Abstract 5303
Background
Talimogene Laherparepvec (TVEC), a genetically modified GM-CSF expressing HSV1 Virus that preferentially replicates in tumor cells is approved in Europe for use in melanoma patients with injectable metastatic lesions in stage III-IVM1a. Approval was based on the OPTIM study which did also include patients with distant metastases and demonstrated a ORR of 40.5% and a CR rate of 16.6%. The aim of this study was to assess the outcome of melanoma patients treated with TVEC in a real life clinical setting outside of clinical studies.
Methods
To this aim a retrospective chart review in 7 melanoma centers in Austria and 1 center in Switzerland was conducted and anonymized data on disease stage, treatment duration, treatment response by investigator assessment following RECIST 1.1, tolerability as well as data on follow up therapies was collected.
Results
A total of 62 patients received TVEC since December of 2016. The majority of patients were AJCC stage IIIB and IIIC. Two patients with stage IV M1b and M1d who had complete control of their distant metastases and a locoregional progression were treated in parallel with a PD-1 antibody in one case and in parallel with a BRAF/MEK inhibitor combination in the other. In 3 other cases TVEC was used in combination with a PD-1 inhibitor as first-line of therapy. The median number of intralesional injection cycles was 11. The ORR was 67,7%; 50% of patients achieved a complete remission. 7 of 31 patients with a CR had a subsequent progression, 4 with distant and 3 with locoregional metastases. The main side effects observed were fever and chills.
Conclusions
In this real life cohort treatment of TVEC shows a high overall and complete remission rate with the majority of complete responses being durable.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
C. Hoeller: Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen. J.M. Ressler: Speaker Bureau / Expert testimony: Amgen. H. Kehrer: Advisory / Consultancy: Amgen. P. Koelblinger: Advisory / Consultancy: Amgen. F. Weihsengruber: Advisory / Consultancy: Amgen. J. Kofler: Advisory / Consultancy: Amgen. E. Richtig: Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen. O.A. Michielin: Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen. C. Hafner: Advisory / Consultancy: Amgen. All other authors have declared no conflicts of interest.
Resources from the same session
5678 - Nanomaterials Augmented LDI-TOF-MS for Hepatocellular Carcinoma Diagnosis and Classification
Presenter: Jian Zhou
Session: Poster Display session 3
Resources:
Abstract
2436 - Development and Validation of an RNA-Seq Assay for Gene Fusions Detection in Formalin-Fixed Paraffin-Embedded Samples
Presenter: Hua Dong
Session: Poster Display session 3
Resources:
Abstract
5271 - A Pilot Study to Implement an Artificial Intelligence (AI) System for Gastrointestinal Cancer Clinical Trial Matching
Presenter: Zhaohui Jin
Session: Poster Display session 3
Resources:
Abstract
4787 - A Blinded Comparison of Patient Treatments to Therapeutic Options Presented by an Artificial Intelligence-based Clinical Decision-support system
Presenter: Suthida Suwanvecho
Session: Poster Display session 3
Resources:
Abstract
5744 - OncOS: scalable and accurate next-generation sequencing analytics for precision oncology and personalized patient care
Presenter: Joe Thompson
Session: Poster Display session 3
Resources:
Abstract
3752 - The association between wearable device physical activity metrics and performance status in oncology: a systematic review
Presenter: Milan Kos
Session: Poster Display session 3
Resources:
Abstract
5820 - SomaticNET: neural network evaluation of somatic mutations in cancer
Presenter: Geoffroy Dubourg-Felonneau
Session: Poster Display session 3
Resources:
Abstract
4771 - Is there a role for Next-generation sequencing (NGS) profiling on metastatic non-colorectal gastrointestinal carcinomas (MNCGIC) in developing countries? A single center experience.
Presenter: Mauricio Ribeiro
Session: Poster Display session 3
Resources:
Abstract
1209 - Metastatic Cancer Whole-Exome Sequencing in daily practice
Presenter: Manon Réda
Session: Poster Display session 3
Resources:
Abstract
5702 - Genomic-Guided Individualized Precision Therapy in Refractory Metastatic Solid Tumor Patients with Extensively Poor Performance Status: A Chinese single institutional prospective observational real-world study
Presenter: Haitao Wang
Session: Poster Display session 3
Resources:
Abstract