IO Biotech announces achievement of Phase 3 trial recruitment milestone

IO Biotech announced that it has randomized 225 patients in its global Phase 3 clinical trial for IO102-IO103, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with advanced melanoma. This clinical milestone is significant as the Phase 3 trial protocol calls for an interim analysis of overall response rate one year after 225 patients have been enrolled. Data obtained from this interim analysis, if positive, could allow for submission of a Biologics License Application for an accelerated approval in the United States. Additionally, the company announced that it is increasing the number of patients to be enrolled in the Phase 3 trial to 380 patients, which could potentially accelerate the time to reach the primary end point of progression free survival. If the data are supportive, the PFS endpoint would serve as the basis for submitting marketing applications on a global basis. Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech said, “With the momentum of enrollment building in this trial, we are taking the opportunity to increase the target for full enrollment by 80 patients, which will potentially accelerate the timeline to the primary endpoint of PFS. Even with this increase in target enrollment to 380 patients, we continue to expect to reach full enrollment in this trial by the end of this year and we continue to expect our cash to support our activities through the third quarter of 2024.”