▎WuXiEdited by the Kant Content Team

BayerBayer announced today that its Phase 3 ARANOTE clinical trial has met the primary endpoint.Its oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) significantly improves radiographic progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).Bayer Plans to Present Key Data at Upcoming Scientific Conferences and Discuss These Data with the U.S. FDA to Obtain Relevant Regulatory Approvals.

Prostate cancer is one of the most commonly diagnosed malignant tumors in men globally.At the time of diagnosis, most men have localized prostate cancer, which can be treated with surgery or radiation therapy.When the disease spreads or metastasizes, it develops into metastatic prostate cancer.The growth of prostate cancer cells is androgen-dependent, so patients with metastatic prostate cancer are initially sensitive to ADT treatment, namely mHSPC.Patients who still experience disease progression after continuous ADT will develop metastatic castration-resistant prostate cancer (mCRPC).

The ARANOTE trial announced this time is a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy and safety of Nubeqa combined with ADT for the treatment of patients with mHSPC. A total of 669 patients were randomly assigned to receive ADT withTwice DailyTreatment with Nubeqa (or placebo) combination therapy.

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The analysis shows,Compared with placebo plus ADT, Nubeqa plus ADT demonstrated a statistically and clinically significant increase in rPFS.The safety results of the combination therapy were consistent with the previous safety profile, and no new signals were observed. Including these study results, Nubeqa has demonstrated positive data in two pivotal Phase 3 studies for the treatment of mHSPC patients, both in combination with and without docetaxel.

Nubeqa is an oral androgen receptor inhibitor with a unique chemical structure that binds to the androgen receptor with high affinity, demonstrating strong antagonistic activity, thereby inhibiting receptor function and the growth of prostate cancer cells.Nubeqa, jointly developed by Bayer and Orion, has been launched in the United States.ApprovedUsed in combination with docetaxel for the treatment of adult patients with mHSPC and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC). This drug has also been approved in over 60 countries and regions worldwide, including the European Union, Japan, and China.