Bayer (BAYRY) Meets Primary Goal in Nubeqa Expanded-Use Study

Core Insights - Bayer's darolutamide in combination with androgen deprivation therapy (ADT) has shown significant improvement in radiological progression-free survival (rPFS) compared to placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC) [10] - The treatment was well tolerated and exhibited a safety profile consistent with previous studies in advanced prostate cancer [1][10] - Bayer plans to submit study data to global health authorities for regulatory applications to expand darolutamide's label in mHSPC patients [12] Company Developments - Darolutamide is already approved under the brand name Nubeqa for non-metastatic castration-resistant prostate cancer in over 85 countries and in combination with ADT and docetaxel for mHSPC in more than 80 markets, including the US, Japan, EU, and China [4] - The ARANOTE study is part of a broader clinical development program for darolutamide, which includes various stages of prostate cancer treatment [5] - Bayer's stock gained 3.3% following the announcement of the study results, although it has seen a year-to-date decline of 21.1% compared to the industry's growth of 23.4% [11] Industry Context - Prostate cancer is the second most prevalent cancer and the fifth leading cause of cancer-related deaths among men globally, with approximately 1.4 million diagnoses and around 375,000 deaths in 2020 [6] - The ongoing evaluation of darolutamide in a late-stage study for localized prostate cancer with a high risk of recurrence indicates the company's commitment to addressing various prostate cancer stages [3]