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The first patient was enrolled in a phase 3 trial for patients with non-metastatic uveal melanoma to either receive Kimmtrak or observation.
The phase 3 ATOM study will evaluate the use of Kimmtrak compared with observation in patients with non-metastatic uveal melanoma.
The first patient was enrolled in a phase 3 trial and was randomly assigned to receive treatment for non-metastatic uveal melanoma.
This type of melanoma forms in the uvea of the eye, or the area of the eye that makes the dark-colored pigment, according to the National Cancer Institute. Uveal melanoma is considered rare and is the most common type of eye cancer among adults.
Patients in the phase 3 ATOM trial will be randomly assigned to two groups: no treatment for observation or Kimmtrak (tebentafusp). The main goal is to evaluate the effectiveness of Kimmtrak in preventing or delaying relapse in patients with primary uveal melanoma at high risk of relapse, compared with observation.
Overall survival: the time patients live, regardless of their disease status, until death by any cause.
ECOG performance status: a score that measures patients’ ability to complete everyday tasks independently. A status of 0 means they can perform all daily tasks independently, while a status of 4 means they cannot perform daily tasks independently.
Cytokine release syndrome: when the immune system overreacts to an immunotherapy drug or an infection, which can become life-threatening.
Kimmtrak is a type of drug that binds to certain antigens on the surface of uveal melanoma cells. This helps the immune system destroy cancer cells, as defined by the National Cancer Institute.
“I am delighted that the first patient on ATOM has been recruited. This milestone reflects a very significant effort by the European Organisation for Research and Treatment of Cancer melanoma group trials team, colleagues at Immunocore and our trial sites,” Dr. Paul Nathan, consultant medical oncologist and ATOM study coordinator, said in a news release from Immunocore, the manufacturer of Kimmtrak. “The study addresses a key question — whether the benefit seen with [Kimmtrak] in HLA-A*02:01-positive patients with metastatic uveal melanoma will translate to a significant reduction in risk of relapse for patients who have received treatment for primary uveal melanoma and are at high risk of relapse.”
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The study’s researchers are expected to enroll 290 patients with uveal melanoma who have previously received definitive treatment by surgery or radiation therapy, according to the release. Patients eligible for the study also have HLA-A*02:01-positive disease, adequate organ function and an ECOG performance status of 0 or 1.
Secondary goals within the study include overall survival, safety and tolerability. Additional goals researchers will evaluate are circulating tumor DNA to identify remaining cancer in the body and a comparison of health-related quality of life between the two treatment groups.
“Despite definitive local therapy, approximately 50% of patients will eventually relapse with metastatic disease. The goal of investigating adjuvant [Kimmtrak] following primary treatment is to prevent future recurrence,” Mohammad Dar, chief medical officer at Immunocore, said in the release. “Decreasing the likelihood of a patient relapsing following definitive therapy for their primary disease would be a groundbreaking advancement in treatment, given there are currently no standard treatment options available in this setting.”
Kimmtrak was previously approved by the Food and Drug Administration in early 2022 for patients with unresectable (surgically unremovable) or metastatic uveal melanoma. The approval was based on findings from the phase 3 IMCgp100-202 trial, which included patients with metastatic uveal melanoma who were not previously treated. Patients in this study were randomly assigned to either receive treatment of Kimmtrak or investigator’s choice, including Yervoy (ipilimumab), Keytruda (pembrolizumab) or dacarbazine.
Side effects associated with Kimmtrak, based on the IMCgp100-202 trial, included fever in 4% of patients, rash in 18% and itching in 5%. Of note, cytokine release syndrome was reported in less than 1% of patients and was well managed.
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