- Trial expected to reach the primary endpoint of progression free survival in the second half of 2025
- Per-protocol interim analysis expected in mid-2024
“The Phase 1/2 data of IO102-IO103 in combination with a PD-1 inhibitor in patients with first-line advanced melanoma demonstrated approximately double the effect than would have been expected with PD-1 inhibitor monotherapy in this patient population – with 80% of patients achieving a response, 50% of patients achieving a complete response, and no additional systemic toxicity than that typically seen with a PD-1 inhibitor alone,” said
“Metastatic melanoma is a life-threatening cancer and although many new treatments have been introduced over the last decade that have significantly improved the outcomes for patients, there still remains a high unmet need for more efficacious options with low treatment-induced toxicity for people battling advanced melanoma,” said
About Trial Endpoints
The primary endpoint of the IOB-013/KN-D18 trial is progression free survival (PFS). The PFS analysis is event-driven and will be conducted when 226 events have occurred in the trial, which the company estimates will take place in the second half of 2025. Additionally, there is a planned per-protocol interim analysis of overall response rate when the first 225 randomized patients reach one year of treatment in mid-2024. The outcome of this analysis is expected in the third quarter of 2024. There is a high statistical bar for the Phase 3 interim analysis (p≤0.005), which was set to preserve most of the alpha for the primary endpoint of PFS. Regardless of the outcome of the interim analysis, the trial is designed to continue to the primary PFS endpoint.
About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial
IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma, being conducted in collaboration with Merck. Patients have been enrolled from centers across
About IO102-IO103
IO102-IO103 is an investigational immune-modulating therapeutic cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1). The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced non-small cell lung cancer and head and neck cancer (SCCHN), and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) evaluating IO102-IO103 plus pembrolizumab as a perioperative treatment in solid tumors including melanoma and SCCHN.
The clinical trials are sponsored by
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Forward-Looking Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing of the interim analysis of our Phase 3 trial, current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law,
Company Contact:
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