ESMO 2023: Tebentafusp Yields Durable Long-Term Benefits for Patients With Metastatic Uveal Melanoma
ctDNA clearance occurred in 37 percent of evaluable patients treated with tebentafusp
FRIDAY, Oct. 27, 2023 (HealthDay News) -- Tebentafusp (KIMMTRAK) yields long-term benefits in overall survival among adult HLA-A*02:01-positive patients with previously untreated metastatic uveal melanoma, according to the results of a study published online Oct. 21 in the New England Journal of Medicine to coincide with the annual meeting of the European Society for Medical Oncology, held from Oct. 20 to 24 in Madrid, Spain.
In a phase 3 trial, Paul Nathan, M.D., Ph.D., from the Mount Vernon Cancer Centre, Northwood & UCLH in London, and colleagues sought to confirm the long-term survival benefit associated with tebentafusp, a T-cell receptor-bispecific molecule that targets glycoprotein 100 and CD3. Patients were randomly assigned to receive tebentafusp or the control therapy of pembrolizumab, ipilimumab, or dacarbazine. Randomization was stratified according to lactate dehydrogenase level.
The researchers found the overall response rate for tebentafusp was 11 percent compared with 5 percent for the control group. The rate of disease control (complete response, partial response, or stable disease for ≥12 weeks) was 46 percent for the tebentafusp group compared with 27 percent in the control group. At a minimum follow-up of 36 months, average overall survival in the tebentafusp group was 21.6 months versus 16.9 months in the control group (hazard ratio for death, 0.68; 95 percent confidence interval, 0.54 to 0.87). Circulating tumor DNA clearance, a predictor of overall survival, occurred in 37 percent of evaluable patients in the tebentafusp group. An estimated 27 percent of patients in the tebentafusp group were still alive at 36 months compared with 18 percent in the control group.
“These results confirm that the significant benefit conferred by tebentafusp is durable and maintained at the three-year landmark. They allow clinicians and patients to discuss the possibility of longer-term benefit with tebentafusp treatment,” Nathan told Elsevier’s PracticeUpdate, adding that the results confirm tebentafusp treatment as a “standard of care.”
Adverse events related to tebentafusp occurred early in treatment, and no new adverse events were observed with long-term administration. The most common treatment-related adverse events of any grade in the tebentafusp group were rash (83 percent), pyrexia (76 percent), pruritus (70 percent), and hypotension (38 percent). A low percentage of patients in each group discontinued treatment due to adverse events (2 percent in the tebentafusp group versus 5 percent in the control group), and no treatment-related deaths occurred.
Nathan told Elsevier’s PracticeUpdate, “Next steps will involve investigating the activity of tebentafusp in patients with residual microscopic disease following treatment of their primary tumor. An academic study, TebeMRD, is underway.”
Several authors disclosed financial ties to industry, including to Immunocore, which funded the study.
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