Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 34

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 34
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 the ORR for patients with previously untreated metastatic NSCLC and a PD-L1 expression of 50% or higher who were treated with pembrolizumab monotherapy was 39% and pembrolizumab in combination with chemotherapy 61%. In high PD-L1, approximately 40% of patients are alive after 30 months on pembrolizumab monotherapy. In low PD-L1, approximately 45% of patients are alive at 24 months on pembrolizumab plus chemotherapy.

We have initiated development of Cylembio plus anti PD-1 in first-line treatment of metastatic solid tumors with high PD-L1 expression. NSCLC is one of the indications in our IOB-022/KN-D38 basket trial. As presented at SITC in November 2024, preliminary results from the IOB-022/KN-D38 Phase 1/2 study of Cylembio in combination with pembrolizumab in metastatic NSCLC demonstrated promising activity. Of the 37 patients enrolled in cohort A, 31 were efficacy evaluable with 55% unconfirmed ORR/48% confirmed ORR in efficacy evaluable patients, an encouraging 8.1-month median PFS, no disease progression at 12 months in approximately half of the patients, and an 81% DCR. DOR has not yet matured at this data cut off period.

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Figure 16: IOB-022/KN-D38 NSCLC (Cohort A) - PFS and Confirmed OR

In both cohorts, the safety profile was consistent with previously reported data when combined with anti-PD-1 monotherapy, including no additional significant systemic toxicity compared to anti-PD-1 monotherapy. 

Squamous Cell Carcinoma of the Head and Neck Cancer (SCCHN) 

SCCHN includes cancers of the oral cavity, oropharynx, hypopharynx and larynx, and is the sixth most diagnosed cancer worldwide. According to the International Agency for Research on Cancer of the World Health Organization, it was estimated that 771,000 patients were diagnosed with, and about 385,000 people would die from, SCCHN worldwide. According to the organization, the five-year survival rate for patients suffering from SCCHN was estimated to be 50%. Globally, the SCCHN market generated $3.5 billion in revenue in 2023, and is expected to grow