Exhibit 99.1
IO Biotech Updates on Pivotal Phase 3 Trial of IO102-IO103 in
Combination with KEYTRUDA® (pembrolizumab) as a First-Line
Treatment for Patients with Advanced Melanoma
- Based on a per-protocol interim analysis of safety and efficacy data, the Independent Data
Monitoring Committee (IDMC) recommended that the trial continue without modifications
- No new safety signals observed at interim analysis
- Primary endpoint of progression free survival projected to be reached in the first half of 2025
New York, NY August 30, 2024: IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel,
off-the-shelf, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today announced that an Independent Data Monitoring Committee
(IDMC) recommended continuation of the companys pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) of its lead investigational therapeutic vaccine, IO102-IO103,
following a per-protocol interim analysis. The trial is evaluating IO102-IO103 in combination with KEYTRUDA® (pembrolizumab), Mercks anti-PD-1 therapy, as a first-line treatment for patients with unresectable or metastatic (advanced) melanoma. Based on their review of the safety and efficacy data, the IDMC
recommended that the trial continue without modifications and noted that no new safety signals were observed. The primary endpoint of progression-free survival (PFS) is projected to be reached in the first half of 2025.
The per-protocol interim analysis was performed one year after 225 patients were randomized in the trial. The interim
efficacy analysis was intentionally set with a high statistical bar (p≤0.005), and based on the analysis, the IDMC determined that the data did not meet the criteria to declare superiority of ORR. The trial was designed to preserve most of the
statistical alpha for the trials primary endpoint of PFS. The PFS analysis is event-driven and will be conducted when 226 events (disease progression or death) have been reported in the trial with independent central review. With 407 patients
randomized, the trial is powered at 89% to detect a 35% reduction in the risk of an event.
To date, none of the approved immunotherapeutic
combinations for the treatment of advanced melanoma demonstrated statistical significance in ORR in large Phase 3 trials; nevertheless, these trials achieved statistical significance on PFS, said
Mai-Britt Zocca, PhD, President and CEO of IO Biotech. Based on the 25.5 months median PFS we observed in the Phase 1/2 trial of IO102-IO103 in combination with a
PD-1 inhibitor in advanced melanoma, with no added significant systemic toxicity than that typically seen with anti-PD-1
monotherapy, we remain optimistic about meeting the primary endpoint of PFS, projected to occur in the first half of 2025.
Igor Puzanov, MD, MSCI,
FACP, Director, Center for Early Phase Clinical Trials, Chief, Division of Melanoma, Department of Medicine and Investigator for the Phase 3 Study at Roswell Park Comprehensive Cancer Center, Buffalo, New York commented, The incidence of
melanoma is on the rise and new treatments are needed. This is a novel investigational immune-modulatory therapeutic cancer vaccine combined with an anti-PD-1 therapy
that has the