9 February 2021 - - German pharmaceutical and life science company Bayer (OTC: BAYZF) and Finnish pharmaceutical developer Orion Corp. are expanding the global clinical development programme for the oral androgen receptor inhibitor Nubeqa (darolutamide) in prostate cancer, the companies said.

A new Phase III study ARANOTE will investigate Nubeqa in addition to androgen deprivation therapy versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC).

The study builds on the development programme comprising multiple studies, including the Phase III study ARASENS, which investigates Nubeqa combined with ADT and docetaxel compared to docetaxel and ADT alone in men with mHSPC.

In 2019, Nubeqa was approved in the US for the treatment of patients with nmCRPC. The ARAMIS study demonstrated proven efficacy and tolerability, including significant improvement in metastasis-free survival.

Nubeqa plus ADT showed the same low rate of permanent discontinuation due to adverse reactions compared to ADT alone (9% versus 9%).

The most frequent adverse reactions requiring discontinuation in patients who received Nubeqa included cardiac failure, and death.

Adverse reactions occurring more frequently in the Nubeqa arm (≥2% over placebo) were fatigue (16% versus 11%), pain in extremity (6% versus 3%) and rash (3% versus 1%). Nubeqa was not studied in women and there is a warning and precaution for embryo-fetal toxicity.

The ARANOTE trial will be a randomized, double-blind, placebo-controlled Phase III study of NUBEQA in addition to androgen deprivation therapy versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC).

The primary endpoint of this study is radiological progression-free survival, as measured as the time from the date of randomization to the date of first documentation of radiological progressive disease or death due to any cause, whichever occurs first.

The trial is expected to enroll about 555 men, with the first patients enrolled by the end of 1Q21.

Previously published in The New England Journal of Medicine, results in 1,509 patients from the Phase III ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival, with a median of 40.4 months (n=955) with Nubeqa plus androgen deprivation therapy, more than double the 18.4 months (n=554) for placebo plus ADT (p