Orion Pharma announces first results from Phase 1/2 TEADES trial with TEAD inhibitor ODM-212 in patients with advanced solid tumours

• Data presented at 2026 ASCO® Annual Meeting show ODM-212 was well tolerated, with proteinuria being the most common treatment related adverse event (TRAE)
• ODM-212 showed early efficacy in Hippo pathway dysregulated tumours, such as mesothelioma and EHE (epithelioid hemangioendothelioma)
• A clinical development program is underway investigating ODM-212 as a monotherapy and in combination with standard of care treatments in various solid tumours

Orion Pharma  announced first Phase 1 results from the ongoing Phase 1/2 multi-site, open-label, first-in-human TEADES trial evaluating the safety, tolerability and preliminary efficacy of ODM-212, a small molecule oral pan-TEAD inhibitor in patients with advanced solid tumours. According to the results, ODM-212 was well tolerated. Dose limiting toxicities (DLT) were not reported and the maximum tolerated dose (MTD) was not reached. The most frequent treatment-related adverse event (TRAE) was proteinuria (19.7%), which was reversible and resulted in treatment adjustment in 7.9% of patients. Other common TRAE’s were increased lipase (15.8%) and nausea (10.5%).

Treatment responses by RECIST 1.1 were observed across multiple doses (overall response rate¹, ORR 15.6%), predominantly in patients with mesothelioma (ORR 27.8%, disease control rate², DCR 77.8%) and EHE (ORR 22.2%, DCR 100%). The new data were presented during the 2026 American Society of Clinical Oncology Annual Meeting, taking place in Chicago, IL, United States, from May 29-June 2, 2026. 

“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”, said Professor Outi Vaarala, Executive Vice President, Research & Development at Orion Pharma. “These results support continued clinical development of ODM-212 both as a monotherapy and in combination settings.”

Phase 2 of the TEADES trial is ongoing. The trial will enroll up to 300 patients with malignant pleural mesothelioma (MPM), EHE or other solid tumours with dysfunction in Hippo pathway, and who have progressed despite available standard treatments and with limited further treatment options. Another ongoing Phase 1/2 trial TEADCO is evaluating ODM-212 in combination with standard of care treatments in advanced mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer.