Rana R. McKay, MD, discusses data from the phase 4 OPTYX study of real-world relugolix in prostate cancer.
Patients with advanced prostate cancer who were treated with relugolix (Orgovyx) in the real-world setting experienced stable quality of life (QOL), low rates of serious adverse effects (SAEs), and high treatment adherence, supporting the use of the agent in this setting, according to Rana R. McKay, MD.
Findings from the observational phase 4 OPTYX study (NCT05467176) presented in a poster during the
“We’re continuing to dissect the utilization of relugolix and looking at recovery times, long-term utilization, and long-term outcomes,” McKay, a professor in the Department of Medicine and the Department of Urology at UC San Diego School of Medicine in California, said an interview with OncLive®. “Additional analyses will be conducted from the OPTYX trial. We’re going to learn a lot from this study. Almost 1000 patients were enrolled and [we will] continue to analyze the data.”
In the interview, McKay discussed the background of OPTYX, unpacked the key findings from the study, and explained how these data can inform real-world use of relugolix.
McKay: Androgen deprivation therapy [ADT] is a key treatment in the management of prostate cancer. Oftentimes, ADT is used in combination with other therapies, including next-generation hormonal agents.
Relugolix is a gonadotropin-releasing hormone [GnRH] receptor antagonist, and it’s an oral ADT that’s approved by the FDA for the treatment of patients with advanced prostate cancer.2 It’s the only oral approved GnRH analog. In the phase 3 HERO trial [NCT03085095], relugolix was associated with more rapid and sustained testosterone suppression and was generally safe and well tolerated. It was also associated with more rapid testosterone recovery upon discontinuation and potentially improved cardiovascular outcomes. To supplement those clinical trial data, relugolix is being investigated in the phase 4 OPTYX trial.
[OPTYX] is a prospective, multicenter observational study of patients [in the United States] with prostate cancer in the real-world setting. Patients were eligible if they were starting on a new course of relugolix with an intended treatment duration of at least 4 months. [This study aimed] to help bridge the gap from what was reported in HERO to [the] real world.
The data that were presented at ASCO GU focused on QOL, which was assessed through FACT-P, as well as adherence. Patients completed these questionnaires monthly. We also assessed safety through SAE reporting, treatment discontinuation, and deaths.
A total of 999 patients were enrolled on the trial, and at the time of the last data cutoff, 575 remained on treatment. At baseline, 844 patients initiated relugolix monotherapy, and just over 150 initiated relugolix in combination with other treatments. The baseline characteristics of patients enrolled in OPTYX were consistent with real-world patient populations.
We found that QOL scores, as assessed by FACT-P, were relatively high at baseline and remained stable across the first 6 months of the study. Similarly, FACT-P domain scores, including physical, social/family, functional, and emotional well-being, also remained stable, as did the prostate cancer subscale score. This was observed regardless of whether relugolix was given as monotherapy or in combination with systemic therapies.
We also reported high adherence rates. [The treatment adherence rates were] nearly 96% for patients receiving monotherapy and just over 96% for those receiving combination therapy. 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.
One of the biggest questions with the first oral GnRH analog was whether patients would stay on therapy if they were taking an oral medication at home vs coming into the clinic for injections.
We demonstrated that patients are able to adhere to treatment. We also did not identify any increase in adverse effects or SAEs, and QOL remained high throughout treatment. These are all very practical considerations that support the use of relugolix in real-world clinical practice.
