Intralesional injection of an oncolytic therapy significantly increased the durable response rate in advanced melanoma compared with a control therapy, according to results of a randomized trial.
Patients treated with the virus-derived talimogene laherparepvec (T-VEC) had a 16.3% rate of durable responses, defined as partial or complete response maintained for at least 6 months. That compared with 2% of patients treated with granulocyte-macrophage colony-stimulating factor (GM-CSF) who had durable responses.
Subgroup analysis showed durable responses in 33% of patients with IIIB-C (nonvisceral) disease and in 24% of patients who received T-VEC as first-line therapy, Howard L. Kaufman, MD, of Rush University Medical Center in Chicago, reported at the American Society of Clinical Oncology meeting.
“T-VEC is the first oncolytic immunotherapy to demonstrate therapeutic benefit against melanoma in a phase III trial,” said Kaufman. “The only grade 3/4 adverse event that occurred in more than 2% of patients was cellulitis. We observed a trend toward improved overall survival with T-VEC at interim analysis.”
Despite recent advances in the treatment of melanoma, patients with stage IIIB/C disease have a 5-year disease-free survival of 30% to 35%. Survival in stage IV melanoma is less than 15%.
Immunotherapeutic agents, such as interleukin-2 and ipilimumab (Yervoy), have demonstrated efficacy in metastatic melanoma, providing a rationale for continued investigation of immunology-based treatment strategies.
T-VEC consists of an attenuated herpes simplex virus, resulting from deletion of the viral neurovirulence gene and replacement of ICP47 with the human GM-CSF gene, said Kaufman. After direct injection into a melanoma lesion, T-VEC causes lysis of tumor cells and induces local and systemic immune responses that are enhanced by expression of GM-CSF.
Kaufman reported results from a trial involving 436 patients with unresectable stage IIIB/C and IV melanoma. Investigators at 64 sites in four
Read the rest of this article on MedPage Today: ASCO: Herpes-Derived Tx for Melanoma?
