Bayer has reported positive results from its Phase III ARAMIS trial after it met the primary endpoint.

Results showed that darolutamide significantly improved metastasis-free survival (MFS) compared to placebo.

They also demonstrated that the safety profile and tolerability of darolutamide were similar to previously published data.

ARAMIS (‘Androgen Receptor inhibiting Agent for MetastatIc-free Survival’) is a randomised, multi-centre trial that examined the safety and efficacy of oral darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

The double-blind, placebo-controlled trial enrolled more than 1,500 men who were under the treatment of androgen deprivation therapy (ADT) as standard of care and were at risk for developing metastatic disease.

Patients were randomised in a 2:1 ratio to receive 600mg of darolutamide twice a day or placebo.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
“Despite recent advances in nmCRPC, there remains a high unmet need for additional treatment options.”

Secondary endpoints of the trial included overall survival (OS), time to first symptomatic skeletal event (SSE), time to initiation of first cytotoxic chemotherapy, and time to pain progression.

Bayer Pharmaceutical Division oncology development head and senior vice-president Scott Fields said: “Despite recent advances in nmCRPC, there remains a high unmet need for additional treatment options that delay the time to metastases with a manageable safety profile.”

Darolutamide has been jointly developed by Bayer and pharmaceutical company Orion as an oral and non-steroidal androgen receptor (AR) antagonist.

The drug features a distinct chemical structure that binds to the receptor with high affinity and shows strong antagonistic activity, restricting the growth of prostate cancer cells.