Real-World Study Shows High Response Rates to T-VEC in Early Metastatic Melanoma
T-VEC elicited substantially higher ORR in a real-world population compared with the rate that was seen in the drug maker’s phase 3 trial.
|The following article features coverage from the European Society for Medical Oncology (ESMO) 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Treatment with talimogene laherparepvec (T-VEC) resulted in a substantially higher response rate in a real-world study of patients with early metastatic melanoma compared with the results observed during the phase 3 OPTiM study, according to presentation at the the ESMO 2018 Congress in Munich, Germany.1
Intralesional treatment of stage IIIB/C-IVM1a unresectable melanoma with T-VEC resulted in an overall response rate (ORR) of 26% in the phase 3 OPTiM study. The purpose of this study was to evaluate the efficacy and safety of T-VEC in a real-world Netherlands population since December 2016, when the biopharmaceutical was approved there.
The study included 23 patients with a mean number of lesions at baseline of 5 to 50. All patients had previously undergone surgical resection, and other prior therapies included isolated limb perfusion, targeted therapy, immunotherapy, and radiotherapy.
During a median follow-up of 11.3 months, the ORR was 82.6% and the disease control rate was 91.3%. Complete response was achieved by 52% of patients; all except 1 were ongoing after treatment discontinuation. The best response was a partial response in 30.4% of patients, mixed response in 8.7%, and progressive disease in 8.7%.
Response or toxicity to T-VEC was not affected by administration of prior therapies.
All patients experienced grade 1 to grade 2 adverse events (AEs) consisting of fatigue, influenza-like symptoms, and pain at the injection site. A case of grade 3 or higher colitis resulted in treatment interruption.
These data suggest a substantially higher ORR with T-VEC compared with its clinical trial. The authors concluded that this “confirms the role of oncolytic immunotherapy for melanoma.”
Disclosure: Research funding for this study was provided by Amgen. For a full list of disclosure, please see the abstract link.
Read more of Cancer Therapy Advisor's coverage of the ESMO 2018 meeting by visiting the conference page.
- Franke V, Berger DMS, Klop WMC, et al. High response rate with T-VEC in early metastatic melanoma (stage IIIB/C-IVM1a). Presented at: the ESMO 2018 Congress; Munich, Germany: October 19-23, 2018. Abstract 1253P.