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.
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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.