Talimogene Laherparepvec (T-VEC) for the Treatment of Advanced Locoregional Melanoma After Failure of Immunotherapy: An International Multi-Institutional Experience

• Published in: Annals of surgical oncology 2022-02, Vol.29 (2), p.791-801
• Main Authors: Carr, Michael J., Sun, James, DePalo, Danielle, Rothermel, Luke D., Song, Yun, Straker, Richard J., Baecher, Kristin, Louie, Raphael J., Stahlie, Emma H. A., Wright, G. Paul, Naqvi, Syeda Mahrukh Hussnain, Kim, Youngchul, Sarnaik, Amod A., Karakousis, Giorgos C., Lowe, Michael C., Delman, Keith A., van Akkooi, Alexander C. J., Ollila, David W., Collichio, Frances, Zager, Jonathan S.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Biological Products; Confidence intervals; Herpesvirus 1, Human; Humans; Immunotherapy; Male; Medicine; Medicine & Public Health; Melanoma; Melanoma - therapy; Metastases; Metastasis; Middle Aged; Neoplasm Recurrence, Local - therapy; Oncology; Oncolysis; Oncolytic Virotherapy; Patients; Skin Neoplasms - therapy; Surgery; Surgical Oncology; Survival; Vaccines; Young Adult
• ISSN: 1068-9265; 1534-4681
• DOI: 10.1245/s10434-021-10910-5

Background Talimogene laherparepvec (T-VEC) is an oncolytic virus approved for the treatment of unresectable, recurrent melanoma. The role of T-VEC after progression on systemic immunotherapy (IO) remains undefined. The goal of this study was to characterize the efficacy of T-VEC after failure of IO in patients with unresectable metastatic melanoma. Methods An international, multi-institutional review of AJCC version 8 stage IIIB-IV melanoma patients treated with T-VEC after failure of IO was performed at six centers from October 2015-December 2020. Primary outcome was in-field response; secondary outcomes included analyses of in-field and overall progression-free survival (PFS) and in-field and overall disease-free survival (DFS) after a complete response. Subset analysis of T-VEC initiation sequentially after or concurrently with IO was performed. Results Of 112 patients, median age at T-VEC initiation was 69 years (range 21–93); 65 (58%) were male. Before T-VEC, 57% patients received one IO regimen, 42% received two or more, with most patients ( n = 74, 66%) receiving T-VEC sequential to IO. Most were stage 3C ( n = 51, 46%) at T-VEC initiation, 29 (26%) received injections to nodal disease. Over median follow-up of 14 months, in-field response at final T-VEC injection was 37% complete (CR), 14% partial (PR). T-VEC initiation sequentially or concurrently did not significantly affect in-field response ( p = 0.26). Median in-field PFS was 15 months (95% confidence interval 4.6-NE). Median overall DFS after CR was 32 months (95% confidence interval 17-NE). Conclusions T-VEC after failure of IO is effective in unresectable, metastatic stage IIIB-IV melanoma. T-VEC initiation sequentially or concurrently did not significantly affect in-field response.