is therefore the first drug with a proven survival benefit for patients with uveal melanoma, and this was true even in patients where melanoma progressed.”
Uveal melanoma is rare in general, but is the most common eye cancer in adults, Hassel said. It accounts for approximately 3% to 5% of all melanomas.
The wall of the eye contains three layers. The outer layer is formed by the “white of the eye”, known as the sclera, with a clear portion at the front called the cornea through which light passes. The inner layer features a lining of nerve tissue, called the retina, that detects light and passes along optical information to the brain.
Between these two is a layer called the uvea, which is where the colored iris is located, as well as the muscles to help concentrate the eyes and blood vessels to provide oxygen and nutrition to the cells. ull.
So far, the prognosis for uveal melanoma has been very poor, with an average of people living less than a year after the cancer has spread from the eye to other parts of the body, Hassel said.
“When uveal melanoma is diagnosed, it is irradiated or operated on depending on the size of the tumor,” he said. “Half of the patients end up developing metastases, mostly in the liver, and at this time no level of care is available.”
Doctors have tried to treat cancer that has spread to the liver, in addition to using potent drugs that boost immunity, but “none of these treatments have shown an overall survival benefit,” Hassel said.
Tebentafusp is a protein that recognizes two different receptor targets, one present in melanoma cells and the other in cancer-killing T cells produced by the immune system, he said. The drug is given intravenously once a week.
“Tebentafusp builds a bridge between the tumor and the immune cells, allowing the immune cells to attack the tumor,” Hassel said. “It binds to T cells and activates them to fight ocular melanoma cells.”
This trial tested the potential of tebentafusp as a first-line therapy for eye cancer, which included 378 people with metastatic uveal melanoma. The researchers gave the experimental drug to 252 of the patients, while the rest received chemotherapy or immunotherapy.
The estimated one-year overall survival rate of patients receiving tebentafusp was 73%, compared with 59% of those receiving other therapies, the researchers reported. This represents a 49% survival benefit for the new drug.
The rate of disease control, the percentage of patients who had a complete or partial response to treatment, or the disease stabilized over an extended period of time, was 46% in patients with tebentafusp after 12 weeks. This compared to 27% of those who received chemotherapy or immunotherapy.
Side effects mainly affected the skin during the first cycles of treatment, Hassel said, and in rarer cases patients suffered an inflammatory “cytokine storm” due to overstimulation of the immune system. Only 2% of patients stopped treatment due to side effects.
According to these results, the U.S. Food and Drug Administration has granted tebentafusp the designation of advanced therapy, according to a February press release from Immunocore, the drug’s developer.
This designation is intended to accelerate the development and review of drugs for serious or life-threatening illnesses, after initial clinical evidence indicates that the drug may be substantially better than available therapies.
Researchers now intend to see if tebentafusp can be used to prevent the cancer from recurring in patients with uveal melanoma who have gone into remission, Hassel said. They also want to try the drug in combination with other drugs that boost immunity.
Immunocore funded the clinical trial.
The U.S. National Cancer Institute has more information uveal melanoma.
SOURCES: Jessica Hassel, MD, Associate Professor and Head of Section, Department of Dermatology and National Center for Tumor Disease, University Hospital of Heidelberg, Germany; Antoni Ribas, MD, PhD, director, Tumor Immunology Program, Jonsson Comprehensive Cancer Center, and director, Parker Institute for Cancer Immunotherapy Center, University of California, Los Angeles; Annual Meeting of the American Association for Cancer Research, April 9, 2021