IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win technology platform, has announced data from a pre-defined interim analysis related to the lung cohort of the Phase II basket trial (IOB-022/KN-D38) with IO102-IO103 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy as first-line therapy.
These data were presented at the IASLC 2023 World Conference on Lung Cancer (WCLC). Jonathan Riess, lead investigator of the trial at the UC Davis Comprehensive Cancer Center, presented encouraging early clinical and biomarker data supporting the combination treatment for patients with metastatic non-small cell lung cancer (NSCLC).
Dr Riess commented: “We are encouraged that the clinical activity and safety profile continue to validate the potential of IO102-IO103 in combination with pembrolizumab to treat patients with metastatic NSCLC and PD-L1 TPS ≥50%. Available biomarker results for some patients show vaccine-specific T cell expansion and complete clearance or considerable drop of ctDNA, indicating activity of the treatment after just 21 days. With this interim analysis, where more than half of the evaluable patients had a partial response (8/15 patients or 53.3%), we are optimistic about the development of this potential therapy to help serve the unmet clinical need for improved treatment options for patients with advanced NSCLC.”
Phase II trial of IO102-IO103 vaccine plus pembrolizumab
This ongoing Phase II trial is enrolling patients with metastatic adenocarcinoma NSCLC with a PD-L1 tumour proportion score (TPS) ≥50% and no prior treatments for metastatic disease. Previously published data of the combination of IO102-IO103 and nivolumab in anti-PD1 naïve metastatic melanoma showed robust clinical activity with an overall response rate (ORR) of 80% and a complete response rate (CRR) of 50% reached without additional systemic toxicities. The preliminary analysis in this trial suggests that the combination of IO102-IO103 with pembrolizumab as first-line therapy in patients with metastatic adenocarcinoma of the lung and PD-L1 TPS > 50% is tolerable with encouraging clinical activity.
As of the data cut-off in July 2023, 25 patients had been enrolled in the lung cohort of this basket trial. Included in the company’s mini-oral presentation at IASLC 2023 is data from the pre-defined interim analysis of the first 15 efficacy-evaluable patients who had received at least two full cycles of treatment, and either had at least two post-baseline tumour assessments or discontinued.
The data show that eight of these 15 patients (53.3%), had a confirmed partial response (PR). The median duration of exposure is 15 weeks. The safety profile observed in this study are similar to past studies of IO102-IO103 in combination with pembrolizumab, which have demonstrated a profile consistent with pembrolizumab monotherapy with no noted additional significant systemic toxicity.
Qasim Ahmad, Chief Medical Officer of IO Biotech, added: “We believe our cancer vaccine in combination with an anti-PD-1 antibody could change the treatment paradigm for multiple tumour types and this encouraging initial data show its potential as an efficacious and well-tolerated first-line treatment option for patients with NSCLC. We continue to enroll patients in the NSCLC cohort and the squamous cell carcinoma of the head and neck (SCCHN) cohort of this basket trial, and we look forward to reporting additional clinical and biomarker data over the next several months.”
IO102-IO103 is an investigational immune-modulating cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1. The company is currently conducting a Phase III trial evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients, and a Phase II basket trial evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced non-small lung cancer and head and neck cancer.
IOB-022/KN-D38 is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in patients with either non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). The clinical trial is sponsored by IO Biotech and conducted in collaboration with Merck.