Supplements and Featured Publications
Real-world treatment with relugolix maintained QOL outcomes and had a manageable safety profile in patients with advanced prostate cancer.
Treatment with relugolix (Orgovyx), both as monotherapy and as a combination component, in patients with advanced prostate cancer was associated with stable quality of life (QOL), high treatment adherence, and a low rate of serious adverse effects (SAEs) over the first 6 months of therapy, according to findings from the observational phase 4 OPTYX study (NCT05467176) that were presented during the
Data from OPTYX demonstrated that the Functional Assessment of Cancer Therapy–Prostate Criteria (FACT-P) total mean scores among patients who received relugolix monotherapy (n = 844) and combination therapy (n = 155) were maintained over 6 months for patients in both cohorts. The rate of SAEs was 3.9% in the overall population (n = 999), and the incidence of SAEs was generally similar between the monotherapy and combination therapy cohorts. The most common SAEs were anemia (0.4%) and acute myocardial infarction (0.3%).
“Real-world utilization of relugolix was associated with stable QOL, high treatment adherence, and a low rate of reported SAEs over the first 6 months,” Rana R. McKay, MD, a professor in the Department of Medicine and the Department of Urology at UC San Diego School of Medicine in California, and her coauthors wrote in a poster presentation of the data.
OPTYX was a prospective, multicenter, observational study that enrolled adult patients with prostate cancer in the United States who received relugolix as monotherapy or as a combination component.1,3 In order to be eligible for the study, patients needed to have received relugolix at the time of study enrollment or within 1 month prior to enrollment while remaining on treatment at the time of enrollment and be willing to complete patient-reported outcome assessments. Patients who had an intended treatment plan with relugolix of less than 4 months were excluded.
Relugolix combination therapy was defined as receiving the agent plus other systemic therapies, including first- or second-generation androgen pathway inhibitors, chemotherapy, PARP inhibitors, immunotherapy, and/or radiation therapy.
Patients were enrolled in OPTYX from October 3, 2022, to August 21, 2024. Data collection was ongoing in 3- to 6-month intervals until the data cutoff of March 7, 2025. The planned study end date is June 30, 2026.
Patients were assessed for QOL using FACT-P criteria; treatment adherence using the Simplified Medication Adherence Questionnaire (SMAQ); and safety per incidence of SAEs, treatment discontinuation, and death. The FACT-P was completed at baseline as well as at 3 and 6 months.
At baseline, the mean age in the overall population was 70.7 years (SD, 8.40) and most patients were White (77.3%). Disease states at enrollment consisted of local (42.6%), locally advanced (16.5%), biochemical recurrence (11.2%), metastatic castration-sensitive prostate cancer (19.3%), nonmetastatic castration-resistant prostate cancer (CRPC; 1.4%), metastatic CRPC (4.8%), other (2.8%), and unknown (1.3%). Radiotherapy types at enrollment included external beam therapy (27.3%), brachytherapy (0.8%), external beam therapy and brachytherapy (1.8%), and other (3.0%).
In the overall population, 0.5% of patients experienced at least 1 SAE related to a study drug. Discontinuations due to an adverse effect (6.1%) and deaths (0.2%) occurred infrequently. Additional SAEs included cardiac arrest (0.2%), chronic obstructive pulmonary disease (0.2%), and septic shock (0.2%).
In terms of treatment adherence, 95.7% of patients who received relugolix monotherapy and 96.3% who were treated with combination therapy reported always taking relugolix at the appropriate time of day. Patients in the monotherapy and combination cohorts reported discontinuing treatment with relugolix when they felt bad at respective rates of 4.1% and 3.7%. Most patients in both the monotherapy (83.3%) and combination therapy (83.3%) arms reported never forgetting to take relugolix. Overall, 16.9% of patients reported forgetting to take relugolix at least 1 time.
“Patients will continue to be followed for a longer-term analysis in this ongoing study,” McKay and her coauthors wrote in their conclusion.
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).
