Bayer Targets Expanded Use Approval For Prostate Cancer Drug, Reveals Encouraging Data From Pivotal Study

On Monday, Bayer AG BAYRY said results from the Phase 3 ARANOTE trial have shown that darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54), in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The company adds that darolutamide plus ADT now has ‘positive data’ both with and without docetaxel.

The results were presented at the 2024 ESMO Congress and simultaneously published in The Journal of Clinical Oncology.

Bayer plans to submit the data from the ARANOTE trial to health authorities globally to support the expanded use of darolutamide in patients with mHSPC.

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Darolutamide is already approved for mHSPC under the brand name Nubeqa in combination with ADT and docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

The product was developed jointly by Bayer and a Finnish pharmaceutical company, Orion Corporation.

Consistent benefits in radiological progression-free survival (rPFS) were observed across patient subgroups, including high- and low-volume mHSPC, with a risk reduction by 40% and 70%, respectively.

An analysis of immature data of overall survival (OS), which measures the time from treatment until death from any cause, suggested a potential benefit with darolutamide plus ADT vs. placebo plus ADT.

The ARANOTE data also suggested numerical clinical benefits across all other secondary endpoints, including delaying the time to CRPC, PSA progression, pain progression, and initiation of subsequent systemic therapy compared to placebo plus ADT.

Incidences of treatment-emergent adverse events (TEAEs) were low (most were grade 1 or 2) and similar between treatment arms, and treatment discontinuations due to TEAEs were lower in patients receiving darolutamide compared to placebo plus ADT (6.1% vs 9.0%).

In the second quarter of 2024, Nubeqa generated sales of 380 million euros, up 89% year over year.

Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. Prostate cancer diagnoses are projected to increase from 1.4 million annually in 2020 to 2.9 million by 2040.

Image by PDPics from Pixabay

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