NEJM Evidence publishes results from Phase I/IIa CYPIDES trial with ODM-208
27 Dezembro 2023 - 6:00AM
NEJM Evidence publishes results from Phase I/IIa CYPIDES trial with
ODM-208
ORION CORPORATION PRESS RELEASE 27 DECEMBER 2023 at 11:00
EET NEJM
Evidence publishes results from Phase I/IIa CYPIDES trial with
ODM-208
The NEJM Evidence has published interim data from the first part
of Phase I/II CYPIDES trial evaluating the safety and efficacy of
ODM-208 (or MK-5684), an investigational, oral CYP11A1 inhibitor,
in heavily pretreated patients with metastatic castration-resistant
prostate cancer (mCRPC).
Prostate cancer continues to be regulated by steroid hormones,
even in castration-resistant disease. Results from the Phase I/IIa
CYPIDES trial suggest that ODM-208 potently inhibits all
steroid-hormone biosynthesis with observed antitumor activity in a
heavily pretreated mCRPC population, especially in patients with
androgen receptor gene (AR) ligand-binding-domain (LBD)
mutations.
In Phase I/IIa CYPIDES, a total of 92 previously treated mCRPC
patients received 5mg of ODM-208 twice a day with
glucocorticoid/mineralocorticoid replacement and ongoing
androgen-deprivation therapy. In phase I, 20 out of the total 47
patients had AR LBD mutation. In phase IIa, all 45 patients had AR
LBD mutation. A decrease in PSA (prostate-specific antigen) levels
of 50% or more occurred in 14/19 (73.7%) patients with AR LBD
mutation and 2/23 (8.7%) AR-wild-type patients in phase I, and in
24/45 (53.3%) patients with AR LBD mutation in phase IIa. Median
circulating testosterone levels declined from 3.0 ng/dl at baseline
to undetectable levels within the first week of ODM-208 treatment
in 46/53 (87%) patients. Although well tolerated by most patients,
treatment-related adrenal insufficiency was the most common safety
finding. Overall 17 (36.2%) of patients in Phase I and 6 (13.3%) of
patients in Phase IIa experienced adrenal insufficiency requiring
adjustment of hormone replacement therapy and/or additional
supplementation, after which the ODM-208 treatment commonly
continued.
“These results support the continued importance of hormone-based
treatments and potential of ODM-208 in prostate cancer, even in
heavily treated patients with advanced disease. Additional data
also shows promising improvement in managing the treatment-related
adrenal insufficiency. We look forward to having further data from
the latter part of the study both in AR LBD positive and negative
patients.”, said Professor, M.D., Ph.D. Outi
Vaarala, Senior Vice President of Innovative Medicines and
Research and Development at Orion.
About ODM-208
ODM-208 (or MK-5684) is an investigational oral, non-steroidal
and selective inhibitor of the CYP11A1 enzyme discovered and
developed by Orion for the treatment of hormone-dependent cancers,
such as prostate cancer. ODM-208 is being developed through a
collaboration with MSD (tradename of Merck & Co., Inc. Rahway
NJ
USA).
Link to the article:
https://evidence.nejm.org/doi/full/10.1056/EVIDoa2300171
Contact person:Terhi Ormio, VP,
CommunicationsOrion Corporationtel. +358 50 966 4646
Publisher:Orion
CorporationCommunicationsOrionintie 1A, FI-02200 Espoo,
Finlandwww.orion.fi
Orion is a globally operating Finnish pharmaceutical company – a
builder of well-being. We develop, manufacture and market human and
veterinary pharmaceuticals and active pharmaceutical ingredients.
Orion has an extensive portfolio of proprietary and generic
medicines and self-care products. The core therapy areas of our
pharmaceutical R&D are oncology and pain. Proprietary products
developed by Orion are used to treat cancer, neurological diseases
and respiratory diseases, among others. Orion's net sales in 2022
amounted to EUR 1,341 million and the company had about 3,500
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