A phase I study of the safety and efficacy of talimogene laherparepvec in Japanese patients with advanced melanoma.

ABSTRACT: Talimogene laherparepvec (T-VEC) is approved for the treatment of unresectable melanoma in the USA, Europe, and Australia. This phase I, multicenter, open-label, dose de-escalation study evaluated the safety and efficacy of T-VEC in Japanese patients with unresectable stage IIIB-IV melanoma. Eligible adult patients had histologically confirmed stage IIIB-IVM1c cutaneous melanoma, may have received prior systemic anticancer therapy, must have had ≥1 injectable lesion, serum lactate dehydrogenase ≤1.5x upper limit of normal, ECOG performance status of 0 or 1, and adequate hematologic, hepatic, and renal function. T-VEC was injected intralesionally (first dose, ≤4.0 ml of 10⁶  PFU/ml; after 3 weeks and then every 2 weeks thereafter, ≤4.0 ml of 10⁸  PFU/ml). Primary endpo

SUBMITTER: Yamazaki N 

PROVIDER: S-EPMC9357627 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature