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J Immunother Cancer. 2016 Mar 15;4:12. doi: 10.1186/s40425-016-0116-2. eCollection 2016.

Systemic versus local responses in melanoma patients treated with talimogene laherparepvec from a multi-institutional phase II study.

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Rutgers Cancer Institute of New Jersey, 195 Little Albany Street, Room 2004, New Brunswick, NJ 08901 USA.
Minnesota Oncology, Fridley, MN USA.
University of California San Diego Medical Center, La Jolla, CA USA.
University of Colorado Cancer Center, Aurora, CO USA.
UCLA Jonsson Comprehesive Cancer Center, Los Angeles, CA USA.
Carol G. Simon Cancer Center, Morristown, NJ USA.
The Institute of Cancer Research/Royal Marsden NIHR Biomedical Research Centre, London, UK.
Mary Crowley Cancer Research Centers, Dallas, TX USA.
Amgen Inc., Thousand Oaks, CA USA.



We previously reported that talimogene laherparepvec, an oncolytic herpes virus encoding granulocyte-macrophage colony-stimulating factor (GM-CSF), resulted in an objective response rate of 26 % in patients with advanced melanoma in a phase II clinical trial. The response of individual lesions, however, was not reported. Since talimogene laherparepvec is thought to mediate anti-tumor activity through both direct tumor cytolysis and induction of systemic tumor-specific immunity, we sought to determine the independent response rate in virus-injected and non-injected lesions.


Fifty patients with stage IIIC or IV melanoma were treated with talimogene laherparepvec in a multi-institutional single-arm open-label phase II clinical trial. In this study patients were treated until a complete response was achieved, all accessible tumors disappeared, clinically significant disease progression, or unacceptable toxicity. This report is a post hoc analysis of the systemic effects of talimogene laherparepvec in injected lesions and two types of uninjected lesions-non-visceral lesions and visceral lesions.


Eleven of 23 patients (47.8 %) had a ≥ 30 % reduction in the total burden of uninjected non-visceral lesions, and 2 of 12 patients (16.7 %) had a ≥ 30 % reduction in the total burden of visceral lesions. Among 128 evaluable lesions directly injected with talimogene laherparepvec, 86 (67.2 %) decreased in size by ≥ 30 % and 59 (46.1 %) completely resolved. Of 146 uninjected non-visceral lesions, 60 (41.1 %) decreased in size by ≥ 30 %, the majority of which (44 [30.1 %]) completely resolved. Of 32 visceral lesions, 4 (12.5 %) decreased in size by ≥ 30 %, and 3 (9.4 %) completely resolved. The median time to lesion response was shortest for lesions that were directly injected (18.4 weeks), followed by uninjected non-visceral lesions (23.1 weeks) and visceral lesions (51.3 weeks), consistent with initiation of a delayed regional and systemic anti-tumor immune response to talimogene laherparepvec.


These results support a regional and systemic effect of talimogene laherparepvec immunotherapy in patients with advanced melanoma.


Herpes virus; Immunotherapy; Melanoma; Oncolytic virus; T-VEC; Talimogene laherparepvec

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