Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 28

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 28
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 patient had symptoms of myocarditis at time of death with highly elevated troponin I. Bedside echocardiography showed an ejection fraction of 15%, which at baseline was 60%. The myocarditis was never confirmed pathologically. All the AEs leading to treatment discontinuation were considered by the investigator to be related to nivolumab. The rate of treatment-related adverse events leading to discontinuation of both nivolumab and Cylembio® was 17%. 

Response Rate in Cohort A 

Results from the MM1636 trial, with a cut-off date of January 5, 2023, showed an ORR of 80% (95% CI; 62.7-90.5%). Two of the 24 responding patients progressed before subsequent radiological confirmation, therefore the confirmed ORR was 73.3% (95% CI; 54.1% to 87.7%). The CRR was 50.0% (95% CI; 31.3% to 68.7%). 

Table 3: Objective Response Rate by Investigator Review 

    Date of data cut-off:
     
    January 5, 2023

    Median follow-up
     
    45.3 months

    Evaluable patients

    30

    Responders (including unconfirmed responses)
     
    80.0% (N = 24)

    Confirmed responders

    22

    Best Overall (confirmed) Response Rate (Clopper Pearson Exact 95% CI)
     
    73.3% (N=22/30) 54.1% to 87.7%

    Complete Response Rate (Clopper Pearson Exact 95% CI)
     
    50.0% (N=15/30) 31.3% to 68.7%

    Partial Response Rate (Clopper Pearson Exact 95% CI)
     
    23.3% (N=7/30) 9.9% to 42.3%

    Best overall (confirmed) response rate by PD-L1 status (PD-L1<1% vs 1%)

    PD-L1 positive patients (Clopper Pearson Exact 95% CI)
     
    88.2% (N=15/17) 63.6% to 98.5%

    PD-L1 negative patients (Clopper Pearson Exact 95% CI)