Bayer, Orion's Nubeqa Achieves PFS Goal in Non-Docetaxel Metastatic Prostate Cancer

Bayer and Orion revealed on Wednesday that their androgen receptor inhibitor (ARi) Nubeqa (darolutamide), combined with androgen deprivation therapy (ADT), demonstrated significant improvement in radiological progression-free survival (rPFS) for men suffering from metastatic hormone-sensitive prostate cancer (mHSPC) during a Phase III clinical trial. The companies plan to discuss these findings with the FDA to support a potential approval.

The ARNOTE study enrolled 669 patients diagnosed with mHSPC, who were randomly assigned to receive either Nubeqa twice daily or a placebo alongside ADT. The top-line results indicated that the combination of Nubeqa and ADT substantially enhanced the primary endpoint of rPFS compared to the placebo and ADT group. Additionally, Nubeqa's safety profile remained consistent with previous studies, with no new safety concerns emerging. These detailed findings are set to be presented at an upcoming medical conference.

Following the approval by the US regulator to treat mHSPC in combination with docetaxel and ADT as per the ARASENS trial, Nubeqa now has additional data supporting its use in these patients without the need for taxane. Subject to its approval, physicians will have the flexibility to customize treatment plans with or without docetaxel based on individual patient requirements, according to Christian Rommel, head of R&D at Bayer.

Beyond mHSPC, Nubeqa in combination with ADT is also approved for treating non-metastatic castration-resistant prostate cancer in the US, Europe, China, and Japan. Furthermore, research is ongoing to investigate the drug across various stages and indications of prostate cancer, Rommel noted.

Nubeqa achieved global sales of €869 million ($950 million) last year, with projections for the current year expected to exceed €1 billion ($1.09 billion).