Real-World Study Shows High Response Rates to T-VEC in Early Metastatic Melanoma

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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.
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.

Reference

  1. 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.

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