T-VEC Approved in Europe for Unresectable Metastatic Melanoma

Source: OncLive, December 2015

The European Commission has approved talimogene laherparepvec (T-VEC; Imlygic) as a treatment for adult patients with unresectable stage IIIb, IIIc, and IVM1a melanoma that has not spread to the bone, brain, lung, or other viscera, based on the phase III OPTiM study.

In the study, T-VEC significantly extended durable response rates (DRR) compared with GM-CSF. The DRR with T-VEC in those with stage IIIb, IIIc, and IVM1a melanoma was 25.2% versus 1.2% with GM-CSF. In these same groups, median overall survival (OS) was 41.1 months with T-VEC compared with 21.5 months with GM-CSF; however, the study was not designed to look specifically at these groups.

“As the first oncolytic immunotherapy authorized in the European Union, the approval of Imlygic is an important milestone for this new class of drugs, bringing patients with a rare and deadly form of skin cancer a much needed new treatment option,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in a statement. “By igniting the body’s own immune system Imlygic can initiate an anti-tumor immune response, providing meaningful and durable response rates in the early stage metastatic melanoma patient.”