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

Bayer recently shared encouraging top-line results from its phase 3 ARANOTE trial, examining the efficacy of Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) for men diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC). According to the findings, the primary endpoint was successfully achieved, demonstrating a significant improvement in radiological progression-free survival (rPFS) for patients treated with Nubeqa plus ADT compared to those who received a placebo in addition to ADT.

The safety profile of Nubeqa was consistent with earlier studies, with no new safety concerns reported. The drug has already earned approval in the United States for use with docetaxel for mHSPC and for patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

The ARANOTE trial was a robust, randomized, double-blind, placebo-controlled study that included 669 participants. Patients were administered 600mg of Nubeqa twice daily in combination with ADT. The study's secondary endpoints encompassed overall survival and the time taken to reach various cancer progression milestones.

These findings mark a significant milestone in the ongoing development and approval of Nubeqa, offering new hope for patients with mHSPC.