IO Biotech (IOBT) has announced that the Independent Data Monitoring Committee (IDMC) has reviewed the data from its pivotal Phase 3 trial of the combination therapy IO102-IO103 and KEYTRUDA (pembrolizumab) for first-line treatment of advanced melanoma. The findings indicated that the therapy did not meet the criteria for superiority in overall response rate (ORR).
Despite this, the IDMC has recommended the continuation of the trial following a per-protocol interim analysis. This trial is assessing the efficacy of IO102-IO103 in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in treating patients with unresectable or metastatic melanoma.
The committee's review of the safety and efficacy data suggested that the trial should proceed without any modifications, and no new safety concerns were reported. The primary endpoint, progression-free survival (PFS), is expected to be achieved in the first half of 2025.
This interim analysis was conducted one year after the randomization of 225 patients in the trial.
On the stock market, IOBT closed at $1.50 on Friday, down $0.04 or 2.60%. In after-hours trading, the stock further declined by $0.19 or 12.67%.
