Sarah Psutka, MD, on phase 3 trial of padeliporfin VTP therapy in UTUC

In this video, Sarah P. Psutka, MD, MSc, highlights the rationale and design for the phase 3 ENLIGHTED trial, exploring the safety and efficacy of padeliporfin vascular targeted photodynamic therapy (VTP) for patients with low-grade upper tract urothelial carcinoma. The study was highlighted during the Society of Urologic Oncology 25^th Annual Meeting in Dallas, Texas. Psutka is an associate professor of urology at the University of Washington and Fred Hutchinson Cancer Center.

Video Transcript:

ENLIGHTED is a trial that's being run through the SUO CTC. I would just make a plug. I think the CTC is sponsoring—they obviously have been great proponents of the cretostimogene products as well—and the bladder program specifically within the SUO CTC is incredibly strong right now. There's just so many interesting trials that that team of investigators is supporting. On the renal committee, ENLIGHTED is one of our trials. It is a trial looking at a novel therapeutic, the VTP padeliporfin. It's a combination of a medication that is given intravenously during surgery and then light activated with a near infrared laser with the goal of preserving the kidney in the management of low-grade upper tract urothelial carcinoma.

Obviously, upper tract urothelial carcinoma is a relatively less prevalent cancer that we as urological oncologists treat. [In] the low-grade disease space, that is a tumor that is not likely to be life threatening, but can very much be kidney threatening. The idea is that this is a therapeutic that's being looked at as a way of ablating the tumors with the kidney in citu and preserving the kidney. It's a study that's anticipated to enroll about 100 patients. I believe the data here, there's 20 patients who had actually been treated of the 30 or so who had been enrolled at the time when the data was analyzed during the summer. I know, personally, I've actually gotten a few more patients on trial, and the accrual has really been ramping up, which is exciting.

The primary end point is complete response rate, which is assessed at 1 month, 28 days, give or take after the first therapy. Patients can get retreated up to 3 times before they go into a maintenance evaluation plan. The toxicity profile is highlighted in our poster. It's relatively well tolerated. I think there was only 1 grade 3 toxicity, but otherwise, most of the side effects resolve fairly quickly. It's a fairly easy therapy to administer in the operating room. From a technical standpoint, it's actually very easy, because essentially, you're shining the laser at the tumor after administering the medication for about a 10-minute period. Once you have your team trained up on the protocol, it's very straightforward to enact.

I think that patients are enthusiastic about any option that allows them to have their upper tract tumor treated that does not involve the removal of the kidney. This is another therapeutic that adds to UroGen [profile] as a potential treatment that could be used to preserve kidneys while treating low grade upper tract urothelial carcinoma going forward. We're excited to see where it will go. Obviously, we still have a number of patients to accrue and to track the data carefully, but I believe the initial CR that was reported on the poster was about 85%, which is encouraging.

This transcript was AI generated and edited by human editors for clarity.