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FDA Approves T-VEC for Advanced Melanoma

Jason M. Broderick @jasoncology
Published: Tuesday, Oct 27, 2015

Dr. Karen Midthun

Karen Midthun, MD

The FDA has approved the first-in-class oncolytic immunotherapy talimogene laherparepvec (T-VEC; Imlygic) for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery, based on results from the phase III OPTiM study.

There were 12 patient deaths within 30 days of the last dose of T-VEC, including 10 in the primary OPTiM study and 2 in an extension of the study. Nine of the deaths were associated with progressive disease, with the remaining three attributed to myocardial infarction, cardiac arrest, and sepsis. There were four patient deaths in the GM-CSF arms, two each in the primary and extension analyses.

"Imlygic is the first clinical and regulatory validation of an oncolytic virus as a therapy, which Amgen is proud to bring to patients with a serious form of skin cancer,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in a statement. “Not all melanoma patients currently benefit from available therapies, and Imlygic represents an important new option that can provide meaningful durable responses for patients with this aggressive and complex disease."

T-VEC is engineered through the genetic alteration of the herpes simplex 1 virus to secrete the cytokine GM-CSF within the tumor, causing cell lysis.

Multiple clinical trials are currently assessing T-VEC in combination with immune checkpoint inhibitors. A phase I/II study is assessing T-VEC with ipilimumab for unresected melanoma (NCT01740297). Additionally, a phase III study is currently exploring T-VEC with pembrolizumab for unresected melanoma (NCT02263508).

"Immunotherapy is an exciting area for cancer research, and we are currently studying Imlygic in combination with other immunotherapies in advanced melanoma and other solid tumors," said Harper.

Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma [Published online May 26, 2015]. J Clin Oncol. doi: 10.1200/JCO.2014.58.3377

 

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View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: New Directions in Advanced Cutaneous Squamous Cell Carcinoma: Emerging Evidence of ImmunotherapyAug 13, 20191.5
Advances in™ Melanoma: Exploring BRAF/MEK in Adjuvant and Neoadjuvant SettingsSep 28, 20191.5
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