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Multicenter Study
. 2021 Feb;9(2):e001701.
doi: 10.1136/jitc-2020-001701.

Real-life use of talimogene laherparepvec (T-VEC) in melanoma patients in centers in Austria, Switzerland and Germany

Julia Maria Ressler  1 , Matthias Karasek  2 , Lukas Koch  3 , Rita Silmbrod  4 , Joanna Mangana  5 , Sofiya Latifyan  6 , Veronica Aedo-Lopez  6 , Helmut Kehrer  7 , Felix Weihsengruber  8 , Peter Koelblinger  9 , Christian Posch  10 , Julian Kofler  11 , Olivier Michielin  6 , Erika Richtig  3 , Christine Hafner  2 , Christoph Hoeller  4
Affiliations
Multicenter Study

Real-life use of talimogene laherparepvec (T-VEC) in melanoma patients in centers in Austria, Switzerland and Germany

Julia Maria Ressler et al. J Immunother Cancer. 2021 Feb.

Erratum in

Abstract

Background: Talimogene laherparepvec (T-VEC) is a licensed therapy for use in melanoma patients of stage IIIB-IVM1a with injectable, unresectable metastatic lesions in Europe. Approval was based on the Oncovex Pivotal Trial in Melanoma study, which also included patients with distant metastases and demonstrated an overall response rate (ORR) of 40.5% and a complete response (CR) rate of 16.6%.

Objectives: The aim of this study was to assess the outcome of melanoma patients treated with T-VEC in a real-life clinical setting.

Methods: Based on data from 10 melanoma centers in Austria, Switzerland and southern Germany, we conducted a retrospective chart review, which included 88 patients (44 male, 44 female) with a median age of 72 years (range 36-95 years) treated with T-VEC during the period from May 2016 to January 2020.

Results: 88 patients fulfilled the inclusion criteria for analysis. The ORR was 63.7%. 38 patients (43.2%) showed a CR, 18 (20.5%) had a partial response, 8 (9.1%) had stable disease and 24 (27.3%) patients had a progressive disease. The median treatment period was 19 weeks (range: 1-65), an average of 11 doses (range: 1-36) were applied. 39 (45.3%) patients developed adverse events, mostly mild, grade I (64.1%).

Conclusion: This real-life cohort treatment with T-VEC showed a high ORR and a large number of durable CRs.

Keywords: immunotherapy; melanoma; oncolytic virotherapy; oncolytic viruses.

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Conflict of interest statement

Competing interests: JMR received project funding by Amgen, Speakers bureau of Amgen and Bristol Myers Squibb and travel support from Bristol Myers Squibb, Pierre Fabre outside of the submitted work. JMR has intermittent project focused consultant or advisory relationships with Merck/Pfizer, Merck Sharp & Dohme, Amgen, Novartis, Bristol Myers and Squibb and Pierre Fabre and has received travel support from Ultrasun, L’ oreal, Merck Sharp & Dohme, Bristol Myers and Squibb and Pierre Fabre outside of the submitted work. PK has received honoraria for travel/congress support and consulting/advisory roles for Roche, Bristol Myers Squibb (BMS), Merck Sharp and Dome (MSD), Novartis, Amgen, Pierre Fabre and Sanofi Aventis unrelated to the submitted work. ER Honoraria, consulting or advisory role: Amgen, Bayer, Bristol Myers Squibb, MSD, Merck, Novartis, Pierre Fabre, Roche, SanofiSpeakers'bureau: Amgen, Bristol Myers Squibb, MSD, Merck, Novartis, Pierre Fabre, SanofiResearch funding site PI: Amgen, Bristol Myers Squibb, MSD, Novartis, Pierre Fabre, Roche Research funding steering committee: Novartistravel, accommodations, expenses: Amgen, Bristol Myers Squibb, MSD, Merck, Novartis, Pierre Fabre, Roche, Sanofi. CH is associated with consulting or advisory role for Bristol-Myers Squibb, Amgen, Merck Sharp and Dohme, Novartis, Pierre Fabre and Speaker’s bureau of Bristol-Myers Squibb, Amgen, Merck Sharp & Dohme, Pierre Fabre and received travel/accommodations/expenses from Amgen, Bristol-Myers Squibb, Merck Sharp and Dohme, Pierre Fabre.C.HO. is associated with advisory role for Advisory Boards: Amgen, Astra Zeneca, BMS, Inzyte, MSD, Novartis, Pierre Fabre, Roche and Speakers bureau of Amgen, BMS, MSD, Novartis, Roche.

Figures

Figure 1
Figure 1
Flow chart of patients from centers in Austria, Switzerland and Germany included in the study. T-VEC, Talimogene laherparepvec.
Figure 3
Figure 3
Time to response. Median time to response was 4 months=124 days (range: 44–397 days).
Figure 4
Figure 4
Kaplan-Maier analysis of PFS. One-year PFS was 45%, 2-year PFS was 35% and 3-year PFS was 28%. Median PFS was 9 months (95% CI 5.9 to 10.1) (A). Kaplan-Maier analysis of PFS according to disease stage (B). PFS according to first and second line treatment with Talimogene laherparepvec (T-VEC) (C). T-VEC, Talimogene laherparepvec.
Figure 5
Figure 5
Kaplan-Maier analysis of OS. One-year OS was 82%, 2-year OS was 71%, 3-year OS was 65% and 4-year OS was 65%. Median OS was not reached (A). Kaplan-Maier analysis of OS according to disease stage (B). OS according to first and second line treatment with tlimogene laherparepvec (T-VEC) (C). Kaplan-Maier analysis of PFS. One-year PFS was 45%, 2-year PFS was 35% and 3-year PFS was 28%. Median PFS was 9 months (95% CI 5.9 to 10.1) (A).
Figure 2
Figure 2
Talimogene laherparepvec (T-VEC) treatment over the years 2016–2020, in 10 melanoma centers in Austria, Switzerland and Germany. CPI, checkpoint inhibitors.
Figure 6
Figure 6
PFS of patients on concurrent therapy with checkpoint inhibitors (CPI) and talimogene laherparepvec (T-VEC). One-year PFS was 68%, 2-year PFS was 34%. The median PFS was 13 months (95% CI 10.0 to 15.3) (A). OS of patients on concurrent therapy with CPI and T-VEC. One-year OS was 70% and the 2- year OS was 56%. The median OS was not reached (B).
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