Clinicians may soon have a new non-surgical approach to offer patients with low-grade upper tract urothelial cancer (UTUC).
Researchers presented findings at the AUA annual meeting in San Francisco demonstrating that UGN-101 (MitoGel), an investigational mitomycin formulation, may be a new non-surgical treatment option for patients with UTUC. The interim analysis from the ongoing international multicenter phase III OLYMPUS clinical trial showed a complete response rate of 59% in 34 patients who were evaluated for primary disease evaluation (PDE), which was the primary endpoint. PDE involves the use of ureteroscopy and wash cytology.
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PDE was conducted 4 to 6 weeks after completion of UGN-101 treatment, which was administered once weekly for 6 weeks. The authors found that 20 of the interim analysis intent-to-treat population achieved a complete response, which was defined as a negative ureteroscopic evaluation and a negative wash cytology. In addition, five of 34 patients (15%) achieved a partial response.
“The complete responses have been durable at 3-month follow-up, 6 months, and 9 months. The high initial complete response rate and durability observed in the interim analysis is very promising and suggests that UGN-101 could be an effective and well-tolerated noninvasive treatment for patients with UTUC, potentially sparing them from invasive surgery to remove their kidney,” said principal study investigator Seth Paul Lerner, MD, of Baylor College of Medicine, Houston.
In this current investigation, approximately 39% of tumors treated were categorized as unresectable by surgery at baseline. Among the 20 patients who achieved a complete response, 13 patients have reached 3-month follow-up and all remain in complete response. Four of these 13 patients have reached 6-month follow-up and one of the 13 patients has reached 9-month follow-up. All remain in complete response.