Amgenmrecently announced that the Committee for Medicinal Products for Human Use (CHMP) released a positive opinion recommending IMLYGIC (talimogene laherparepvec) can be used to treat adults with unresectable melanoma that is provincially or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no lung, brain, bone, or other disease affecting the viscera.
If IMLYGIC is granted with the European Commission (EC) approval, it would be the first in a class of new drug agents called oncolytic immunotherapies. IMLYGIC (Talimogene laherparepvec), often called “T-VEC,” is a cancer-killing (oncolytic) virus currently being studied for the treatment of melanoma and other advanced cancers. The agent, administered via intralesional injection, is designed to cause the death of melanoma tumor cells and initiate an anti-tumor immune system response.
“We are pleased that IMLYGIC has received a positive opinion from the CHMP, and if approved by the European Commission, we look forward to continuing to work with European regulatory authorities to bring this innovative therapy to patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Metastatic melanoma continues to be one of the most difficult-to-treat cancers, often requiring the use of multiple treatment modalities. Despite recent advances, the five-year survival rate for patients who cannot be cured with surgery remains unacceptably low, demonstrating the critical need for additional approaches to control this disease.”
The CHMP’s recommendation draws from the findings of a global, randomized, open-label 436-patient Phase 3 clinical trial that evaluated the efficacy and safety profile of the intralesional injectable in patients with unresectable Stage IIIB, IIIC or IV melanoma, compared to treatment with a granulocyte-macrophage colony-stimulating factor (GM-CSF). The study achieved its primary endpoint, with IMLYGIC demonstrating significantly improved durable response rate (DRR), which is the proportion of patients that exhibited a complete response (CR) or partial response (PR) that was maintained for at least six months. The secondary endpoint was defined as patients’ overall survival (OS).
The most frequently reported adverse events related with the treatment were nausea, pyrexia, fatigue, chills, injection-site pain, and illness resembling influenza. Ninety-eight percent of these adverse events were moderate or mild in terms of severity. The most frequent grade 3 or higher adverse events was cellulitis.
Malignant melanoma is a skin cancer type that although accounting for less than 2% of all skin cancer cases, is considered the deadliest type, responsible for the vast majority of melanoma deaths. After CHMP’s positive opinion, the company is expecting a conclusion on the Marketing Authorization from the EC during the next upcoming months. IMLYGIC is also under evaluation by the U.S. Food and Drug Admnistration (FDA).
