ODM-201, which is also known as darolutamide or BAY-1841788, is a prostate cancer therapy that Orion and Bayer are developing.

It is aimed at treating advanced forms of the disease known as castrate-resistant prostate cancer, or CRPC, and metastatic hormone sensitive prostate cancer, or mHSPC.

How ODM-201 works

Its developers hope ODM-201 works when other prostate cancer treatments can’t.

Androgen deprivation therapies, also known as hormone therapies, are common treatments for the disease. Their aim is to reduce levels of male hormones known as androgens that spur the cancer on.

Androgens such as testosterone usually contribute to prostate health. But they can prompt cancer cells to grow and multiply. Androgens bind to androgen receptors on the outside of prostate cells, passing on signals that the cells should grow. This occurs whether the cells are normal or cancerous.

Some prostate cancers become castrate-resistant, no longer responding to hormone therapies. They continue to grow and develop, even when androgen levels are low.

ODM-201 is an androgen receptor antagonist. It binds to the receptor, preventing androgen from passing on growth signals to cancer cells. This slows or prevents the cancer’s growth.

Since ODM-201 does not target androgen, but its receptor, researchers believe it will work against prostate cancer that is resistant to hormone therapy.

ODM-201 in clinical trials

The Phase 1/2 ARADES clinical trial (NCT01317641) assessed the safety and effectiveness of ODM-201 in men with metastatic CRPC — that is, prostate cancer that has spread to other parts of the body.

Twenty-four patients participated in the trial’s Phase 1 stage, which tested doses of ODM-201 ranging from 200 to 1,800 mg per day.

In the Phase 2 stage, researchers divided 124 CRPC patients into groups. One group had no previous therapy, the second had received chemotherapy, and the third had CYP17 inhibitor treatment. The patients were randomly assigned to 200 mg, 400 mg, or 1,400 mg of ODM-201 per day for three months.

Around a third of the patients in each dose group responded to treatment. Researchers defined a response as a 50 percent or greater reduction in a prostate cancer biomarker known as prostate specific antigen, or PSA. Measuring PSA levels is a common way to diagnose prostate cancer. The researchers published their findings in the medical journal Lancet Oncology.

In an extension of the ARADES trial (NCT01429064), researchers followed patients who had not previously received CYP17 inhibitor treatment for an average of 11 months. Sixty-eight percent of those who had not had chemotherapy responded to ODM-201, as did 43 percent who had chemotherapy.

The study showed that the treatment to be well tolerated over an extended period. The team published its results in European Urology Focus

In 2014, Orion and Bayer decided to hold a Phase 3 trial, ARAMIS (NCT02200614), to assess ODM-201’s ability to combat non-metastatic CRPC.

It announced a second Phase 3 trial (NCT02799602), ARASENS, in 2016 that will assess whether a combination of ODM-201, a hormone therapy and the cancer drug Taxotere (docetaxel) is effective against mHSPC. Researchers are still recruiting patients for the trials.

Other information

The most common side effects associated with ODM-201 that have surfaced in the trials include anemia, diarrhea, fatigue, weakness, hot flashes, and decreased appetite.

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