NEW YORK – IO Biotech on Tuesday said it is evaluating its investigational cancer vaccine IO102-IO103 in combination with Merck's anti-PD-1 drug pembrolizumab (Keytruda) in treatment-naive, advanced melanoma patients.
IO102-10103 targets immunosuppressive mechanisms that are modulated by IDO and PD-L1 proteins. In the Phase III trial IO Biotech is sponsoring, researchers will randomize previously untreated patients with unresectable or metastatic melanoma to either the IO102-IO103-pembrolizumab combination or just pembrolizumab. Investigators will also evaluate patients for biomarkers of response.
Under the terms of the collaboration with IO Biotech, Merck will supply pembrolizumab for the Phase III trial. The late-phase study was planned based on the results of a Phase I/II trial, in which IO102-IO103 in combination with an anti-PD-1 monoclonal antibody shrank tumors in 73 percent of 30 metastatic melanoma patients. Based on these data, the US Food and Drug Administration granted the IO102-IO103-pembrolizumab combination breakthrough therapy status as a treatment for advanced melanoma patients.
"Although therapies are available to treat metastatic melanoma, the clinical outcomes for patients with advanced disease remain poor, and novel therapeutic options are desperately needed," Mai-Britt Zocca, CEO and founder of Copenhagen, Denmark-based IO Biotech, said in a statement. "We look forward to expanding our data set on IO102-IO103 with Keytruda combination results, which we believe will support the potential approval of IO102-IO103 as a first-line therapy for melanoma and other difficult-treat-cancers."