Bayer pads blockbuster case for Nubeqa with phase 3 win in metastatic prostate cancer

Bayer pads blockbuster case for Nubeqa with phase 3 win in metastatic prostate cancer

Bayer’s blockbuster hopes for Nubeqa just got a little brighter, thanks to a phase 3 trial win that could result in the drug reaching more patients. 

A combination of Bayer’s androgen receptor inhibitor Nubeqa plus standard of care trumped standard care alone at prolonging the lives of men with metastatic hormone-sensitive prostate cancer (mHSPC), data from the company’s late-stage Arasens study show.

Paired with the chemotherapy docetaxel and androgen deprivation therapy (ADT), Nubeqa significantly boosted overall survival compared to just docetaxel and ADT, which is considered a standard of care in men with mHSPC, Bayer said Friday.

The data bode well for Nubeqa’s potential entry into a wider pool of prostate cancer patients. Bayer is hoping to turn Nubeqa into a blockbuster, but it will need to expand the drug’s reach beyond nonmetastatic disease to get there, Bayer’s pharma chief Stefan Oelrich said on a May conference call. The drug is currently indicated for men with non-metastatic castration-resistant prostate cancer (nmCRPC).

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The pressure is on for Bayer to find new revenue drivers as two of its top sellers, Eylea and Xarelto, inch toward a 2023 patent cliff. In the meantime, it’s counting on new launches like Nubeqa, Viktravi and the Merck-partnered heart failure med Verquvo to pick up the slack.

As of the third quarter, Nubeqa had yet to join the ranks of Bayer’s 15 best-selling drugs, meaning its sales were less than the €62 million ($71 million) generated by radiotherapy Xofigo. Meanwhile, Johnson & Johnson’s Nubeqa rival Erleada generated $344 million in worldwide sales for the period, while Pfizer and Astellas’ competitor Xtandi made $309 million.

Bayer says it will present the mHSPC results at an upcoming medical conference and discuss them with regulators.

An estimated 1.4 million men were diagnosed with prostate cancer in 2020, with about 375,000 worldwide dying from the disease, Bayer noted in a press release. At the time of diagnosis, most men have localized prostate cancer, which can be treated with surgery or radiotherapy.

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Men with mHSPC start treatment with hormone therapy like ADT, androgen receptor inhibitors (ARi) plus ADT, or a combination of docetaxel and ADT, Bayer said. Nevertheless, most men with mHSPC eventually progress to castration-resistant prostate cancer (CRPC), which has limited survival, outlining the need for a new treatment option.

Bayer’s Arasens phase 3 pitted the Nubeqa combo regimen against docetaxel and ADT plus placebo in 1,306 newly diagnosed mHSPC patients, Bayer said. The rate of reported side effects was similar between treatment arms.

Bayer is studying a combination of Nubeqa and ADT without chemotherapy in a separate phase 3 called Aranote.

This story is brought to you by Fierce Pharma.

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