IO Biotech announced positive results from its Phase 2 basket trial (IOB-022/KN-D38) evaluating IO102-IO103, a therapeutic cancer vaccine candidate, in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for first-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The data, presented at the 2024 ESMO Congress, highlight the potential of this combination for patients with PD-L1 high (CPS ≥ 20) SCCHN, irrespective of HPV status.
The study met its primary endpoint, demonstrating a confirmed overall response rate (ORR) of 44.4% in efficacy-evaluable patients (n=18). Secondary endpoint data showed a median progression-free survival (PFS) of 6.6 months and a disease control rate (DCR) of 66.7%. The combination therapy's safety profile was consistent with previously reported data, showing no added significant systemic toxicity compared to anti-PD-1 monotherapy.
Jonathan Riess, MD, principal investigator of the trial and Director, Thoracic Oncology at the UC Davis Comprehensive Cancer Center, stated, “These encouraging data further support the potential of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with recurrent or metastatic SCCHN including HPV-positive and -negative patients. 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 2 trial.”
About the Study
The Phase 2 basket study (IOB-022/KN-D38; NCT05077709) is an open-label trial designed to assess the safety and efficacy of IO102-IO103 in combination with pembrolizumab as a first-line treatment in 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. The data cutoff for the presented results was August 2, 2024.
IO102-IO103: Mechanism of Action
IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to target and kill both tumor cells and immune-suppressive cells within the tumor microenvironment (TME). It works by stimulating the activation and expansion of T cells against cells expressing indoleamine 2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1).
IO Biotech is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma. Additional Phase 2 basket trials are also underway to investigate the combination in various solid tumors.
