Bayer Korea said Monday that the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) has received approval from the Ministry of Food and Drug Safety (MFDS) for treating patients with metastatic hormone-sensitive prostate cancer (mHSPC) as a two-drug regimen in combination with androgen deprivation therapy (ADT).

The indication expansion allows Nubeqa to be used as a two-drug regimen in combination with ADT and the existing three-drug regimen of ADT plus the chemotherapy agent docetaxel.

The approval was based on positive results from the ARANOTE study, a global phase 3 clinical trial that evaluated the efficacy and safety of a two-drug regimen of Nubeqa plus ADT in 669 patients with mHSPC.

Results showed that the Nubeqa arm significantly reduced the risk of radiologic progression or death by 46 percent compared to the placebo (HR 0.54; 95 percent CI 0.41-0.71; P<0.0001), and this improvement in radiologic progression-free survival (rPFS) was consistent across all groups, including high- and low-volume mHSPC patients.

Data analysis of the secondary endpoint of overall survival (OS) also showed a potential survival benefit (HR=0.81, 95 percent CI 0.59-1.12) in the Nubeqa arm compared to placebo. Significant delays in PSA level progression, quality of life deterioration, and time to pain progression were all seen, demonstrating clinically meaningful quality of life improvements. The incidence of Treatment Emergent Adverse Events (TEAEs) remained low, mostly Grade 1 or 2, with no significant differences between treatment arms.

Nubeqa is already approved in the U.S. for treating mHSPC combined with ADT and docetaxel and high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) combined with ADT. The addition of this third indication will provide a new treatment option for elderly or ineligible patients for chemotherapy with Nubeqa.

"The choice of treatment strategy for prostate cancer depends on the time and stage of diagnosis and the patient's systemic status,” said Professor Joung Jae-young, chief of the Center for Urologic Cancer at the National Cancer Center. Nubeqa is the only treatment approved for a three-drug combination with docetaxel and a two-drug combination with ADT alone in patients with hormone-responsive metastatic prostate cancer."

“We look forward to providing patients with a flexible treatment option that can be tailored to their circumstances,” Professor Joung said. “With its favorable tolerability profile, it is a treatment option that can lower treatment burden and positively impact long-term outcomes, and we look forward to rapidly increasing access for patients in Korea.”

Noh Myung-kyu, oncology, pipeline, business development lead at Bayer Korea, said, “Nubeqa has the potential to prolong survival and improve quality of life for patients with hormone-responsive metastatic prostate cancer.”

Noh added that Bayer Korea is committed to bringing this new treatment option to prostate cancer patients and healthcare providers in Korea as quickly as possible.