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Talimogene laherparepvec (T-VEC) is a modified herpes simplex virus, type 1, intralesionally administered in patients with stage IIIB/C-IVM1a unresectable melanoma. When surgery is not a treatment option in the head and neck region, T-VEC can be an elegant alternative to systemic immunotherapy. Ten patients with metastatic melanoma in the head and neck region started treatment with T-VEC monotherapy at the Netherlands Cancer Institute. We collected data on response, adverse events (AEs), and baseline characteristics. For response evaluation, we used clinical evaluation with photography, 3-monthly PET/computed tomography (PET/CT) using 18F-fluoro-2-D-deoxyglucose, and histological biopsies. Median age at baseline was 78.2 (35-97) years with a median follow-up of 11.6months. Of these 10 patients, 5 had a complete response (CR), 3 had a partial response, 1 had stable disease and 1 showed progressive disease (PD) as their best response. Best overall response rate (ORR) was 80%. Median progression-free survival was 10.8 months (95% confidence interval, 2.2-19.4). Grade 1 AEs occurred in all patients. Mostly, these consisted of fatigue, influenza-like symptoms, and injection site pain. PET-CT and histological biopsies proved to be clinically useful tools to evaluate treatment response for T-VEC monotherapy, confirming pCR or PD to stage IV disease requiring systemic treatment. ORR for T-VEC monotherapy for melanoma in the head and neck region at our institute was 80% with 50% achieving a CR. This realworld data demonstrates promising results and suggests T-VEC can be an alternative to systemic therapy in this select, mostly elderly patient population.

Titel:	Talimogene laherparepvec monotherapy for head and neck melanoma patients.
Autor/in / Beteiligte Person:	Franke, V ; Stahlie, EHA ; Klop, WMC ; Zuur, CL ; Berger, DMS ; van der Hiel B ; van de Wiel BA ; Wouters, MWJM ; van Houdt WJ ; van Akkooi ACJ
Zeitschrift:	Melanoma research, Jg. 33 (2023-02-01), Heft 1, S. 66-70
Veröffentlichung:	London : Lippincott Williams & Wilkins ; <i>Original Publication</i>: Oxford, UK : Rapid Communications of Oxford, 1991-, 2023
Medientyp:	academicJournal
ISSN:	1473-5636 (electronic)
DOI:	10.1097/CMR.0000000000000866
Schlagwort:	Humans Aged Aged, 80 and over Positron Emission Tomography Computed Tomography Immunotherapy methods Melanoma pathology Skin Neoplasms pathology Oncolytic Virotherapy adverse effects
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article Language: English [Melanoma Res] 2023 Feb 01; Vol. 33 (1), pp. 66-70. <i>Date of Electronic Publication: </i>2022 Nov 29. MeSH Terms: Melanoma* / pathology ; Skin Neoplasms* / pathology ; Oncolytic Virotherapy* / adverse effects ; Humans ; Aged ; Aged, 80 and over ; Positron Emission Tomography Computed Tomography ; Immunotherapy / methods References: Kaufman HL, Bines SD. OPTIM trial: a phase III trial of an oncolytic herpes virus encoding GM-CSF for unresectable stage III or IV melanoma. Future Oncol 2010; 6:941–949. ; Chesney J, Puzanov I, Collichio F, Singh P, Milhem MM, Glaspy J, et al. Randomized, open-label phase II study evaluating the efficacy and safety of talimogene laherparepvec in combination with ipilimumab versus ipilimumab alone in patients with advanced, unresectable melanoma. J Clin Oncol 2018; 36:1658–1667. ; Rehman H, Silk AW, Kane MP, Kaufman HL. Into the clinic: talimogene laherparepvec (T-VEC), a first-in-class intratumoral oncolytic viral therapy. J ImmunoTher Cancer 2016; 4:53. ; Haitz K, Khosravi H, Lin JY, Menge T, Nambudiri VE. Review of talimogene laherparepvec: a first-in-class oncolytic viral treatment of advanced melanoma. J Am Acad Dermatol 2020; 83:189–196. ; Shashanka R, Smitha BR. Head and neck melanoma. ISRN Surg 2012; 2012:948302. ; Yde SS, Sjoegren P, Heje M, Stolle LB. Mucosal melanoma: a literature review. Curr Oncol Rep 2018; 20:28. ; Andtbacka RH, Agarwala SS, Ollila DW, Hallmeyer S, Milhem M, Amatruda T, et al. 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. Head Neck 2016; 38:1752–1758. ; Bradford CR, Levine PA. Incidence and prognosis of cutaneous melanoma involving the head and neck. JAMA 2007; 297:2628–2629. ; Fadaki N, Li R, Parrett B, Sanders G, Thummala S, Martineau L, et al. Is head and neck melanoma different from trunk and extremity melanomas with respect to sentinel lymph node status and clinical outcome? Ann Surg Oncol 2013; 20:3089–3097. ; Franke V, van der Hiel B, van de Wiel BA, Klop WMC, Ter Meulen S, van Akkooi ACJ. Positron emission tomography/computed tomography evaluation of oncolytic virus therapy efficacy in melanoma. Eur J Cancer 2018; 90:149–152. ; Franke V, Berger DMS, Klop WMC, van der Hiel B, van de Wiel BA, Ter Meulen S, et al. High response rates for T-VEC in early metastatic melanoma (stage IIIB/C-IVM1a). Int J Cancer 2019; 145:974–978. ; Louie RJ, Perez MC, Jajja MR, Sun J, Collichio F, Delman KA, et al. Real-world outcomes of talimogene laherparepvec therapy: a multi-institutional experience. J Am Coll Surg 2019; 228:644–649. ; Hoeller C, Ressler JM, Karasek M, Hafner C. Real life use of talimogene laherparepvec in melanoma in centres in Austria and Switzerland. ESMO. J Immunother Cance r 2021; 9:e001701. ; Franke V, Stahlie EHA, Hiel B, Wiel BA, Wouters MWJM, Houdt WJ, et al. Re-introduction of T-VEC monotherapy in recurrent stage IIIB/C-IVM1a melanoma is effective. J Immunother 2022;45: 263–266. ; Ribas A, Dummer R, Puzanov I, VanderWalde A, Andtbacka RHI, Michielin O, et al. Oncolytic virotherapy promotes intratumoral t cell infiltration and improves anti-PD-1 immunotherapy. Cell 2017; 170:1109–19 e10. ; Andtbacka RH, Dummer R, Gyorki DE, Berger AC, Conry RM, Demidov LV, et al. Interim analysis of a randomized, open-label phase 2 study of talimogene laherparepvec (T-VEC) neoadjuvant treatment (neotx) plus surgery (surgx) vs surgx for resectable stage IIIB-IVM1a melanoma (MEL). J Clin Oncol 2018; 36(Suppl 1):9508. Substance Nomenclature: 0 (talimogene laherparepvec) Entry Date(s): Date Created: 20221201 Date Completed: 20221223 Latest Revision: 20230325 Update Code: 20231215

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Talimogene laherparepvec monotherapy for head and neck melanoma patients.