Orion and MSD Announce Initiation of Two Phase 3 Trials Evaluating ODM-208/MK5684 in Certain Patients with Metastatic Castration-Resistant Prostate Cancer
05 Januar 2024 - 12:45PM
Orion and MSD Announce Initiation of Two Phase 3 Trials Evaluating
ODM-208/MK5684 in Certain Patients with Metastatic
Castration-Resistant Prostate Cancer
ORION CORPORATION PRESS RELEASE05 JANUARY 2023 at 13:45
EET Orion
and MSD Announce Initiation of Two Phase 3 Trials Evaluating
ODM-208/MK5684 in Certain Patients with Metastatic
Castration-Resistant Prostate Cancer
- OMAHA1 and OMAHA2a are the first Phase 3 trials to be initiated
for ODM-208/MK5684
Orion Corporation (“Orion”) and MSD (known as Merck & Co.,
Inc., Rahway, N.J., USA in the United States and Canada) have
initiated two pivotal Phase 3 clinical trials evaluating
ODM-208/MK5684, an investigational CYP11A1 inhibitor, 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).
“The start of our co-development Phase 3 program with MSD
provides exciting opportunities to evaluate the potential of
ODM-208/MK5684 as a novel treatment of mCRPC, both in front-line
and late-line patients, including those with and without androgen
receptor ligand binding domain (AR LBD) mutations,” said Professor
Outi Vaarala, Senior Vice President, Innovative
Medicines and Research and Development, Orion. “Our ultimate aim is
to bring innovative medicines to all patients with unmet need, and
we look forward to the beginning of these studies with our partner,
MSD.”
“By inhibiting CYP11A1 enzyme activity, we believe
ODM-208/MK5684 represents a compelling approach to suppress the
production of steroid hormones, a key driver of prostate cancer,”
said Dr. Scot Ebbinghaus, Vice President, global
clinical development, MSD Research Laboratories. “The initiation of
these two Phase 3 trials of ODM-208/MK5684 in different stages of
mCRPC, in collaboration with Orion, demonstrates our continued
commitment to exploring innovative new approaches and pathways to
treat this complex disease.”
OMAHA1 is a randomized, open-label Phase 3 trial evaluating
ODM-208/MK5684 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 compared to an alternative NHA (abiraterone or
enzalutamide). The trial will enroll an estimated 1,200 patients
around the world. The primary endpoints are overall survival (OS)
and radiographic progression-free survival (rPFS) by AR LBD
mutation status. Secondary endpoints include time to first
subsequent therapy (TFST), objective response rate (ORR) and
duration of response (DOR).
OMAHA2a is a randomized, open-label Phase 3 trial evaluating
ODM-208/MK5684 in combination with HRT for the treatment of
patients with front-line mCRPC who have failed one prior NHA
compared to physician’s choice of NHA (abiraterone or
enzalutamide). The trial will enroll an estimated 1,500 patients
around the world. The primary endpoints are OS and rPFS by AR LBD
mutation status. Secondary endpoints include TFST, ORR and DOR.
About ODM-208/MK-5684
ODM-208/MK5684 is an oral, non-steroidal and selective inhibitor
of the CYP11A1 enzyme discovered and developed by Orion and is
being investigated for the treatment of hormone-dependent cancers,
such as prostate cancer. By inhibiting CYP11A1 enzyme activity,
ODM-208/MK5684 is designed to suppress the production of all
steroid hormones and their precursors that may activate the
androgen receptor signaling pathway.
About metastatic castration-resistant prostate
cancer
Development of prostate cancer is often driven by male sex
hormones called androgens, including testosterone. In patients with
mCRPC, their prostate cancer grows and spreads to other parts of
the body, despite the use of androgen-deprivation therapy to block
the action of male sex hormones. Approximately 10-20% of patients
with prostate cancer are estimated to develop castration-resistant
prostate cancer (CRPC) within five years, with at least 84% of
these patients presenting with metastases at the time of CRPC
diagnosis. Of patients with no metastases at CRPC diagnosis, 33%
are likely to develop metastases within two years. mCRPC is
associated with a significant mortality rate.
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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