In September 2024, IO Biotech announced “promising” data from its Phase II basket trial of IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab). These results were shared in a conference presentation that included clinical and biomarker data from patients with recurrent or metastatic (advanced) squamous cell carcinoma of the head and neck (SCCHN) with PD-L1 CPS ≥ 20. The study met its primary endpoint and identified a safety profile consistent with prior studies.
IO102-IO103
IO Biotech’s lead product candidate is IO102-IO103, which combines two wholly owned T-win vaccines designed to “activate and expand” T cells specific for IDO and PD-L1. T-win is an immune-modulating vaccine technology that is directed against tumour cells and the “most important” immune-suppressive cells in the tumour microenvironment (TME). Many types of solid tumours and immune-suppressive cells (Tregs and TAms) in the TME overexpress IDO and/or PD-L1. Thus, the combination of the two vaccines is intended to “have a synergistic effect” that leads to “enhanced cell killing”.
The Phase II basket study is a non-comparative, open-label trial that investigates the safety and efficacy of a combination of IO101-IO103 with pembrolizumab as a first-line treatment in up to 60 patients with metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥ 50% and recurrent or metastatic SCCHN with PD-L1 CPS ≥ 20. The primary endpoint is overall response rate (ORR).
Promising data
Data from 18 efficacy evaluable patients revealed:
- The achievement of the primary endpoint – confirmed 44.4% overall response rate (ORR) in a PD-L1 high population of patients with SCCHN irrespective of HPV status.
- An “encouraging” 6.6-month median progression-free survival (PFS).
- A 66.7% disease control rate (DCR).
- A safety profile that is consistent with previously reported data from a combination approach.
- The detection of T-cell responses to both IO102 (targeting IDO) and IO103 (targeting PD-L1) after treatment.
Dr Jonathan Riess, principal investigator of the trial and Director, Thoracic Oncology at UC Davis Comprehensive Cancer Centre, is encouraged by the data in support of the combination approach.
“Given the need for new treatment options that are effective, safe, and accessible for head and neck cancer patients, further investigation of this combination should be conducted to build on the findings of this Phase II trial.”
Chief Medical Officer of IO Biotech, Dr Qasim Ahmad described “accumulating” evidence that the combination could be a “safe and efficacious first-line treatment for patients with a range of cancers”. This includes those with metastatic and “difficult-to-treat disease”.
“Importantly, with mPFS of 6.6 months, more than half of the patients in this trial had over 180 days of progression-free survival. These data are supportive of further investigation of this combination regimen as part of our commitment to transform the lives of cancer patients through our novel therapeutic vaccine.”
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