Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 24

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 24
---
ogene BRAF and MAPK pathway. According to Drummer (Lancet 2018), around 35-50% of advanced melanoma patients have a targetable BRAF mutation, and in approximately 90% of these cases, the mutation consists of valine substituted with glutamic acid at amino acid 600 (“BRAF V600”). 

Recommended first-line treatment options for the treatment of unresectable or metastatic melanoma and for patients with or without BRAF-mutant advanced melanoma are summarized below: 

•Anti-PD-1 monotherapy (nivolumab or pembrolizumab); 

•Anti-CTLA-4 (ipilimumab) and anti-PD-1 (nivolumab) combination therapy; 

•Anti PD-1 (nivolumab) and LAG-3 (relatlimab) combination therapy;

•Dabrafenib/trametinib combination targeted therapy if the activating BRAF-V600 mutation is present; and 

•Vemurafenib/cobimetinib + atezolizumab combination targeted therapy and immunotherapy if the activating BRAF-V600 mutation is present. 

21

Table 1a: Certain Currently Approved Immunotherapies and Targeted Agents

    ORR:
    Overall response rate

    CRR:
    Complete response rate

    PFS:
    Progression free survival

    OS:
    Overall survival

    mDoR
    Median duration of response

    mo:
    months

    y:
    years

    NR
    Not reached

    N/A:
    Not available 

    TRAE:
    Treatment-related adverse events

Table 1b: Selected Phase 3 Trial Update - American Society of Clinical Oncology (“ASCO”) 2023 

22

For patients with tumors harboring a BRAF V600 mutation, treatment choices are between MAPK or checkpoint inhibitor therapy. Cross trial comparisons indicate that combined MAPK or BRAF plus MAPK kinase (“MEK”) has proven to have higher response rates than checkpoint inhibitor therapies. Data from cross trial comparisons suggest that the responses to checkpoint inhibitor therapies are slower in onset but more durable. For patients who are candidates for both treatments, standard of care guidelines recommend that checkpoint inhibitor therapies should be chosen as first-line therapy. Patients whose tumors are not progressing quickly and are not immediately threatening an important organ function, should be considered for checkpoint inhibitor therapies first, preserving MAPK for subsequent lines.