Dr. Haag-Molkenteller on implications of vibegron phase 3 EMPOWUR extension study

Overactive bladder continues to be a major issue that negatively impacts the quality of life for urologic patients around the globe. Fortunately, the new drug vibegron (Gemtesa) continues to show promise in clinical trials for treatment of this condition.

Results of the recent phase 3 EMPOWUR extension study1 demonstrated efficacy and safety of vibegron in patients who suffer from overactive bladder, reports Cornelia Haag-Molkenteller, MD, PhD. Haag-Molkenteller is a chief medical officer at Urovant Sciences, Inc in Irvine, California.

Please discuss the background of the study.

This is another analysis of our EMPOWUR phase 3 study for vibegron , which is an approved treatment for overactive bladder. The first study results were published in 2019. And then we published several sub analyses, including in elderly patients, which is another very important aspect for overactive bladder. This analysis now combined the objective response of the parameters of overactive bladder as micturition frequency, which means how often you go to the bathroom in 24 hours, urge incontinence and urgency, which is one of the leading symptoms, and the patient response to the treatment. The patient voice is very important as well.

What were the findings of this study? And were any of them surprising to you?

First of all, we were very happy with our efficacy and safety results from the EMPOWUR study with the 75 mg of vibegron . This study, of course, showed and confirmed that the patient also perceives the so-called 'objective treatment effect' of their micturition frequency, urgency, [and] urge continence themselves as an improvement, which I think is very important because next to objective parameters, which you gather on the bladder diary, it's also important to hear the patient's voice—how the individual who is being treated feels about the improvement of their symptoms, and feels about the treatment benefit they're receiving. So, this analysis of this publication confirms the link between efficacy and the patient perception, and that the results are actually meaningful to the patients as well.

How will the results of this study impact your company’s clinical development programs for overactive bladder?

I am a chief medical officer of a pharma company. So, we lead the clinical development of drugs. We will always continue to include the patient's voice in our clinical development programs, which means we will have patient-reported outcomes, [or] PROs, in our clinical studies. The individual patient is very important to us at Urovant. So, how the individual patient responds to treatment is very important, and how they feel about the treatment is very important to us as we develop new drugs.

Is there further research on this topic planned? And if so, what will its focus be?

We will continue to read the patient feedback, and we will even focus more on meaningful patient-reported outcomes where the patient can really voice their opinion with the collection of the study results. We will always have, of course, efficacy and safety in a clinical study, but also the patient’s voice and what the treatment means to the patients or individuals. It’s not one group. It’s an individual person. We really strive to approach them as individuals and keep that in mind when we design our clinical studies because we want the patients to really benefit from the treatment and live their life to their fullest.

What is the take-home message for the practicing urologist?

I think for overactive bladder, the practicing urologist will employ the so-called ‘bladder diary.’ They will collect the objective symptoms, which as I said, were micturition frequency, urge incontinence, and urgency in overactive bladder. However, I do believe that all urologists do listen to their patients. It is important to ask the patient how they feel about the treatment. Do they feel that it really helps them? And when they see the results, of course, that is very important. This combination of the objective parameters of the patient's voice and what the treatment means to the patient is extremely important also for a treating urologist or urogynecologist prescribing medications for overactive bladder.

Is there anything else you feel our audience should know about this topic?

As I said before, integrating the patient's voice and what the treatment means to the patient next to objective parameters for any treatment, I think, is extremely important. Patients are human beings, and they're individuals. We need to understand what the treatment [means] to them as individuals, and how they perceive the benefit of the treatment.

Reference

1. Staskin D, Frankel J, Varano S, et al. Once-daily vibegron 75 mg for overactive bladder: Long-term safety and efficacy from a double-blind extension study of the international phase 3 trial (EMPOWUR). J Urol. 2021 May;205(5):1421-1429. Doi: 10.1097/JU0000000000001574. Epub 2020 December 28.