IO Biotech, Inc. announced encouraging preliminary data from the company?s Phase 2 basket trial of IO102-IO103 in combination with Merck?s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) (IOB-022/KN-D38) at the ESMO Congress being held in Madrid from October 20-24, 2023. Jonathan Riess, MD, lead investigator of the trial at the UC Davis Comprehensive Cancer Center, shared encouraging clinical and biomarker data from patients with metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS = 50% and recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) with PD-L1 CPS = 20. As of the data cut off for this poster presentation, 10 out of 18 evaluable NSCLC patients (56%) had achieved a partial response as their best overall response and 3 out of 6 evaluable SCCHN patients had achieved partial response as their best overall response.

The Phase 2 basket study (IOB-022/KN-D38; NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab as a first-line treatment in up to 60 patients with metastatic NSCLC with PD-L1 TPS = 50% or recurrent and/or metastatic SCCHN with PD-L1 CPS = 20. The primary endpoint of the study is overall response rate. Patients enrolled in the study who had at least 2 post-baseline tumor assessments or who discontinued after 2 cycles of study treatment as of the data cut off of August 21, 2023 were considered efficacy evaluable and were included in the ESMO poster presentation.

To date, the safety profile observed in this study is consistent with prior studies of IO102-IO103 in combination with checkpoint inhibitors, with no noted additional significant systemic toxicity, with low grade injection site reactions being the most common treatment related adverse event reported?. The trial is ongoing and continuing to enroll patients in both cohorts. The Phase 2 basket study (IOB-022/KN-D38; NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab as a first-line treatment in up to 60 patients with metastatic NSCLC with PD-L1 TPS = 50% or recurrent and/or metastatic SCCHN with PD-L1 CPS = 20.

The primary endpoint of the study is overall response rate. Patients enrolled in the study who had at least 2 post-baseline tumor assessments or who discontinued after 2 cycles of study treatment as of the data cut off of August 21, 2023 were considered efficacy evaluable and were included in the ESMO poster presentation. To date, the safety profile observed in this study is consistent with prior studies of IO102-IO103 in combination with checkpoint inhibitors, with no noted additional significant systemic toxicity, with low grade injection site reactions being the most common treatment related adverse event reported?.

The trial is ongoing and continuing to enroll patients in both cohorts. Poster title: A Phase 2 trial of the IO102-IO103 vaccine plus pembrolizumab: preliminary analysis for first line (1L) treatment of Non-Small Cell Lung Cancer (NSCLC) and Squamous Cell Carcinoma of the Head and Neck (SCCHN); Poster presentation number: 1038P; Poster first author: Jonathan W. Riess, MD; Onsite poster display date: Monday, October 23, 2023, 9:00 AM ? 5:00 PM CET.