Orion Pharma has reported data from the Phase I segment of its ongoing Phase I/II TEADES trial, assessing ODM-212 in patients with advanced solid tumours.
The open-label, first-in-human, multi-site trial evaluated the tolerability, safety, and preliminary efficacy of the oral pan-Transcriptional Enhanced Associate Domain (TEAD) inhibitor.
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The results showed ODM-212 was well tolerated, with no dose-limiting toxicities and no maximum tolerated dose reached.
In the Phase I segment, the most common treatment-related adverse event (TRAE) was reversible proteinuria, reported in 19.7% of patients and resulting in treatment adjustment in 7.9% of cases.
Other frequently observed adverse events included increased lipase (15.8%) and nausea (10.5%).
Treatment responses, as measured by RECIST 1.1, were seen across multiple doses, with an overall response rate of 15.6%.
Notably, higher response rates were documented in patients with mesothelioma (ORR 27.8%, disease control rate 77.8%) and epithelioid haemangioendothelioma (EHE) (ORR 22.2%, disease control rate 100%).
Orion Pharma research and development executive vice-president professor Outi Vaarala said: “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.”
The Phase II segment of the TEADES trial is ongoing and will enrol up to 300 patients with malignant pleural mesothelioma, EHE, or other solid tumours with Hippo pathway dysfunction who have progressed after standard therapies.
Conducted at centres in Europe and the US, the TEADES trial is assessing the safety, tolerability, overall response rate, progression-free survival, and overall survival.
ODM-212 is an orally administered small-molecule inhibitor developed by Orion Pharma.
