Real-life data on tebentafusp in metastatic uveal melanoma patients from four EURACAN expert centres

Abstract

Background: Tebentafusp is the first approved systemic therapy with overall survival (OS) benefit in HLA-A*02:01-positive patients with metastatic uveal melanoma (mUM). We present the largest real-life study on safety and efficacy. Methods: Retrospective multicenter study, patients started tebentafusp Early Access between May 2021 and May 2023 in 4 EURACAN centres (European Reference Network for Rare Adult Solid Cancers); Institut Curie Paris, Leiden University Medical Center, Maria Sk & lstrok;odowska-Curie National Research Institute of Oncology, and Cliniques universitaires Saint-Luc UCLouvain Bruxelles. Results: 175 patients were included: 127 received first-line tebentafusp, 48 had prior immune checkpoint inhibitors and/or chemotherapy. Median age was 64 (range 23-87), 75 patients (43 %) had an ECOG performance-status score of 0, and 103 patients (59 %) had a normal lactate dehydrogenase (LDH). Thirty-two patients (18 %) developed transient grade 3-4 toxicity, mostly rash, 5 patients had grade 3 cytokine release syndrome. According to RECIST 1.1, 1 patient had complete response (CR), 7 patients (4 %) partial response (PR), 82 patients (47 %) stable disease (SD) as best response. 76 patients (43 %) were treated beyond progression; 1 was the CR, 1 PR and 30 SD. Median progression-free survival (PFS) was 4 months (95 % CI 2.7-5.3), median OS was 20 months (95 % CI 15.3-24.6). 1-year OS rate was 63.6 %. Survival was significantly lower for patients with elevated LDH or extrahepatic metastases. Conclusion: Tebentafusp is safe for pre-treated and treatment-naive patients with mUM in real-life. Treatment effect was observed in patients treated beyond initial progression. Patients with baseline elevated LDH and extrahepatic metastases had significantly shorter survival.