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Two-Year Survival Results With Neoadjuvant T-VEC in Resectable Melanoma

By: Sarah Campen, PharmD
Posted: Tuesday, January 7, 2020

The addition of talimogene laherparepvec (T-VEC) prior to surgery appears to improve 2-year recurrence-free and overall survival in patients with resectable stage IIIB–IVM1a melanoma, according to the primary analysis of an open-label, phase II trial. The study findings were presented at the 2019 International Congress of The Society for Melanoma Research in Salt Lake City.

“Increases in tumor inflammation after [treatment with] T-VEC support a role for the adaptive immune system consistent with the mechanism of action,” stated Reinhard Dummer, MD, of the University Hospital of Zurich in Zurich, Switzerland, and colleagues.

The oncolytic virus T-VEC directly infects and kills local tumor cells at the injection site and also exerts an immunotherapy effect through induction of local and systemic immune responses. In this study, 150 patients with no systemic treatment for at least 3 months prior to enrollment were randomly assigned to receive either intralesional T-VEC followed by surgery at week 13 (n = 76) or immediate surgery (n = 74).

At a median follow-up of 31.2 months, the 2-year overall survival rate in the T-VEC arm was 88.9% versus 77.4% with surgery alone (P = .05). More patients in the T-VEC arm than in the surgery arm remained free of recurrence at 2 years (29.5% vs. 16.5%, P = .07). Additionally, a threefold increase in intratumoral CD8-positive T cells was observed in patients who received T-VEC (P < .001); the mean CD8-positive density and PD-L1 H-scores after treatment were higher in the T-VEC arm as well.

Disclosure: For full disclosures of the study authors, visit societymelanomaresearch.org/congress.



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