By Dennis Thompson
HealthDay reporter
TUESDAY, April 20, 2021 (HealthDay News) – An innovative experimental drug cuts nearly half the risk of death in patients with a rare but aggressive eye cancer, new data from clinical trials show.
Tebentafusp is now the first drug shown to improve overall survival for patients with uveal melanoma, said Dr. Antoni Ribas, past president of the American Association of Cancer Research (AACR), in a HealthDay Now interview.
“Uveal melanoma is a disease that has not received 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 at Los Angeles. “Nothing has improved in the last 50 years of clinical research.”
Patients randomly selected to receive tebentafusp had almost half the risk of death as others treated with either immunotherapy or chemotherapy. This is evident from the results presented at the recent AACR annual meeting.
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Research presented at meetings is generally considered preliminary until published in a peer-reviewed journal.
“Tebentafusp halved the relative risk of death 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 at Heidelberg University Hospital in Germany. “This makes it the first drug with a proven survival benefit for patients with uveal melanoma, and this was even true for patients who progressed with melanoma.”
Uveal melanoma is rare overall, but the most common eye cancer in adults, Hassel said. It makes up about 3% to 5% of all melanomas.
The wall of the eye contains three layers. The outer layer is made up of the “white of the eye” known as the sclera, with a clear part on the front called the cornea that light passes through. The inner layer consists of a lining of nerve tissue called the retina, which perceives light and transmits optical information to the brain.
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In between is a layer called the uvea, which is home to the colored iris, as well as the muscles that help your eye focus and blood vessels supply the eye cells with oxygen and nutrients.
So far, the prognosis for uveal melanoma has been very poor. People lived, on average, less than a year after the cancer spread from the eye to other parts of the body, Hassel said.
“When uveal melanoma is diagnosed, it is broadcast or operated on, depending on the size of the tumor,” she said. “Half of the patients eventually develop metastasis, mostly to the liver, and at this point there is no standard of care.”
Doctors have tried treating the cancer that has spread to the liver and using strong immune-boosting drugs, but “none of these treatments have shown an overall survival benefit,” Hassel said.
Tebentafusp is a protein that recognizes two different receptor targets, one on melanoma cells and the other on cancer-killing T cells made by the immune system, she said. The drug is given intravenously once a week.
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“Tebentafusp builds a bridge between the tumor and the immune cells and enables the immune cells to attack the tumor,” said Hassel. “It binds T cells and activates them to fight the melanoma cells in the eye.”
This study tested the potential of tebentafusp as a front-line therapy for eye cancer, which enrolled 378 people with metastatic uveal melanoma. The researchers gave 252 of the patients the experimental drug while the rest received either chemotherapy or immunotherapy.
The estimated one-year overall survival rate for patients receiving tebentafusp was 73%, compared with 59% for patients receiving other therapies, the researchers reported. This corresponds to a survival advantage of 49% for the new drug.
The disease control rate – the percentage of patients who fully or partially responded to their treatment, or whose disease stabilized over time – was 46% in Tebentafusp patients after 12 weeks. This compared with 27% for those who received chemotherapy or immunotherapy.
Side effects mostly affected the skin in the first few courses of treatment, Hassel said, and more rarely, patients experienced an inflammatory “cytokine storm” from overstimulation of the immune system. Only 2% of patients stopped treatment because of side effects.
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Based on these results, the US Food and Drug Administration awarded Tebentafusp a breakthrough therapy award in February, according to a press release from Immunocore, the developer of the drug.
This designation is intended to expedite drug development and review for serious or life-threatening diseases after early clinical evidence showed that the drug may outperform the therapies available.
Researchers now want to see if tebentafusp can be used to prevent cancer from recurring in uveal melanoma patients who have gone into remission, Hassel said. You also want to test the drug in combination with other immune-boosting drugs.
Immunocore funded the clinical trial.
More information
The US National Cancer Institute did more about uveal melanoma.
SOURCES: Dr. med. Jessica Hassel, Associate Professor and Head of Department, Department of Dermatology and National Center for Tumor Diseases, Heidelberg University Hospital; Antoni Ribas, MD, PhD, director of the Jonsson Comprehensive Cancer Center’s tumor immunology program and director of the Parker Institute for Cancer Immunotherapy, University of California, Los Angeles; American Association for Cancer Research Annual Meeting April 9, 2021
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