Bayer's (BAYRY) Phase III Study on Nubeqa Combo Meets Goal

Bayer AG BAYRY announced that the phase III ARASENS study, which evaluated the use of oral androgen receptor inhibitor (ARi), Nubeqa (darolutamide), in combination with docetaxel and androgen deprivation therapy (ADT) for treating metastatic hormone-sensitive prostate cancer (mHSPC), has met the primary endpoint.

Data from the study showed that treatment with darolutamide in combination with docetaxel plus ADT significantly increased the overall survival (OS) in patients with mHSPC as compared to docetaxel and ADT, a standard of care. The overall incidence of adverse events reported was similar between treatment arms.

Bayer expects to discuss data from the study with health regulatory authorities across the world for filing marketing authorization application for the given indication.

Per the press release, the above-mentioned study is prospectively designed to evaluate the safety and efficacy of the combo of an ARi with docetaxel and ADT versus docetaxel and ADT in patients with mHSPC.

Shares of Bayer have declined 15.5% so far this year against the industry’s increase of 12.4%.

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Please note that darolutamide is being jointly developed by Bayer and Finland-based pharmaceutical company, Orion Corporation.

The FDA approved darolutamide under the brand name Nubeqa for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease in July 2019. The drug is also approved in the European Union, Japan and China for the same indication.

We note that darolutamide is also being studied for addressing various stages of prostate cancer. The phase III ARANOTE study is evaluating darolutamide plus ADT for treating mHSPC. Another phase III study is investigating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP).

Per the company, an estimated 1.4 million men were diagnosed with prostate cancer in 2020 worldwide, with 375,000 dying from the disease. There is also a significant need for new therapeutic options to improve treatment outcomes for patients with mHSPC.

Zacks Rank & Stocks to Consider

Bayer currently carries a Zacks Rank of #3 (Hold). Better-ranked stocks in the healthcare sector include GlaxoSmithKline plc GSK, Precision BioSciences, Inc. DTIL and Endo International plc ENDP, all sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

GlaxoSmithKline’s earnings estimates have been revised 9.3% upward for 2021 and 5.8% upward for 2022 over the past 60 days. The stock has rallied 12.1% year to date.

GlaxoSmithKline’s earnings have surpassed estimates in two of the trailing four quarters, missed the same once and matched it once.

Precision BioSciences’ loss per share estimates have narrowed 44.4% for 2021 and 20.1% for 2022, over the past 60 days.

Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters.

Endo International’s earnings estimates have been revised 24% upward for 2021 and 10.3% upward for 2022 over the past 60 days.

Endo International’s earnings have surpassed estimates in each of the trailing four quarters.

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