Tebentafusp in Patients with Metastatic Uveal Melanoma: A Real-Life Retrospective Multicenter Study

Abstract

Background: Tebentafusp has recently been approved for the treatment of metastatic uveal melanoma (mUM) after proving to have survival benefits in a first-line setting. Patients and Methods: This retrospective, multicenter study analyzed the outcomes and safety of tebentafusp therapy in 78 patients with mUM. Results: Patients treated with tebentafusp had a median PFS of 3 months (95% CI 2.7 to 3.3) and a median OS of 22 months (95% CI 10.6 to 33.4). In contrast to a published Phase 3 study, our cohort had a higher rate of patients with elevated LDH (65.4% vs. 35.7%) and included patients with prior systemic and local ablative therapies. In patients treated with tebentafusp following ICI, there was a trend for a longer median OS (28 months, 95% CI 26.9 to 29.1) compared to the inverse treatment sequence (24 months, 95% CI 13.0 to 35.0, p = 0.257). The most common treatment-related adverse events were cytokine release syndrome in 71.2% and skin toxicity in 53.8% of patients. Tumor lysis syndrome occurred in one patient. Conclusions: Data from this real-life cohort showed a median PFS/OS similar to published Phase 3 trial data. Treatment with ICI followed by tebentafusp may result in longer PFS/OS compared to the inverse treatment sequence.

Efficacy and safety of tebentafusp in patients with metastatic uveal melanoma: A systematic review and meta-analysis

“…Figure 1 shows the PRISMA flow chart of the meta-analysis. These studies included four clinical trials, 14–17 one retrospective cohort study, 18 and one case-series study, 19 all of which were published in full text. Five studies explored the efficacy and safety of tebentafusp, while one study investigated only the safety of tebentafusp.…”

Sepsis‐like cytokine release syndrome after application of tebentafusp in metastasized uveal melanoma

“…It was approved for HLA-A*02:01-positive unresectable, metastatic uveal melanoma (mUM) by the European Medicines Agency in April 2022. 1,2 Cytokine release syndrome (CRS) is a common treatment-related adverse event observed in T-cell-engaging immunotherapeutic drugs, such as tebe. 3 Fortunately, most tebe-related CRS are mild-to-moderate in severity and reversible with standard management strategies.…”

“…Glenn Geidel 1,2 Finn Abeck 1 Inga Hansen 1 Julian Kött 1,2 Isabel Heidrich 1,2 Alessandra Rünger 1,2 Lina Hildebrandt 1 Christoffer Gebhardt…”