Real-life data on tebentafusp in metastatic uveal melanoma patients from four EURACAN Expert Centres
Menée à partir de données portant sur 175 patients atteints d'un mélanome de l'uvée de stade métastatique (âge médian : 64 ans), cette étude rétrospective multicentrique évalue la toxicité et l'efficacité, du point de vue de la survie sans progression et de la survie globale, du tébentafusp
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
łodowska-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.
European Journal of Cancer , résumé, 2025