Bayer and Orion’s darolutamide has demonstrated significant survival benefits as part of a combination treatment in patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to new late-stage results shared by the companies.
The phase 3 ARANOTE trial randomised more than 660 patients to receive 600mg of darolutamide twice daily or matching placebo, both in addition to androgen deprivation therapy (ADT).
The study met its primary endpoint, with the darolutamide combination significantly increasing radiological progression-free survival compared to placebo plus ADT.
The darolutamide combination also had a safety profile comparable to that of placebo plus ADT.
Prostate cancer is the second most common cancer in men, with an estimated 1.4 million cases diagnosed globally in 2020.
ADTs are often used as part of a combination treatment for patients with mHSPC, a stage of the disease in which the cancer has spread outside of the prostate to other parts of the body. However, most of those with mHSPC eventually progress to castration-resistant prostate cancer, at which point survival is limited.
Darolutamide, jointly developed by Bayer and Orion, is an oral androgen receptor inhibitor that works to impede the receptor function and the growth of prostate cancer cells.
The drug already holds approvals, under the brand name Nubeqa, to treat non-metastatic castration-resistant prostate cancer patients who are at high risk of developing metastatic disease, and in combination with ADT and docetaxel for those with mHSPC.
Commenting on the latest results for the therapy, Outi Vaarala, senior vice president of innovative medicines and research and development at Orion, said: “The results of the ARANOTE trial reconfirm that darolutamide… is a viable treatment option for patients with mHSPC.
“In these patients, darolutamide has now shown efficacy with and without docetaxel, and thus, pending regulatory approval, can provide choices for the personalised treatment regime.”
Bayer is now set to present detailed results from the study at an undisclosed scientific congress and will submit the data to global health authorities to support expanded use of darolutamide in mHSPC.
Beyond mHSPC, darolutamide is currently being evaluated across other stages of prostate cancer, including hormone-sensitive high-risk biochemical recurrence disease.