Phase 3 Trial of First-Line IO102-IO103/Pembrolizumab to Continue in Advanced Melanoma
Source: OncLive, September 2024
The phase 3 IOB-013/KN-D18 trial (NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab (Keytruda) for the first-line treatment of patients with advanced melanoma will continue without modifications following a recommendation from an independent data monitoring committee (IDMC).
In a review of safety and efficacy data at a per-protocol interim analysis conducted 1 year after 225 patients were randomly assigned, the IDMC reported no new safety signals. Overall response rate (ORR) data did not meet the criteria to declare superiority for IO102-IO103 plus pembrolizumab vs pembrolizumab alone; however, the study sponsor, IO BioTech, noted in a news release that the interim efficacy analysis for ORR included a high statistical bar (P ? .005).
An analysis of progression-free survival (PFS)—the study’s primary end point—will be conducted when 226 disease progression events or deaths are reported, which is projected to occur in the first half of 2025.