Sumitomo Pharma Showcases Urology & Oncology Findings at 2024 AUA Meeting

Sumitomo Pharma America, Inc. (SMPA) has recently disclosed findings from a pivotal Phase 3 clinical trial at the American Urological Association's annual gathering. The study, known as URO-901-3005, investigated the effects of vibegron (GEMTESA®) in men with overactive bladder (OAB) who were concurrently undergoing drug treatment for benign prostatic hyperplasia (BPH). The trial was a double-blind, placebo-controlled effort that spanned 24 weeks and involved nearly 1,100 participants.
The treatment with vibegron at a dosage of 75 mg daily demonstrated significant improvements over the placebo in reducing the frequency of urination and urgency episodes, with the benefits observed as early as the second week and sustained throughout the study duration. Notably, vibegron also achieved all secondary endpoints, showing marked reductions in daily nocturia episodes, urge urinary incontinence, and the international prostate symptom score (IPSS)-storage score. Additionally, there was a substantial increase in the volume voided per urination compared to the placebo group. The medication was found to be well-tolerated, with a safety profile on par with the placebo, and no new safety concerns were raised.
Janet Owens-Grillo, Ph.D., M.S., who is the Executive Director of Clinical Research at SMPA, emphasized the importance of these findings, stating that there is currently no approved treatment for OAB symptoms in men undergoing BPH treatment. The study also evaluated the impact on quality of life using the OAB questionnaire, which revealed significant improvements with vibegron treatment at both the 12th and 24th week marks.
While vibegron has not yet been approved for use in men with OAB receiving BPH pharmacological therapy, the data presented at the AUA meeting contributes to the growing evidence base for its potential application. Additionally, SMPA, in collaboration with Pfizer, presented a poster discussing patient preferences for oral versus injectable androgen deprivation therapy (ADT) for advanced prostate cancer, indicating a preference for oral treatments.
Adele Gulfo, CEO of the Biopharma Commercial Unit at SMPA, highlighted the company's dedication to advancing scientific and therapeutic solutions for patients with unmet needs. Vibegron, a beta-3 adrenergic receptor agonist, is being investigated in the U.S. for the treatment of OAB symptoms in men receiving BPH therapy. It has been used to treat OAB symptoms, including urinary incontinence, urgency, and frequency, since April 2021. The medication operates by targeting β3 receptors to alleviate symptoms and increase bladder capacity.
OAB affects approximately 33 million adults in the U.S. and is characterized by involuntary bladder contractions, leading to urgent and frequent urination. BPH, affecting a significant portion of aging men, is associated with an enlarged prostate and can cause lower urinary tract symptoms (LUTS), which may overlap with OAB symptoms. The safety information for GEMTESA notes that urinary retention has been reported with its use, and caution is advised for patients with bladder outlet obstruction or those on certain medications.
Sumitomo Pharma Co., Ltd., the parent company of SMPA, is a leading global pharmaceutical firm with a broad focus on various medical areas, including oncology, urology, and cell and gene therapies. The company is committed to accelerating the development of innovative treatments to address pressing patient needs.