Talimogene laherparepvec (T-VEC), an oncolytic virus, in conjunction with ipilimumab, an immune checkpoint inhibitor, may be more beneficial than either agent alone, and the combination appears to have a tolerable safety profile, a study published in the Journal of Clinical Oncology suggests.1
For the open-label, multicenter, phase 1b trial, investigators enrolled 19 treatment-naïve patients with unresectable stage IIIB-IV melanoma. All participants received T-VEC 106 plaque-forming units/mL intratumorally in week 1, then in week 4 and every 2 weeks thereafter at a dose of 108 plaque-forming units/mL. Beginning at week 6, patients received ipilimumab 3 mg/kg intravenously every 3 weeks for 4 infusions.
Results showed that at a median follow-up of 20.0 months, the objective response rate was 50%, and 44% of patients had a durable response lasting at least 6 months. Researchers found that the 18-month progression-free survival rate was 50% and the 18-month overall survival rate was 67%.
No dose-limiting toxicities were observed, and no new safety signals were detected for either agent.
A total of 26.3% of patients reported experiencing grade 3 to 4 treatment-related adverse events; 15.8% had adverse events attributable to T-VEC, and 21.1% had adverse events related to ipilimumab.
1. Puzanov I, Milhem MM, Minor D, Hamid O, Li A, Chen L, et al. Talimogene laherparepvec in combination with ipilimumab in previously untreated, unresectable stage IIIB-IV melanoma [published online ahead of print June 13, 2016]. J Clin Oncol. doi: 10.1200/JCO.2016.67.1529.