IO Biotech Reports Positive Phase 2 Results for IO102-IO103 in Advanced Head and Neck Cancer

IO Biotech, a clinical-stage biopharmaceutical company, has announced encouraging results from its Phase 2 basket trial of IO102-IO103, an investigational therapeutic cancer vaccine. This study examined the efficacy and safety of the vaccine in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with squamous cell carcinoma of the head and neck (SCCHN) who have high levels of PD-L1 (CPS ≥ 20). The data was presented at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona.

The trial involved 18 patients with advanced SCCHN. Key findings included a 44.4% overall response rate (ORR), a median progression-free survival (PFS) of 6.6 months, and a 66.7% disease control rate (DCR). The safety profile was consistent with previous studies, showing no new systemic safety concerns. The combination treatment also induced T-cell responses targeting both IDO and PD-L1.

Dr. Jonathan Riess, the principal investigator of the trial and Director of Thoracic Oncology at UC Davis Comprehensive Cancer Center, expressed optimism about the results, suggesting that IO102-IO103 combined with pembrolizumab could become a first-line treatment for patients with both HPV-positive and HPV-negative SCCHN. He emphasized the need for new effective, safe, and accessible treatment options for head and neck cancer patients.

Dr. Qasim Ahmad, Chief Medical Officer of IO Biotech, highlighted the broader implications of the study, noting that the combination therapy shows potential as a first-line treatment for various cancers, including difficult-to-treat and metastatic diseases. He pointed out that more than half of the patients in the trial experienced over 180 days of progression-free survival, supporting further investigation into this combination regimen.

The Phase 2 basket study (IOB-022/KN-D38) is a non-comparative, open-label trial aimed at assessing the safety and efficacy of IO102-IO103 in combination with pembrolizumab as a first-line treatment for up to 60 patients with metastatic non-small cell lung cancer (NSCLC) and recurrent or metastatic SCCHN with high PD-L1 levels. Patients were considered efficacy evaluable if they had at least two post-baseline tumor assessments or discontinued after two cycles of treatment by the data cut-off of August 2, 2024.

To date, the safety profile observed in this study aligns with previous findings involving IO102-IO103 in combination with checkpoint inhibitors, with the most common adverse events being low-grade, transient injection site reactions. Enrollment for all cohorts in this trial has been completed, and data from the NSCLC cohort will be presented at a future medical meeting.

IO Biotech’s investigational cancer vaccine, IO102-IO103, is designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment by activating and expanding T cells against IDO and PD-L1 positive cells. The company is also conducting a Phase 3 trial (IOB-013/KN-D18) for advanced melanoma and another Phase 2 basket trial (IOB-032/PN-E40) for neo-adjuvant/adjuvant treatment of solid tumors.

These clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which supplies pembrolizumab. IO Biotech retains global commercial rights to IO102-IO103 and is headquartered in Copenhagen, Denmark, with U.S. headquarters in New York, New York.

In summary, the promising results from IO Biotech’s Phase 2 trial of IO102-IO103 in combination with pembrolizumab provide a strong rationale for further investigation of this therapeutic approach in treating various cancers, including SCCHN and NSCLC.