The future landscape according to urologic oncology experts
November is National Bladder Health Month and a time to reflect on UroGen’s journey to transform care for patients with urothelial cancers. Advances in the treatment of urothelial cancers have been historically limited despite remarkable progress in the collective field of oncology. For decades, patients have received the standard of care, which is often invasive or radical surgery. That is why the Company is striving to fundamentally change how urothelial and other specialty cancers are treated — because patients deserve better options.
Now more than ever, a transformative shift is underway in urology. A shift where urologists are the primary gatekeeper for urologic oncology patients and increasingly prominent in patient care as they embrace therapeutic intervention to enhance patient satisfaction. We are proud to partner in this transformation by offering a novel approach to treatment that is uniquely suited to the ways urologists practice medicine.
For example, UroGen’s innovative RTGel™ technology facilitates extended dwell time of active medicines in areas of the body that are challenging to treat for anatomic or physiologic reasons, such as the kidney or urinary bladder. The Company’s first approved treatment using RTGel has given patients with low-grade upper tract urothelial cancer a chance to avoid radical kidney removal. Now we are developing our technology to address unmet needs in non‑muscle invasive bladder cancer (NMIBC) — including our Phase 3 ENVISION study of UGN-102 and our Phase 1 study of UGN-301.
In honor of Bladder Health Month, I recently discussed the current and future landscape of bladder cancer treatment with two surgeons and urologic oncology experts, Dr. Sam S. Chang (SSC), Vanderbilt University Medical Center, and Dr. Sia Daneshmand (SD), USC Department of Urology.
LB: What do you think are the unmet needs and challenges facing physicians treating patients with NMIBC?
SSC: Patients with low-grade NMIBC with chronically recurring disease lack alternatives to repetitive endoscopic surgery, which is the current standard of care. For patients with high-grade disease whose tumors do not respond to Bacillus Calmette-Guérin (BCG), we lack good alternatives to radical cystectomy, which is a significant and difficult operation for many patients but currently is the recommended treatment in this situation.
SD: We have mostly relied on BCG and some chemotherapeutic agents, but when they do not work, our current armamentarium is limited. Exciting new therapies are coming down the pipeline, but these are mostly in clinical trials and not commercially available yet. When a patient is not a candidate for a clinical trial, we have limited options to offer other than removing the bladder. So, one challenge is getting patients into a trial; another is if the trial does not work, oftentimes patients are ineligible to participate in another trial, because too much time has passed since diagnosis.
LB: What would you like to see become available for your patients with NMIBC across the disease spectrum?
SSC: A non-invasive, durable treatment option to combat disease recurrence in patients with low-grade intermediate risk disease could greatly reduce the burden of repetitive surgery. In addition, due to the inconsistent supply of BCG, it would be ideal if we could offer patients with high risk disease an alternative to BCG. Overall, urologists are seeking alternatives that offer robust efficacy, local delivery that avoids systemic side effects, and proven safety for patients.
SD: Novel drug delivery mechanisms are being tested that challenge the ways NMIBC has been traditionally treated. Topical agents and drug eluting types of devices that are placed in the bladder deliver medicine differently than we are used to with even older agents being revived. I think these are exciting concepts and we can test different compounds within the bladder to see if there is increased efficacy with increased dwell time.
LB: Would an intravesical approach and local delivery of a combination of immunomodulators to treat bladder cancer provide any advantages? How would this fit into the treatment paradigm?
SSC: A potent combination that is tolerated and shown to be effective could be very attractive. For patients with intermediate or high risk NMIBC, if we can determine upfront who may be most effectively treated by certain medications, and if we can get an early signal of whether that medication is working, that would be truly beneficial. In addition, for many treatments, we have advocated maintenance therapy. Again, if we can determine upfront who may be most effectively treated with continued therapy, and then can tailor duration of maintenance therapy, then we are talking about significant improvement of care.
SD: BCG is one of the oldest known immunotherapy drugs used to treat patients for any disease, so based on that premise, the short answer is yes, but it’s complicated. In one previous trial we did not see the benefit of topical immunotherapy for NMIBC, but fortunately the research does not stop there. I think there is a future, particularly if we find the right combination of drugs, something that is cytotoxic and has an immunomodulatory effect, where we are targeting the cancer cells from two different angles.
LB: National Bladder Health Month is an important time to reflect on the standard of care for bladder cancer and consider how we can address unmet needs to improve patient care, because patients deserve better options. As a change agent in urologic oncology, UroGen is proud to partner in the transformative shift underway in urology. For more information, please visit our website.
Disclaimer: Drs. Chang and Daneshmand are representing their own views and not necessarily the views of their employer or affiliated institutions. They are paid consultants for UroGen.