Bayer’s Nubeqa is approved by the US FDA as a treatment for metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC), in combination with docetaxel. Image Credit: Below the Sky / Shutterstock.

Bayer is set to pursue a label expansion for Nubeqa (darolutamide) in a distinct subgroup of prostate cancer patients—those with metastatic hormone-sensitive prostate cancer (mHSPC)—after announcing that a Phase III trial with the therapy met its primary endpoint.

The company did not disclose detailed trial data, only stating that the combination  of Nubeqa and androgen deprivation therapy (ADT) demonstrated “a statistically significant and clinically meaningful increase”, compared to the placebo and ADT combination, in the radiological progression-free survival (rPFS), the study’s primary endpoint. Bayer plans to share the detailed results from the trial at an upcoming scientific conference.

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Nubeqa has been approved by the US Food and Drug Administration (FDA) to treat patients with mHSPC, but only in combination with docetaxel chemotherapy. The company now plans to seek approval for the drug’s use mHSPC indication sans additional chemotherapy. To that end, Bayer plans to submit the Phase III ARANOTE trial data for regulatory approval.

“Following potential regulatory approval, physicians will be able to tailor Nubeqa treatment plans with or without docetaxel based on individual patient’s needs,” said Christian Rommel, head of research and development at Bayer’s pharmaceuticals division.

“[These] results build on the established efficacy and tolerability profile of NUBEQA. We are looking forward to future outcomes of our clinical development program investigating the compound across multiple prostate cancer stages and indications.”

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Nubeqa is an androgen receptor inhibitor (ARi), which was first approved by the US FDA to treat metastatic castration-resistant prostate cancer (mCRPC). The therapy generated €869m ($949m) in sales last year, as per Bayer’s financials. Nubeqa sales are expected to increase to over $3.6bn in 2029, as per GlobalData analysis, as the company seeks to broaden its use in multiple subgroups of prostate cancer patients.

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Bayer is also evaluating the Nubeqa and ADT combination in non-metastatic HSPC patients in the Phase III ARASTEP trial (NCT05794906). The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) is evaluating Nubeqa as an adjunct therapy for localised prostate cancer with a very high risk of recurrence in a Phase III DASL-HiCaP study (NCT04136353).