Bayer's prostate cancer combo drug boosts survival in phase 3

Bayer has announced positive topline results from its phase 3 ARANOTE trial, which tested Nubeqa (darolutamide) combined with androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC).

The trial successfully met its primary endpoint, showing an increase in radiological progression-free survival (rPFS) for patients receiving Nubeqa plus ADT compared to those receiving a placebo plus ADT.

The safety profile of Nubeqa remained consistent with previous findings, with no new safety signals observed. The drug is already approved in the U.S. for use in combination with docetaxel for mHSPC and for non-metastatic castration-resistant prostate cancer (nmCRPC).

The ARANOTE trial was a randomized, double-blind, placebo-controlled study involving 669 patients. It assessed the efficacy and safety of 600mg of Nubeqa taken twice daily plus ADT. Secondary endpoints included overall survival and time to various cancer progression milestones.