Bayer seeks Nubeqa label expansion after Phase III success

Bayer is advancing its efforts to expand the use of Nubeqa (darolutamide) for treating a specific group of prostate cancer patients who have metastatic hormone-sensitive prostate cancer (mHSPC). This follows the successful results of a Phase III trial, which achieved its primary endpoint.

The company's announcement did not include the detailed trial data. However, it was revealed that the combination of Nubeqa and androgen deprivation therapy (ADT) showed a "statistically significant and clinically meaningful increase" in radiological progression-free survival (rPFS) compared to a combination of placebo and ADT. Bayer plans to present the detailed trial results at an upcoming scientific conference.

Currently, Nubeqa is approved by the US Food and Drug Administration (FDA) for treating patients with mHSPC, but only when used in combination with the chemotherapy drug docetaxel. Bayer now aims to gain approval for the use of Nubeqa in mHSPC without the need for additional chemotherapy. As part of this plan, the company will submit the data from the Phase III ARANOTE trial for regulatory approval.

Christian Rommel, who leads research and development in Bayer’s pharmaceuticals division, commented on the potential impact of this approval. He highlighted that post-regulatory approval, physicians could customize Nubeqa treatment plans with or without docetaxel, depending on individual patient needs. Rommel emphasized that these results reinforce the drug’s efficacy and tolerability profile, expressing optimism about the ongoing and future clinical development programs evaluating Nubeqa across various stages and indications of prostate cancer.

Nubeqa functions as an androgen receptor inhibitor (ARi). It was initially approved by the FDA for the treatment of metastatic castration-resistant prostate cancer (mCRPC). According to Bayer’s financial reports, Nubeqa generated sales of €869 million ($949 million) last year. Projections from GlobalData estimate that Nubeqa’s sales could exceed $3.6 billion by 2029, as Bayer continues to explore its application across different subgroups of prostate cancer patients.

Moreover, Bayer is investigating the combination of Nubeqa and ADT in non-metastatic hormone-sensitive prostate cancer (HSPC) patients through the Phase III ARASTEP trial (NCT05794906). Another study, the Phase III DASL-HiCaP trial (NCT04136353), is being conducted by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) to evaluate Nubeqa as an adjunct therapy for localized prostate cancer with a very high risk of recurrence.

In summary, Bayer’s pursuit of a label expansion for Nubeqa highlights the company's commitment to enhancing prostate cancer treatment options. With promising trial results and ongoing studies, Bayer is positioned to potentially offer more flexible and effective treatment regimens for prostate cancer patients, aiming to address a broader spectrum of the disease.