Amgen announced interim overall survival (OS) results from a pivotal Phase 3 trial evaluating talimogene laherparepvec in patients with unresected stage IIIB, IIIC, or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). Talimogene laherparepvec (T-VEC) is an oncolytic immunotherapy derived from the herpes simplex virus type-1, designed to selectively replicate within tumors and to express human GM-CSF, which enhances systemic antitumor immune responses.
The trial was a global, randomized, open-label trial designed to evaluate the safety and efficacy of talimogene laherparepvec compared to a control therapy with GM-CSF in over 400 patients with unresected stage IIIB, IIIC or IV melanoma. Patients were randomized 2:1 to receive either talimogene laherparepvec intralesionally every two weeks or GM-CSF subcutaneously for the first 14 days of each 28 day cycle. Treatment could last for up to 18 months. Where appropriate, stable or responding patients could receive additional treatment on an extension protocol.
At a predefined interim analysis of this Phase 3 study, median OS was 23.3 months in the talimogene laherparepvec arm over 19.0 months in the GM-CSF arm (HR=0.79, 95% CI 0.61–1.02; P=0.0746). Differences in survival rates were pronounced in the subset of patients with stage IIIB, IIIC or IV M1a disease (HR=0.56, 95% CI, 0.38–0.81) or who received talimogene laherparepvec as first-line treatment (HR=0.49, 95% CI, 0.33–0.74), each comprising approximately 50% of the study population.
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