Dr McKay on Real-World QOL and Safety Outcomes With Relugolix in Advanced Prostate Cancer

“In summary, we did not identify any new safety signals, we did not see any decrement in QOL, and we demonstrated high adherence with real-world use of relugolix.”

Rana R. McKay, MD, a professor in the Department of Medicine and the Department of Urology at UC San Diego School of Medicine, discussed data from the phase 4 OPTYX trial (NCT05467176) of real-world relugolix (Orgovyx) in patients with advanced prostate cancer.

Findings from OPTYX presented in a poster during the 2026 Genitourinary Cancers Symposium revealed that patient quality of life scores as assessed by the Functional Assessment of Cancer Therapy–Prostate (FACT-P) scale were high at baseline and remained stable across the first 6 months of the study, McKay began. Additionally, FACT-P domain scores, including physical, social/family, functional, and emotional well-being, also remained stable, as did the prostate cancer subscale score, she added. This trend was observed regardless of whether relugolix was given as monotherapy or in combination with systemic therapies, she noted.

Treatment with relugolix as monotherapy or a combination component also led to high adherence rates, McKay explained. The treatment adherence rates were 95.7% in the monotherapy cohort (n = 509) and 96.3% in the combination arm (n = 108), she reported. Moreover, no new safety signals were identified with relugolix, McKay said. In the overall cohort (n = 999), serious adverse effects (SAEs) occurred at a rate of 3.9%. The most common SAEs included anemia (0.4%) and acute myocardial infarction (0.3%).

Disclosures: McKay holds consulting or advisory roles with Ambrx, Arcus Biosciences, Astellas Medivation, AstraZeneca, AVEO, Bayer, Blue Earth Diagnostics, Bristol Myers Squibb, Calithera Biosciences, Caris Life Sciences, Daiichi Sankyo, Dendreon, Esiai, Exelixis, Janssen, Lilly, Merck, Myovant Sciences, NeoMorph, Novartis, Pfizer, Precede Bio, Sanofi, Seagen, Sorrento Therapeutics, Sumitomo Pharma Oncology, Telix Pharmaceuticals, Tempus, and Vividion Therapeutics. She also received research funding from Artera (Inst), AstraZeneca (Inst), Bayer (Inst), Bristol Myers Squibb (Inst), Exelixis (Inst), Oncternal Therapeutics (Inst), and Tempus (Inst).