Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 20

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 20
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C portion of the trial we are investigating Cylembio® in patients expressing PD-L1 ≥50%, a patient population similar to Cohort A in our Phase 1/2 trial of IO102 in combination with pembrolizumab as first line treatment for patients with metastatic NSCLC. Study protocol-specified pembrolizumab monotherapy benchmarks for the primary endpoint of ORR are Keynote-042 study (39%) for the NSCLC cohort A and Keynote-048 study (23%) for the SCCHN cohort B. 

Our IOB-022 trial is a non-comparative, open label, unblinded trial and investigates the safety and efficacy of Cylembio in combination with pembrolizumab, intended to investigate each of the following metastatic first-line indications: 

•NSCLC with PD-L1 TPS ≥50% 

•SCCHN (HPV +/-) with PD-L1 CPS ≥20 

The primary endpoint of the Phase 2 trial is ORR, with secondary endpoints of PFS according to RECIST 1.1, DoR, DCR, OS and safety reporting.

We initiated the IOB-022/KN-D38 trial in April 2022 and closed enrollment in June 2024 with 37 patients enrolled in cohort A and 21 patients enrolled in cohort B. The study enrolled patients in three countries (the United States, Spain and the United Kingdom) at 22 sites. 

As presented at ESMO in September 2024, results from the IOB-022/KN-D38 Phase 1/2 study of Cylembio in combination with pembrolizumab in recurrent and/or metastatic SCCHN met its primary end point of ORR. Of the 21 patients enrolled in cohort B, 18 were efficacy evaluable and met the primary endpoint for this cohort with a confirmed ORR of 44.4%. Among the secondary endpoints, the data showed an encouraging 6.6-month median PFS, and a 66.7% DCR. 

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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 first line metastatic NSCLC were encouraging. Of the 37 patients enrolled in cohort A, 31 were efficacy evaluable and the data demonstrated promising activity with a