Cutaneous head and neck melanoma in OPTiM, a randomized phase 3 trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor for the treatment of unresected stage IIIB/IIIC/IV melanoma.
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Embargo End Date
ICR Authors
Authors
Andtbacka, RHI
Agarwala, SS
Ollila, DW
Hallmeyer, S
Milhem, M
Amatruda, T
Nemunaitis, JJ
Harrington, KJ
Chen, L
Shilkrut, M
Ross, M
Kaufman, HL
Agarwala, SS
Ollila, DW
Hallmeyer, S
Milhem, M
Amatruda, T
Nemunaitis, JJ
Harrington, KJ
Chen, L
Shilkrut, M
Ross, M
Kaufman, HL
Document Type
Journal Article
Date
2016-12-01
Date Accepted
2016-05-16
Abstract
BACKGROUND: Cutaneous head and neck melanoma has poor outcomes and limited treatment options. In OPTiM, a phase 3 study in patients with unresectable stage IIIB/IIIC/IV melanoma, intralesional administration of the oncolytic virus talimogene laherparepvec improved durable response rate (DRR; continuous response ≥6 months) compared with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). METHODS: Retrospective review of OPTiM identified patients with cutaneous head and neck melanoma given talimogene laherparepvec (n = 61) or GM-CSF (n = 26). Outcomes were compared between talimogene laherparepvec and GM-CSF treated patients with cutaneous head and neck melanoma. RESULTS: DRR was higher for talimogene laherparepvec-treated patients than for GM-CSF treated patients (36.1% vs 3.8%; p = .001). A total of 29.5% of patients had a complete response with talimogene laherparepvec versus 0% with GM-CSF. Among talimogene laherparepvec-treated patients with a response, the probability of still being in response after 12 months was 73%. Median overall survival (OS) was 25.2 months for GM-CSF and had not been reached with talimogene laherparepvec. CONCLUSION: Treatment with talimogene laherparepvec was associated with improved response and survival compared with GM-CSF in patients with cutaneous head and neck melanoma. © 2016 Wiley Periodicals, Inc. Head Neck 38: 1752-1758, 2016.
Citation
Head & neck, 2016, 38 (12), pp. 1752 - 1758
Source Title
Publisher
WILEY
ISSN
1043-3074
eISSN
1097-0347
Research Team
Targeted Therapy