In a nutshell
This study investigated the effectiveness of talimogene laherparepvec (Imlygic; T-VEC) with ipilimumab (Yervoy) in the treatment of inoperable stage 3 or 4 melanoma. Researchers concluded that this combination improves melanoma outcomes, with manageable side effects.
Immunotherapy has become an important treatment option in melanoma. Different immunotherapies work through different mechanisms. Ipilimumab is an immunotherapy that activates immune system cells (T-cells) to combat and kill tumor cells. T-VEC is a recently approved melanoma therapy. T-VEC is a type of virus that is injected directly into the tumor. This can lead to an immune response, killing the tumor cells. It is not clear whether the combination of T-VEC with ipilimumab can improve melanoma outcomes.
Methods & findings
The aim of this study was to investigate the effectiveness of the combined treatment with T-VEC and ipilimumab in inoperable stage 3 or 4 melanoma.
This study included 19 patients with untreated inoperable melanoma. Patients received T-VEC on day 1 of week 1 and on day 1 of week 4, then every 2 weeks. Patients received ipilimumab on day 1 of week 6, then every 3 weeks for four doses. The average follow-up period was 20 months. The tumor response to the treatment, immune-response to treatment and side effects were measured.
50% of patients responded to the treatment. 44% of patients had a durable response lasting up to 6 months or more. 50% of patients were disease progression-free at 18 months. 18-month overall survival (time from treatment until death from any cause) was 67%.
Moderate side effects were detected in 26.3% of the patients. The most common effect was nausea and increased levels of the proteins lipase and amylase (an indication that the pancreas is not functioning normally). 15.8% of these side effects were due to treatment with T-VEC and 21.1% due to the treatment with ipilimumab.
The bottom line
This study suggested that the combined treatment with T-VEC and ipilimumab improved the outcomes of inoperable melanoma, with manageable side effects.
The fine print
This study was funded by Amgen Inc., the producer of T-VEC.
Published By :
Journal of clinical oncology
Jun 13, 2016