Bayer releases new Phase III data on darolutamide plus androgen

German pharma major Bayer (BAYN: DE) says that new late-breaking data from the pivotal Phase III ARASENS trial confirm consistent overall survival (OS) benefits of darolutamide plus androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC), in pre-specified subgroups based on extent of metastatic spread (bone or visceral metastases) and alkaline phosphatase (ALP) value (< or ≥ upper limit of normal [ULN] at study entry), compared to a current standard of care, ADT plus docetaxel. Adverse event (AE) rates were similar in both treatment arms.

Of the 1,306 mHSPC patients who were randomized, 79.5% had bone metastases (M1b) and 17.5% had visceral metastases (M1c); 55.5% had ALP ≥ ULN. Extent of metastatic spread and ALP value are known prognostic factors in patients with mHSPC.

“These latest results from the ARASENS trial reaffirm the overall survival benefits of darolutamide plus ADT and docetaxel across various patient segments in mHSPC, and provide treating physicians with further detail on those who may benefit from this therapy as it becomes available,” said Dr Karim Fizazi, Professor of Medicine at the Institute Gustave Roussy, Villejuif, France.