Orion Pharma’s Phase I data from the TEADES trial show that ODM-212, an oral pan‑TEAD inhibitor, is generally well tolerated with no dose‑limiting toxicities and no maximum tolerated dose reached. Reversible proteinuria was the most common treatment‑related adverse event (19.7%). The overall response rate across Phase I was 15.6%, with higher activity in mesothelioma (ORR 27.8%, DCR 77.8%) and EHE (ORR 22.2%, DCR 100%). The Phase II portion will enrol up to 300 patients to further evaluate efficacy and safety in Hippo pathway–dysfunctional tumours.
Orion Pharma Reports Promising Phase I TEADES Results for ODM-212 in Advanced Solid Tumours
The most common TRAE was reversible proteinuria
Orion Pharma has released Phase I data from the ongoing Phase I/II TEADES trial evaluating ODM-212, an oral pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor, in patients with advanced solid tumours.
Trial Design and Objectives
The open-label, first-in-human, multicentre Phase I portion assessed safety, tolerability and early signs of anti-tumour activity across multiple dose levels. The ongoing Phase II stage will further evaluate efficacy in selected tumour types with Hippo pathway dysfunction.
Safety Profile
ODM-212 was generally well tolerated in the Phase I cohort:
- No dose-limiting toxicities (DLTs) were reported and a maximum tolerated dose (MTD) was not reached.
- The most common treatment-related adverse event (TRAE) was reversible proteinuria, occurring in 19.7% of patients and prompting dose modification in 7.9%.
- Other frequently observed TRAEs included elevated lipase (15.8%) and nausea (10.5%).
Early Efficacy Signals
Tumour responses assessed by RECIST 1.1 were seen at several dose levels, producing an overall response rate (ORR) of 15.6% in the Phase I population. Activity was notably higher in certain tumour types:
- Mesothelioma: ORR 27.8%; disease control rate (DCR) 77.8%.
- Epithelioid Haemangioendothelioma (EHE): ORR 22.2%; DCR 100%.
“We are encouraged by the safety profile and early signs of clinical activity observed with ODM-212, particularly in mesothelioma and EHE, where treatment options remain limited. These results support continued clinical development of ODM-212 both as a monotherapy and in combination settings.” — Professor Outi Vaarala, Executive Vice‑President, Research and Development, Orion Pharma
Next Steps
The Phase II segment of TEADES is ongoing and is planned to enrol up to 300 patients with malignant pleural mesothelioma, EHE or other solid tumours demonstrating Hippo pathway dysfunction after progression on standard therapies. The trial — conducted at sites across Europe and the United States — will continue to assess safety, tolerability, ORR, progression-free survival (PFS) and overall survival (OS).
About ODM-212: ODM-212 is an orally administered, small-molecule inhibitor targeting TEAD transcription factors, developed by Orion Pharma to disrupt oncogenic signalling driven by Hippo pathway dysregulation.
Original reporting by Clinical Trials Arena (a GlobalData brand). This summary is provided for informational purposes only and should not be taken as medical advice; consult healthcare professionals for clinical decisions.
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