Reduce the risk of death by 32.5%!

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In a phase 3 clinical trial in patients with metastatic hormone-sensitive prostate cancer (mHSPC), the combination of androgen deprivation therapy (ADT) ) + chemotherapy (docetaxel), Bayer's new prostate cancer drug Nubeqa (darolutamide, darolutamide) + ADT + chemotherapy regimen reduced the risk of death by 32.

Based on the data, Bayer is "seeking the fastest possible regulatory timeline" to bring Nubeqa to patients with mHSPC, Robert LaCaze, head of Bayer's pharmaceutical division's oncology business, said in a statement

Positive data from Phase 3 ARASENS trial will pit Nubeqa against 2 competing androgen receptor inhibitors - Pfizer/Astellas Xtandi (enzalutamide) and Johnson & Johnson Erleada (apalutamide, Apa other amines) collide

Erleada is the first of 3 drugs to enter the mHSPC (also known as metastatic castration-sensitive prostate cancer [mCSPC]) market

Three months later, Xtandi followed Erleada into the mHSPC market

Although numerically similar, Nubeqa's Phase 3 ARASENS trial has one key difference from the two trials above

Last February, Bayer and partner Orion launched a Phase 3 ARANOTE trial with their own ADT as a control group

Bayer has high hopes for Nubeqa, which had previously expected peak annual sales of more than 1 billion euros

In early 2012, Xtandi was first approved by the US FDA for the treatment of metastatic castration-resistant prostate cancer (mCRPC), and the drug brought Astellas 411.

Nubeqa was approved by the US FDA in July 2019, and the current indication is limited to nmCRPC

Reference source: ASCO GU: Bayer tees up another 3-way battle against Pfizer-Astellas, J&J with new Nubeqa prostate cancer data