Inside information: Phase III ARANOTE trial of darolutamide in combination with androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer meets primary endpoint
2024年7月17日 - 2:30PM
ORION CORPORATION STOCK EXCHANGE RELEASE – INSIDE INFORMATION17
JULY 2024 at 8.30 EEST
Inside
information: Phase III ARANOTE trial of darolutamide in combination
with androgen deprivation therapy in men with metastatic
hormone-sensitive prostate cancer meets primary endpoint
- Orion and Bayer’s Phase III ARANOTE
trial meets primary endpoint, significantly increasing radiological
progression-free survival (rPFS) with darolutamide + androgen
deprivation therapy (ADT) compared to placebo plus ADT.
- Safety analysis shows darolutamide
plus ADT to be comparable to placebo plus ADT, reconfirming the
established tolerability profile of darolutamide as observed in the
ARAMIS and ARASENS trials.
- Darolutamide plus ADT now has positive data both with and
without docetaxel based on two pivotal phase III studies in
metastatic hormone-sensitive prostate cancer (mHSPC).
- Bayer plans to present the pivotal
data at a forthcoming scientific congress and prepare for
submission with health authorities globally to extend the
indication of darolutamide.
The Phase III ARANOTE trial, investigating darolutamide plus ADT
in patients with metastatic hormone-sensitive prostate cancer
(mHSPC), has met its primary endpoint of rPFS. Darolutamide plus
ADT significantly increased rPFS compared to placebo plus ADT. The
safety data were comparable between both treatment arms and
reconfirm the established tolerability profile of darolutamide in
advanced prostate cancer. Darolutamide is already approved under
the brand name Nubeqa® for the treatment of patients with
non-metastatic castration-resistant prostate cancer (nmCRPC), who
are at high risk of developing metastatic disease, and patients
with metastatic hormone-sensitive prostate cancer (mHSPC, in
combination with ADT and docetaxel).
“The results of the ARANOTE trial reconfirm that darolutamide, a
compound discovered by Orion scientists, is a viable treatment
option for patients with metastatic hormone-sensitive prostate
cancer. In these patients, darolutamide has now shown efficacy with
and without docetaxel, and thus, pending regulatory approval, can
provide choices for the personalised treatment regime. I would like
to thank all the patients and the investigators who participated in
the ARANOTE trial,” said Professor, M.D., Ph.D. Outi
Vaarala, Senior Vice President of Innovative Medicines and
Research & Development at Orion.
Detailed results of the ARANOTE trial are planned to be
presented at a forthcoming scientific congress. Bayer plans to
submit the data from the study to relevant global health
authorities to support expanded use of darolutamide in men with
mHSPC.
ARANOTE is part of a robust clinical development program
investigating darolutamide across various stages of prostate
cancer, which includes the Phase III ARASTEP trial evaluating
darolutamide plus ADT versus ADT alone in hormone-sensitive
high-risk biochemical recurrence (BCR) prostate cancer, who have no
evidence of metastatic disease by conventional imaging and a
positive PSMA PET/CT at baseline. Furthermore, darolutamide is also
being investigated by Bayer in the collaborative Phase III
DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand
Urogenital and Prostate Cancer Trials Group (ANZUP). The study
evaluates darolutamide as an adjuvant treatment for localized
prostate cancer with very high risk of recurrence.
About the ARANOTE trialThe ARANOTE trial is a
randomized, double-blind, placebo-controlled Phase III study
designed to assess the efficacy and safety of darolutamide plus ADT
in patients with mHSPC. A total of 669 patients were randomized to
receive 600mg of darolutamide twice daily or matching placebo in
addition to ADT.
The primary endpoint of this study is rPFS, measured as time
from randomization to date of first documented radiological
progressive disease or death due to any cause, whichever occurs
first. Secondary endpoints include overall survival (time to death
from any cause), time to first castration-resistant event, time to
initiation of subsequent anti-cancer therapy, time to
prostate-specific antigen (PSA) progression, PSA undetectable
rates, time to pain progression, and safety assessments.
About metastatic hormone-sensitive prostate
cancerProstate cancer is the second most common cancer in
men and the fifth most common cause of cancer death in men
worldwide.1 In 2020, an estimated 1.4 million men were diagnosed
with prostate cancer, and about 375,000 died from the disease
worldwide.2
At the time of diagnosis, most men have localized prostate
cancer, meaning their cancer is confined to the prostate gland and
can be treated with curative surgery or radiotherapy. mHSPC is a
stage in the disease where the cancer has spread outside of the
prostate to other parts of the body. Up to 10% of men will already
present with mHSPC when first diagnosed.3, 4, 5 For patients with
mHSPC, ADT is the cornerstone of treatment, often in combination
with chemotherapy docetaxel and/or an androgen receptor inhibitor
(ARi). Despite treatment, most men with mHSPC will eventually
progress to castration-resistant prostate cancer (CRPC), a
condition with limited survival.
About darolutamideDarolutamide is an oral ARi
with a distinct chemical structure that binds to the androgen
receptor with high affinity and exhibits strong antagonistic
activity, thereby inhibiting the receptor function and the growth
of prostate cancer cells. The low potential for blood-brain barrier
penetration for darolutamide is supported by preclinical models and
neuroimaging data in healthy humans. This is also supported by the
overall low incidence of central nervous system (CNS)-related
adverse events (AEs) compared to placebo as seen in the ARAMIS
Phase III trial and the maintained verbal learning and memory
observed in the darolutamide arm of the Phase II ODENZA trial.
Darolutamide is approved under the brand name Nubeqa® in more
than 85 countries around the world for the treatment of patients
with non-metastatic castration-resistant prostate cancer (nmCRPC),
who are at high risk of developing metastatic disease. It is also
approved in combination with ADT and docetaxel for the treatment of
patients with mHSPC in over 80 markets including the U.S., Japan,
EU, and China. The product is developed jointly by Orion and
Bayer.
Orion Corporation
Liisa HurmePresident and CEO |
|
Outi VaaralaSVP, Innovative Medicines and Research &
Development |
|
Contact
person:Outi Vaarala, SVP, Innovative Medicines and
Research & Development, Orion CorporationTel. +358 10 426
3472outi.vaarala@orionpharma.com
Reference
- Sung H et al. Ca Cancer J Clin
2021; 71:209–249.
- Global Cancer Statistics 2020:
GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36
Cancers in 185 Countries. CA: A Cancer Journal for Clinicians.
https://acsjournals.onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21660
Accessed: June 2024.
- Piombino C et al. Cancers (Basel).
2023 Oct 11;15(20):4945.
- Helgstrand JT et al. Cancer.
2018;124(14):2931-2938.
- Buzzoni C et al. Eur. Urol.
2015;68:885–890.
Publisher:Orion
CorporationCommunicationsOrionintie 1A, FI-02200 Espoo,
Finlandhttp://www.orion.fi/en
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Orion is a globally operating Finnish pharmaceutical company – a
builder of well-being for over a hundred years. We develop,
manufacture and market human and veterinary pharmaceuticals and
active pharmaceutical ingredients. Orion has an extensive portfolio
of proprietary and generic medicines and consumer health 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 2023 amounted to EUR 1,190 million and
the company had about 3,600 employees at the end of the year.
Orion's A and B shares are listed on Nasdaq Helsinki.