Final 5-Year Follow-Up Results Evaluating Neoadjuvant Talimogene Laherparepvec Plus Surgery in Advanced Melanoma: A Randomized Clinical Trial
Cette étude analyse les résulats à 5 ans d'un essai évaluant l'intérêt, du point de vue de la survie sans récidive, d'ajouter le talimogène laherparépvec (un vaccin oncolytique) à une chirurgie chez des patients atteints d'un mélanome de stade avancé
Risk of recurrence after surgical resection remains high for patients with advanced melanoma. Novel approaches, such as neoadjuvant immunotherapies, may help establish a wide repertoire of antitumoral T-cell responses and enhance patient outcomes. Talimogene laherparepvec (T-VEC), an intralesional oncolytic viral immunotherapy, comprises genetically engineered herpes simplex virus type 1 that replicates in tumor cells and supports recruitment of T cells and natural killer cells. The phase 3 OPTiM trial of T-VEC monotherapy for advanced melanoma showed a significantly improved durable response over granulocyte-macrophage colony-stimulating factor (16.3% vs 2.1%; P < .001). Primary analysis of the safety and efficacy of neoadjuvant T-VEC (NCT02211131) demonstrated a 2-year recurrence-free survival (RFS) of 29.5% for T-VEC plus surgery and 16.5% for surgery alone (overall hazard ratio [HR], 0.75; 80% CI, 0.58-0.96) in patients with advanced, resectable melanoma, persisting at 3 years (overall HR, 0.74; 80% CI, 0.57-0.95). Here, we report the study’s final 5-year analysis.