Trial closes gap between Bayer’s Nubeqa and rivals in prostate cancer

Bayer’s Nubeqa is making headway as a treatment for castration-resistant prostate cancer (CRPC), but could be on track to expand the eligible patient population for the drug thanks to new phase 3 data.

Just released results from the ARASENS trial show that adding Nubeqa (darolutamide) to docetaxel chemotherapy and androgen deprivation therapy (ADT) to switch off testosterone production helps men with castration-sensitive prostate cancer (CSPC).

The data will be filed with regulatory authorities to seek an expansion of the label for Nubeqa, according to Bayer, which developed Nubeqa in collaboration with Finland’s Orion.

The ARASENS trial was carried out in men whose HSPC had spread or metastasised to other parts of the body. Around 95% of prostate cancers are localised at diagnosis and treated with surgery or radiotherapy, but tend to relapse.

When this happens, the first line of drug treatment if the tumours are hormone-sensitive is ADT, with chemotherapy layered on top if needed. Most men with metastatic CSPC will eventually progress to CRPC, which has poor survival prospects.

Expanding Nubeqa’s approved uses is essential Bayer and Orion as they try to wrest market share from other more established drugs in the oral androgen receptor inhibitor class, including Johnson & Johnson’s Erleada (apalutamide) and Pfizer/Astellas’ Xtandi (enzalutamide) which have become standard therapies at several different stages of prostate cancer.

Erleada and Xtandi have both been approved for non-metastatic CRPC as well as metastatic CSPC for a couple of years, so Bayer and Orion are playing catch-up in the market.

The two partners reckon that their drug may have a safety advantage over its rivals and has the potential to break through the €1 billion sales barrier, although some analysts think that may be a tough proposition given that the efficacy of the drugs are comparable, and physicians have more experience with Erleada and Xtandi.

Bayer said in its third quarter results that it is expecting sales of Nubeqa in its current indication of non-metastatic CRPC to reach between €200 million and €250 million this year, primarily from the US but with momentum picking up in Europe centred for now in Germany.

The company doesn’t yet break out specific Nubeqa sales in its quarterly updates as it lies outside its top 15 products, but previously said it expected the drug to enter that category before the end of this year.

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