Investor Presentaiton
ORION
Orion's key clinical trials with darolutamide
Clinical trial and
treatment
Indication
Primary endpoint and results
ARAMIS
darolutamide + ADT
nmCRPC
Key secondary endpoints
Status
Metastasis free survival
prolongation by 22.0 months,
59% risk reduction (HR=0.41, p<0.001)
Overall survival
Overall survival
31% risk reduction (HR=0.69, p=0.003)
Approved
11
ARASENS
darolutamide + ADT
MHSPC
+ docetaxel
32.5% risk reduction
(HR 0.675, p<0.001)
ARANOTE
MHSPC
darolutamide + ADT
ARASTEP
BCR
darolutamide + ADT
Radiological progression-free survival
(study ongoing)
Radiological progression-free survival
(study ongoing)
Time to castration resistant PC
64% risk reduction (HR=0.36, p<0,001)
Approved
Overall survival
(study ongoing)
Metastasis free survival
Time to castration resistant PC
Overall survival
Overall incidence of treatment-emergent adverse events was similar between treatment arms (darolutamide group vs.
placebo group) both in ARAMIS and ARASENS trials
=
ADT androgen deprivation therapy
nmCRPC = non-metastatic castration-resistant prostate cancer
mHSPC metastatic hormone-sensitive prostate cancer
BCR biochemical relapse
Orion develops darolutamide in collaboration with Bayer.
Phase III
ongoing
Phase III
ongoing
Investor Presentation Orion CorporationView entire presentation