Company: IOBT
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001193125-25-281820
Chunk: 6

Company: IO Biotech, Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Item 2
Chunk 6
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 The primary endpoint was PFS as assessed by a blinded independent review committee per RECIST v1.1. The early and sustained separation of PFS curves demonstrated an improvement with a hazard ratio of 0.77 [95% CI: 0.58-1.00; p=0.056; threshold for significance p≤0.045]. Based on an intent-to-treat analysis, patients in the study treated with Cylembio in combination with pembrolizumab achieved 19.4 months of median progression free survival compared to 11.0 months in patients treated with pembrolizumab alone. Although overall survival is not yet mature, a trend favoring the combination arm was observed [HR 0.79 (95% CI: 0.57-1.10)]; the Company projects OS results to be available in 2026. 

The Company is supporting an investigator-initiated study (“IIT”) (NCT05912244) evaluating the combination of Cylembio plus nivolumab-relatlimab for the first-line treatment of patients with unresectable advanced melanoma at three study sites in the United States. The IIT has completed enrollment with 43 patients. Preliminary analysis of data as of September 2025 for 32 patients, with median follow up not yet mature, showed an early trend suggestive of improved clinical activity for patients treated with the combination of Cylembio plus nivolumab-relatlimab as compared to historic data for patients treated with nivolumab-relatlimab alone. Importantly, no additional systemic toxicity was observed in the IIT in patients treated with the combination of Cylembio plus nivolumab-relatlimab. No head-to-head trials of Cylembio plus nivolumab-relatlimab versus nivolumab-relatlimab have been conducted and cross clinical trial comparisons should be interpreted with caution. 

On September 29, 2025, the Company issued a press release announcing that the FDA has recommended that the Company not