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

Publication date: Aug 01, 2022

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 10 PFU/ml; after 3 weeks and then every 2 weeks thereafter, ≤4. 0 ml of 10 PFU/ml). Primary endpoints were dose-limiting toxicities (DLTs) and durable response rate (DRR). Of 18 enrolled patients (72. 2% female), 16 had received ≥1 prior line of therapy. Ten patients discontinued T-VEC due to disease progression. Median (range) follow-up was 20. 0 (4-37) months. No DLTs were observed; 17 (94. 4%) patients had treatment-emergent adverse events (AEs). Fourteen (77. 8%) patients had treatment-related AEs; the most frequent were pyrexia (44. 4%), malaise (16. 7%), chills, decreased appetite, pruritus, and skin ulcer (11. 1% each). The primary efficacy endpoint was met: 2 (11. 1%) patients had a durable partial response ≥6 months. The DRR was consistent with that observed in a phase III trial of T-VEC in non-Asian patients. The safety profile was consistent with the patients’ underlying disease and the known safety profile of T-VEC.

Concepts Keywords
2weeks Experimental cancer treatments
Australia Biotechnology
Hematologic Medicine
Japanese Clinical medicine
Stage Virotherapy
Life sciences
Amgen
Talimogene laherparepvec
Oncolytic virus
Melanoma
Oncolytic herpes virus

Semantics

Type Source Name
drug DRUGBANK Talimogene laherparepvec
disease MESH melanoma
pathway KEGG Melanoma
drug DRUGBANK Pentaerythritol tetranitrate
disease MESH disease progression
disease MESH skin ulcer
drug DRUGBANK Methionine
disease MESH Skin Neoplasms

Original Article

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