Sumitomo Pharma Presents Urology and Oncology Data at AUA 2024 Annual Meeting

–Data includes results from Phase 3 study of vibegron 75mg (GEMTESA) in men living with overactive bladder receiving pharmacological treatment for benign prostatic hyperplasia–

MARLBOROUGH, Mass., May 7, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc., (SMPA) today announced the presentation of data from URO-901-3005, a Phase 3 randomized, double-blind, parallel-group, fixed-dose study evaluating the efficacy, safety, and tolerability of vibegron (GEMTESA^®) versus placebo over 24 weeks in men living with overactive bladder (OAB) and receiving pharmacological therapy for benign prostatic hyperplasia (BPH) at the American Urological Association (AUA) Annual Meeting. Following the podium presentation at AUA, these results were published in Journal of Urology.

Approximately 1,100 men with OAB symptoms receiving pharmacological therapy for BPH participated in URO-901-3005. The results found that treatment with vibegron (75 mg a day) was associated with statistically significant, clinically meaningful improvements in all co-primary and secondary endpoints. At Week 12, statistically significant reductions were observed from baseline (least squares means) in the average number of micturition (urination) episodes per day (-2.04 [SE: 0.109]; p<0.0001) and in the average number of daily urgency episodes  (-2.88 [SE: 0.164]; p<0.0001) compared to placebo (-1.30 [SE: 0.109] and -1.93 [SE: 0.164], respectively). Improvements in co-primary efficacy parameters were observed by Week 2 and maintained through Week 24 of the trial.

Vibegron met all secondary endpoints at Week 12, including significant reductions versus placebo across secondary endpoints including daily nocturia episodes (-0.88 compared to -0.66; p=0.0015), urge urinary incontinence (UUI) episodes (-2.19 compared to -1.39; p=0.0034) and international prostate symptom score (IPSS)-storage score (-3.0 compared to -2.1; p<0.0001), and a significant increase versus placebo in volume voided per micturition (25.63 mL compared to 10.56 mL; p<0.0001). Once daily 75 mg vibegron was well-tolerated throughout the study and demonstrated a consistent safety profile, that was comparable to placebo, with no new safety signals compared to prior OAB studies.

"The results from the Phase 3 study build on the body of evidence we have outlining the safety, efficacy and tolerability of vibegron as a treatment of the symptoms associated with OAB and now for men receiving pharmacological treatments for benign prostatic hyperplasia experiencing symptoms of OAB," said Janet Owens-Grillo, Ph.D., M.S., Executive Director, Clinical Research at SMPA. "There is currently no approved treatment for persistent OAB symptoms in men who are receiving treatment for BPH. We are happy to share these results with the scientific community at AUA."

Quality of life was assessed during the Phase 3 study via the overactive bladder questionnaire (OAB-q) long form, comprising the symptom bother subscale score and the HRQL total score (including coping, concern, sleep, and social interaction subscores), with 1-week recall. Results presented indicated that vibegron was associated with significant improvements from baseline in OAB-q scores versus placebo at Week 12 and Week 24 (P<0.0001). 

Use of GEMTESA^® (vibegron) in men with symptoms of OAB receiving pharmacological therapy for BPH is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

SMPA also co-presented, in alliance with Pfizer, a poster on the results of a discrete choice experiment looking at whether patients with advanced prostate cancer had a preference between oral and injectable androgen deprivation therapy (ADT). The results suggest that patients are amenable to an oral option, irrespective of prior experience with injectable alternatives. The findings highlight the need for further education on different treatment options, as well as bidirectional communication between patients and providers to determine the best option for each patient.

"SMPA is committed to scientific and therapeutic advancements on behalf of patients where limited or no options exist," said Adele Gulfo, Chief Executive Officer, Biopharma Commercial Unit at SMPA. "We are proud to have our urology and oncology teams together and among the leaders at AUA sharing positive data that underpins our steadfast commitment to those living with unmet urological conditions."

About GEMTESA (vibegron)
Vibegron, a once-daily beta-3 adrenergic receptor (β3) agonist, is currently under investigation for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia in the United States (U.S.). In the U.S., GEMTESA (vibegron) has been indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since April 2021. GEMTESA works by selectively targeting β3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity. In China, vibegron is currently under investigation in a Phase 3 clinical study for the treatment of OAB.

About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours).¹ About 33 million U.S. adults experience the bothersome symptoms of OAB.²

About Benign Prostatic Hyperplasia 
Benign prostatic hyperplasia (BPH) is a condition in men in which the prostate gland is enlarged. About 60% of men with BPH are treated for lower urinary tract symptoms (LUTS).^3,4 LUTS can be divided into storage, voiding, and postmicturition symptoms.⁵ Over half of men with BPH report storage symptoms and about a quarter report voiding symptoms.⁴ This suggests that many men with a diagnosis of BPH may have overactive bladder.⁴ Many men who are treated for symptoms are assumed to have an obstruction in the bladder caused by an enlarged prostate.^3,4 About half of all men between ages 51 and 60 have BPH and up to 90% of men over age 80 are living with the condition.⁶

INDICATIONS AND USAGE
GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product.

WARNINGS AND PRECAUTIONS
Urinary Retention
Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

ADVERSE REACTIONS
Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

Please see full Prescribing Information.

About Sumitomo Pharma 
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information, please visit https://www.us.sumitomo-pharma.com and follow us on LinkedIn.

SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license.
Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd.
GEMTESA is a trademark of Urovant Sciences GmbH, and registered in the U.S., and in other countries.

© 2024 Sumitomo Pharma America, Inc. All rights reserved.

References

1. Overactive bladder – symptoms and causes. Mayo Clinic. 2022. Accessed August 25, 2023. https://www.mayoclinic.org/diseases-conditions/overactive-bladder/symptoms-causes/syc-20355715
2. Gomelsky A. Update on the management of overactive bladder: patient considerations and adherence. Journal of Urology. Open Access J Urol. 2011; 3: 7–17. Published online 2010 Dec 30. doi: 10.2147/OAJU.S7233
3. Burnett AL, Walker DR, Feng Q, Johnston KM, Lozano-Ortega G, Nimke D, Hairston JC. Undertreatment of overactive bladder among men with lower urinary tract symptoms in the United States: A retrospective observational study. Neurourol Urodyn. 2020 Jun;39(5):1378-1386. doi: 10.1002/nau.24348. Epub 2020 May 8. PMID: 32383533; PMCID: PMC7384148.
4. Anger, JT, Goldman, HB, Luo, X, et al. Patterns of medical management of overactive bladder (OAB) and benign prostatic hyperplasia (BPH) in the United States. Neurourology and Urodynamics. 2018; 37: 213–222. https://doi.org/10.1002/nau.23276
5. Lepor H. Pathophysiology of lower urinary tract symptoms in the aging male population. Rev Urol. 2005;7 Suppl 7(Suppl 7):S3-S11. PMID: 16986059; PMCID: PMC1477625.
6. Benign Prostatic Hyperplasia (BPH). Urology Care Foundation. 2021. Accessed August 25, 2023. https://www.urologyhealth.org/urology-a-z/b/benign-prostatic-hyperplasia-(bph)

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