TY - JOUR
T1 - Real-life use of talimogene laherparepvec (T-VEC) in melanoma patients in centers in Austria, Switzerland and Germany
AU - Ressler, Julia Maria
AU - Karasek, Matthias
AU - Koch, Lukas
AU - Silmbrod, Rita
AU - Mangana, Joanna
AU - Latifyan, Sofiya
AU - Aedo-Lopez, Veronica
AU - Kehrer, Helmut
AU - Weihsengruber, Felix
AU - Koelblinger, Peter
AU - Posch, Christian
AU - Kofler, Julian
AU - Michielin, Olivier
AU - Richtig, Erika
AU - Hafner, Christine
AU - Hoeller, Christoph
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2021.
PY - 2021/2/19
Y1 - 2021/2/19
N2 - 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.
AB - 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.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Biological Products/adverse effects
KW - Disease Progression
KW - Europe
KW - Female
KW - Herpesvirus 1, Human/immunology
KW - Humans
KW - Male
KW - Melanoma/immunology
KW - Middle Aged
KW - Neoplasm Staging
KW - Oncolytic Viruses/immunology
KW - Retrospective Studies
KW - Skin Neoplasms/immunology
KW - Time Factors
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85101193852&partnerID=8YFLogxK
U2 - 10.1136/jitc-2020-001701
DO - 10.1136/jitc-2020-001701
M3 - Journal article
C2 - 33608376
SN - 2051-1426
VL - 9
JO - Journal for ImmunoTherapy of Cancer
JF - Journal for ImmunoTherapy of Cancer
IS - 2
M1 - e001701
ER -