IO Biotech has completed enrollment in its Phase 2 basket trial, IOB-032/PN-E40, ahead of schedule. The trial evaluates the company’s lead cancer vaccine candidate, IO102-IO103, combined with Merck’s Keytruda (pembrolizumab), in patients with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN). Initial data from this trial is anticipated in 2025.
This early enrollment completion allows IO Biotech to expedite the investigation of its cancer vaccine in earlier stages of disease. It builds upon encouraging clinical activity observed in earlier-stage trials in advanced melanoma, lung cancer, and head and neck cancer, where the vaccine showed promise with minimal systemic toxicity. Coupled with anticipated Phase 3 data for advanced melanoma also expected in 2025, the Phase 2 data could potentially broaden the applicability of this combination therapy across various difficult-to-treat cancers.
The IOB-032/PN-E40 trial enrolled 93 patients across the US, Europe, and Australia. The trial aims to assess the anti-tumor activity, safety, and gather biomarker data for IO102-IO103 with pembrolizumab as a neoadjuvant and adjuvant treatment. The primary endpoint is major pathological response, measured by the reduction of viable tumor cells after treatment. Secondary endpoints include pathological complete response, overall response rate, disease-free survival, event-free survival, and safety. The trial consists of three cohorts, encompassing both single-arm and randomized groups evaluating the combination therapy compared to pembrolizumab alone.
The completion of this trial enrollment positions IO Biotech to potentially expand the clinical utility of its cancer vaccine. The forthcoming data in 2025 will be crucial for understanding the efficacy of IO102-IO103 in earlier stages of cancer, possibly establishing it as a valuable treatment option in the perioperative setting. This could significantly impact patient outcomes, potentially reducing recurrence rates and improving long-term survival for those with resectable melanoma and SCCHN.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
