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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.


ABSTRACT: 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).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.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.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.

SUBMITTER: Andtbacka RH 

PROVIDER: S-EPMC5129499 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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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.

Andtbacka Robert H I RH   Agarwala Sanjiv S SS   Ollila David W DW   Hallmeyer Sigrun S   Milhem Mohammed M   Amatruda Thomas T   Nemunaitis John J JJ   Harrington Kevin J KJ   Chen Lisa L   Shilkrut Mark M   Ross Merrick M   Kaufman Howard L HL  

Head & neck 20160713 12


<h4>Background</h4>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).<h4>Methods</h4>Retrospective review of OPTiM identified patients with cutaneous hea  ...[more]

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