T-VEC's action was validated through a phase III, multicenter, open-label, randomized clinical trial known as OPTiM, which compared T-VEC to GM-CSF in patients with advanced melanoma that was not able to be removed surgically. The aim of the study was to determine durable response rate, defined as the percentage of patients with a complete or partial response maintained continuously for at least six months. Out of 436 patients enrolled in the study, 16.3 percent treated with T-VEC achieved a durable response compared to 2.1 percent treated with GM-CSF. Of those who had a durable response, 29.1 percent had a complete response, while 70.8 percent had a partial response.
Dr. Kaufman was the study's lead investigator. "Advanced melanoma remains a complex disease to treat, requiring the use of several modalities over the course of a patient's therapeutic journey. As an oncolytic viral therapy, T-VEC has a unique approach, and provides another option for treating eligible patients with unresectable disease that has recurred after initial surgery," notes Kaufman, who is also a professor of both surgery and medicine at Rutgers Robert Wood Johnson Medical School and the president of the Society for Immunotherapy of Cancer.
"While we may not cure every case of melanoma with these types of immunotherapies, treatments such as T-VEC are enabling us to better manage the disease as if it were a chronic illness like diabetes," adds Kaufman. He notes next steps are to combine T-VEC with a new class of drugs known as 'checkpoint inhibitors' that also produce an immune response in the body by taking the breaks off the immune system and enabling it to fight off cancer. Such study is underway currently at Rutgers Cancer Institute.”