KENILWORTH (NJ) (dpa-AFX) - IO Biotech (IOBT) announced that the Independent Data Monitoring Committee found the data from the Pivotal Phase 3 Trial of IO102-IO103 in combination with KEYTRUDA (pembrolizumab) as a first-line treatment for advanced melanoma did not meet the criteria for declaring superiority in overall response rate or ORR.
However, the Independent Data Monitoring Committee or IDMC recommended continuation of the company's pivotal Phase 3 trial 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), Merck's 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.
IOBT closed Friday's regular trading at $1.50 down $0.04 or 2.60%. In the after-hours trading, the stock further dropped $0.19 or 12.67%.
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