Igor Puzanov, MD, MSCI, FACP
In 2015, talimogene laherparepvec (T-VEC; Imlygic) became the first in-class oncolytic immunotherapy to be FDA approved for the treatment of advanced-stage unresectable melanoma, but its path forward may be in combination with checkpoint inhibitors, explained Igor Puzanov, MD, MSCI, FACP.
, Puzanov, director of the Early Phase Clinical Trials Program, chief of Melanoma, co-leader, CCSG Experimental Therapeutics Program, professor of oncology, Department of Medicine, Roswell Park Comprehensive Cancer Center, discussed the current and potential future utility of T-VEC in patients with advanced-stage melanoma.
OncLive®: What is T-VEC and how does it differ from other immunotherapies?
: T-VEC is a drug dear to my heart; I helped develop it since 2009. T-VEC is an oncolytic virus. The basis of T-VEC is the herpes simplex virus, which is a virus that everybody is exposed to. The researchers modified it, so it cannot infect healthy cells; it can only infect the tumor cells of not just melanoma, but other [malignant cells].
We now have phase III trials for never-treated patients, regardless of BRAF mutation, so anybody can receive an injectable by itself—a CT scan- or ultrasound-guided injection. Half of patients will get pembrolizumab, which is the standard of care, and half of them will get pembrolizumab and T-VEC. We should have some results by spring 2019.
Which patients are eligible for T-VEC?
For single-agent T-VEC, patient selection is clear based on the label, which indicates unresectable stage IIIb, IIIc, and IVa melanoma. Let’s say a patient comes in with [involved] lymph nodes—in transit or satellite metastases. You know you can cut them out, but you will leave a patient very debilitated. They’ll have a lot of defects, and will be potentially missing muscle, fat, or other things that will make your patient’s life miserable.
The data from the phase III OPTiM trial showed that you can have 11% of patients with complete disappearance of their tumors if you inject their tumors. You don't have to inject all of them because the other tumors may die by approximation. Another 15% will have shrinkage and stabilization, so we use it for a lot for elderly patients where you worry about the side effects of systemically delivered immunotherapies, such as pembrolizumab or nivolumab.
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