Bayer and Orion Corporation announced the expansion of the global clinical development programme for the investigational androgen receptor (AR) antagonist BAY-1841788 (ODM-201) in the area of prostate cancer. A new phase III study ARASENS will evaluate the compound in combination with standard androgen deprivation therapy (ADT) and the chemotherapy docetaxel in men with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), who are starting first line hormone therapy.
BAY-1841788 (ODM-201) is an investigational oral AR-antagonist that has a unique chemical structure designed to block the growth of cancer cells through binding to the AR with high affinity and inhibiting the receptor function. The compound is currently in phase III development ARAMIS study for high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). The new trial ARASENS is expected to start the enrollment of patients towards the end of 2016.
“Although the treatment options for patients with advanced prostate cancer who are castration-resistant have evolved considerably in recent years, there were only few advances in the earlier, hormone-sensitive stage of metastatic disease. Novel treatment approaches are urgently needed for patients to delay the progress of the cancer and improve survival,” said Dr. Joerg Moeller, member of the executive committee of Bayer AG's Pharmaceutical Division and Head of Development. “Bayer’s commitment to prostate cancer research runs deep, and the initiation of ARASENS is the latest in a long line of studies designed to evaluate treatment options for patients with advanced disease.”
Bayer and Orion have recently expanded the 2014 agreement to include the joint development of BAY-1841788 (ODM-201) for mHSPC. Under that agreement, Bayer will commercialize the product globally; Orion has the option to co-promote BAY-1841788 in Europe, and is responsible for the manufacturing of the product.
“We believe that the profile of ODM-201 makes it an excellent treatment candidate for patients with metastatic hormone-sensitive prostate cancer. This is another example of how Orion’s oncology research is aiming to contribute to the benefit of patients. We are also happy to see Bayer’s continuous commitment to ODM-201”, said Dr Reijo Salonen, senior vice president of R&D at Orion.
ARASENS (A Randomized, double-blind, placebo-controlled phase III study of ODM 201 versus placebo in addition to standard Androgen deprivation therapy and docetaxel in patients with metastatic castration SENSitive prostate cancer) is planned to be initiated towards the end of 2016. Approximately 1,300 patients will be randomized (1:1 ratio) to receive either BAY-1841788 or placebo in combination with an ADT of investigator’s choice (LHRH agonist/antagonists or orchiectomy), started =12 weeks before randomization. Six cycles of docetaxel will be administered after randomization.
ARASENS adds to the ongoing clinical development program for BAY-1841788, which includes ARAMIS (NCT02200614), a randomized, phase III, multicenter, double-blind, placebo-controlled trial evaluating patients with non-metastatic CRPC who are at high risk for developing metastatic disease. ARAMIS is currently enrolling patients.
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