Additional ODM-208/MK-5684 Phase II data presented at ASCO-GU 2024
26 Enero 2024 - 1:00AM
Additional ODM-208/MK-5684 Phase II data presented at ASCO-GU 2024
ORION CORPORATION PRESS RELEASE 26 JANUARY 2024 at 09.00
EET Additional
ODM-208/MK-5684 Phase II data presented at ASCO-GU 2024Orion
presented yesterday at the 2024 ASCO GU Cancers Symposium a poster
with additional data from the ongoing Phase 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) with and without AR-LBD mutations. Previously published
data has focused on patients with androgen receptor gene (AR)
ligand-binding-domain (LBD) mutations. The new data reports initial
results in an extension cohort of mainly AR-LBD wild-type patients
combined with previously reported phase 2 data (AR-LBD
mutation-positive only).
Prostate cancer continues to be regulated by steroid hormones,
even in castration-resistant disease. Data from the Phase II
CYPIDES trial suggest that ODM-208/MK-5684 potently inhibits all
steroid-hormone biosynthesis with observed antitumor activity in a
heavily pretreated mCRPC population, especially in patients with
AR-LBD mutations.
In Phase II CYPIDES, at data cut-off, a total of 134 previously
treated mCRPC patients received 5mg of ODM-208/MK-5684 twice a day
with glucocorticoid/mineralocorticoid replacement and ongoing
androgen-deprivation therapy. Of the total, 66 patients had AR-LBD
mutation and 68 were AR-LBD wild-type. PSA (prostate-specific
antigen) responses occurred in men without AR-LBD mutations, but
were more frequent in those with such mutations. A decrease in PSA
levels of 50% or more occurred in 55.6% of patients with AR- LBD
mutation and in 16.7% of AR-wild-type patients. A decrease in PSA
levels of 30% or more occurred in 69.8% of patients with AR-LBD
mutation and in 30.0% of AR-wild-type patients. Results on other
endpoints are not yet mature and will be reported later. Adverse
events on ODM-208/MK-5684 were clinically manageable and the rate
of serious adrenal insufficiency remained low on hormone
replacement therapy (3.0%), although many patients continue on
treatment and further events are possible. The new data support and
are consistent with the previously reported results. “These results
support the continued importance of hormone-based treatments and
potential of ODM-208/MK-5684 as a new inhibitor of AR driven growth
of prostate cancer, even in heavily treated patients with advanced
disease. Interestingly, the results in the patients with
AR-wild-type suggest that they benefit from ODM-208/MK-5684 too,
although the PSA decrease was more frequently seen in the patients
with AR-LBD mutation. We look forward to having further data both
in AR LBD positive and negative patients in the on-going Ph3
studies”, said Professor, M.D., Ph.D. Outi
Vaarala, Senior Vice President of Innovative Medicines and
Research and Development at Orion.
About ODM-208/MK-5684
ODM-208/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/MK-5684 is being developed through a
collaboration with MSD (tradename of Merck & Co., Inc. Rahway
NJ USA). The compound is being evaluated in two pivotal Phase 3
clinical trials in combination with hormone replacement therapy
(HRT), for the treatment of certain patients with metastatic
castration-resistant prostate cancer (mCRPC). Patients are now
enrolling in the trials, named OMAHA1 (NCT06136624) and OMAHA2a
(NCT06136650).
Contact person:Terhi Ormio, VP,
CommunicationsOrion Corporationtel. +358 50 966 4646e-mail:
terhi.ormio@orion.fi
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
employees at the end of the year. Orion's A and B shares are listed
on Nasdaq Helsinki.
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