Darolutamide combo promising in Phase 3 prostate cancer trial

Bayer and Orion's darolutamide has shown substantial survival benefits as a combination treatment for patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to recent phase 3 ARANOTE trial results. This trial involved more than 660 patients who were randomly assigned to receive either 600mg of darolutamide twice daily or a matching placebo, both in addition to androgen deprivation therapy (ADT).

The study's primary endpoint was met, with the darolutamide combination significantly increasing radiological progression-free survival compared to the placebo plus ADT. Furthermore, the safety profile of the darolutamide combination was comparable to that of the placebo plus ADT.

Prostate cancer is the second most prevalent cancer in men, with approximately 1.4 million cases diagnosed worldwide in 2020. ADTs are commonly used as part of combination treatments for patients with mHSPC, a phase of the disease where the cancer has spread beyond the prostate to other body parts. Despite treatment, most patients with mHSPC eventually develop castration-resistant prostate cancer, where survival rates drop significantly.

Darolutamide, an oral androgen receptor inhibitor developed by Bayer and Orion, functions by impeding receptor action and reducing the growth of prostate cancer cells. The drug, marketed under the brand name Nubeqa, is already approved for treating non-metastatic castration-resistant prostate cancer patients at high risk of developing metastatic disease. It is also approved in combination with ADT and docetaxel for mHSPC patients.

Outi Vaarala, senior vice president of innovative medicines and research and development at Orion, remarked on the ARANOTE trial results, stating that they reaffirm darolutamide as a viable treatment option for patients with mHSPC. She noted that darolutamide has shown efficacy both with and without docetaxel, offering potential choices for personalized treatment regimens pending regulatory approval.

Bayer plans to present the detailed study results at a forthcoming scientific congress and will submit the data to global health authorities to support the expanded use of darolutamide in mHSPC. Beyond mHSPC, darolutamide is under evaluation for other stages of prostate cancer, including hormone-sensitive high-risk biochemical recurrence disease.