Orion Pharma has released data from the first phase of its ongoing TEADES clinical trial (Phase I/II), which is evaluating the efficacy of ODM-212 in patients with advanced solid tumors.
An open-label, multicenter human study assessed the tolerability, safety, and preliminary efficacy of an oral pan-transcription-enhanced-associated domain (TEAD) inhibitor.
Results showed that ODM-212 was well tolerated, no dose-limiting toxicities were observed, and the maximum tolerated dose was not reached.
In the first phase of the study, the most common treatment-related adverse event (TRAE) was reversible proteinuria, reported in 19.7% patients and leading to treatment adjustments in 7.9% cases.
Other commonly observed side effects included increased lipase (15,8%) and nausea (10,5%).
Treatment efficacy, as assessed by RECIST 1.1 criteria, was observed across multiple doses, with an overall response rate of 15.6%.
Notably, higher response rates were observed in patients with mesothelioma (overall response rate 27.8%, disease control rate 77.8%) and epithelioid hemangioendothelioma (EHE) (overall response rate 22.2%, disease control rate 100%).
Professor Outi Vaarala, Executive Vice President of Research and Development at Orion Pharma, stated: «We are encouraged by the safety profile and early signs of clinical activity observed with ODM-212, particularly in mesothelioma and epithelial hemangioma, where treatment options remain limited. These results support further clinical development of ODM-212, both as a monotherapy and in combination.».
The Phase 2 TEADES study is ongoing and plans to enroll up to 300 patients with malignant pleural mesothelioma, epithelial hemangioma, or other solid tumors with Hippo pathway dysfunction who have experienced disease progression after standard therapy.
The TEADES study, conducted at centres in Europe and the United States, is assessing safety, tolerability, overall response rate, progression-free survival and overall survival.
ODM-212 is an orally administered small molecule inhibitor developed by Orion Pharma.
The article "Orion Pharma Reports Phase I Clinical Trial Results for TEADES in Solid Tumors" was originally created and published by Clinical Trials Arena, a brand owned by GlobalData.
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