Indication:
Metastatic hormone-sensitive prostate cancer (mHSPC)
Status:
The Phase III study ARANOTE (2021-2024) met primary endpoint LINK TO NEWS. The study evaluates darolutamide in combination with hormonal therapy (androgen deprivation therapy) in patients with metastatic hormone sensitive prostate cancer.
Primary outcome measures:
Radiological progression-free survival
Secondary outcome measures:
Overall survival
Partner:
Bayer
Indication:
Hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR).
Status:
The Phase III study ARASTEP is ongoing (2023-). The study evaluates the efficacy of darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.
Primary outcome measures:
Radiological progression-free survival (rPFS), measured by PSMA PET/CT assessed by independent central review.
Partner:
Bayer
Indication:
Metastatic castration-resistant prostate cancer (mCRPC)
Status:
The Phase III study OMAHA1 is ongoing (2023-). The study evaluates the safety, tolerability and efficacy of ODM-208/MK-5684 in combination with HRT for the treatment of patients with later-line mCRPC who have failed one prior new hormonal agent (NHA) and one or two prior taxane-based chemotherapies.
Primary outcome measures:
Overall survival (OS) and radiographic progression-free survival (rPFS) by AR LBD mutation status.
Partner:
Merck/MSD
Indication:
Metastatic castration-resistant prostate cancer (mCRPC)
Status:
The Phase III study OMAHA2a is ongoing (2023-). The study evaluates the safety, tolerability and efficacy of ODM-208/MK-5684 in combination with HRT for the treatment of patients with front-line mCRPC who have failed one prior NHA.
Primary outcome measures:
Overall survival (OS) and radiographic progression-free survival (rPFS) by AR LBD mutation status.
Partner:
Merck/MSD
Indication:
Metastatic castration-resistant prostate cancer (mCRPC)
Status:
The Phase II study CYPIDES is ongoing (2018-) The study evaluates the safety and tolerability of the drug candidate in prostate cancer patients.
Primary outcome measures:
Maximum tolerated dose.
Partner:
Merck/MSD
Indication:
Insomnia
Status:
Orion has an ongoing Phase IIa clinical trial with tasipimidine for the treatment of insomnia, which is often associated with pain and difficult to treat.
Indication:
Acute and chronic pain
Status:
Phase I trial investigated the tolerability and safety of the drug candidate in healthy volunteers. Phase II program in acute and chronic pain due to start in late 2024/early 2025.
Indication:
Cancer / solid tumours
Status:
Orion has ongoing a Phase I clinical trial with ODM-212 molecule, which is a TEAD inhibitor aimed for the treatment of solid tumours with YAP/TEAD activation. The study evaluates the safety and tolerability of ODM-212.
