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

BackgroundCutaneous 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).MethodsRetrospective 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.ResultsDRR 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.ConclusionTreatment 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

Oncolytic virotherapy for small-cell lung cancer induces immune infiltration and prolongs survival

“…In addition, there is growing recognition that oncolytic viruses have the potential to generate new antitumor host immune responses (23). For example, a conditionally replicative modified herpes viral vector expressing GM-CSF was the first oncolytic virus approved by the FDA, after demonstrating efficacy in a phase III clinical study in patients with advanced unresectable melanoma (24,25). Further, recent data using this vector (talimogene laherparepvec)…”

Performance of a 31‐gene expression profile test in cutaneous melanomas of the head and neck

“…In conclusion, the early detection of distant metastases is of particular importance for patients with cutaneous melanoma in the head and neck region, as surgical resection can be limited by both technical and cosmetic concerns and regional treatment options may be limited due to anatomic site. 36,37 Furthermore, regional head and neck melanoma is often well controlled by operation (the head and neck was the only site for which completion node dissection offered improved OS in the MSLT-II trial). 38 Thus, the addition of the 31-GEP test to standard staging offers the opportunity to complement node status and identify more patients at risk for distant metastasis and death who could potentially benefit from more aggressive surveillance and earlier therapeutic intervention, [34][35][36] at a point when these treatments are most effective.…”

Replicon RNA Viral Vectors as Vaccines

“…Clearly, adenovirus-based vaccine development and gene therapy has a longer history, which has generated a multitude [130] of vector improvements and also resulted a number of clinical trials [131,132]. Similarly, herpes simplex virus (HSV) vectors have been frequently applied and HSV-GM-CSF have, for instance, been subjected to phase I−III human clinical trials in glioblastoma and melanoma patients [133]. HSV vectors were recently approved by the FDA for use in standard patient care [134].…”