EU approves Imlygic (talimogene laherparepvec) for metastatic melanoma- Amgen

Amgen has announced that the European Commission has approved the use of Imlygic (talimogene laherparepvec) for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a), with no bone, brain, lung or other visceral disease. Imlygic is the first oncolytic immunotherapy to demonstrate therapeutic benefit for patients with metastatic melanoma in a Phase III clinical trial.

The European approval included a review of exploratory subgroup analyses of Study 005/05, referred to as OPTiM. The durable response rate (DRR) in patients with Stage IIIB, IIIC and IVM1a disease was 25.2 percent compared to 1.2 percent in those treated with GM-CSF. In the study, patients with Stage IIIB, IIIC and IVM1a disease achieved an overall response rate (ORR) of 40.5 percent when treated with Imlygic compared to 2.3 percent with GM-CSF. The median overall survival (OS) for Imlygic patients with Stage IIIB, IIIC and IVM1a disease was 41.1 months compared to 21.5 months for patients treated with GM-CSF. While the pivotal study was not powered to evaluate efficacy in these individual subgroups, patients with no visceral disease derived greater benefit from Imlygic treatment than those with more advanced disease. Due to the exploratory nature of the analysis and based on the current evidence, it has not been established that Imlygic is associated with an effect on OS.

The most commonly reported treatment-related adverse events were fatigue, chills, pyrexia, nausea, influenza-like illness and injection-site pain. Overall, 98 percent of these adverse reactions reported were mild or moderate in severity. The most common grade 3 or higher adverse reaction was cellulitis. No fatal treatment-related adverse events occurred.