AUA 2019: OLYMPUS Trial Assesses Mitomycin Gel in Low-Grade Upper Tract Urothelial Carcinoma


Key Points

  • 71 patients had undergone primary disease evaluation at the time of the analysis, and 41 of the 71 patients (60%) achieved a complete response.
  • Of the evaluated complete responses to date, 27 patients have undergone a 6-month evaluation, and 24 of 27 patients (89%) have remained disease-free at 6 months.
  • 3 of 41 patients who achieved a complete response have relapsed at any time during the study.

Findings from a secondary analysis of the phase III OLYMPUS trial were presented by Kleinmann et al during the Plenary Session at the 2019 American Urological Association (AUA) Annual Meeting (Abstract LBA-16). Results showed that instillation of UGN-101, an investigational formulation of mitomycin gel, produced a 60% complete response rate in a subset of patients with endoscopically unresectable low-grade upper tract urothelial cancer.

Utilizing the RTGel technology platform, a sustained-release, hydrogel-based formulation, UGN-101 is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by nonsurgical means. UGN-101 is delivered to patients using standard ureteral catheters.

About the OLYMPUS Trial

OLYMPUS (Optimized DeLivery of Mitomycin for Primary UTUC Study) is a pivotal, open-label, single-arm phase III clinical trial of UGN-101 for instillation to evaluate the safety, tolerability, and tumor-ablative effect of UGN-101 in patients with low-grade upper tract urothelial cancer. The trial enrolled 71 patients at clinical sites across the United States and Israel.

Study participants were treated with six weekly instillations of UGN-101 administered via a standard catheter. Four to six weeks following the last instillation, patients underwent a primary disease evaluation to determine response, the primary endpoint of the study. Primary disease evaluation involved a ureteroscopy and wash cytology, a standard microscopic test of cells obtained from the urine to detect cancer. Patients who achieved a complete response at the point of primary disease evaluation were then followed for up to 12 months to determine the durability of disease control with UGN-101.

Analysis Results

The analysis showed that in the OLYMPUS intent-to-treat population, 41 of the 68 patients for whom primary disease evaluation data are currently available (60%) achieved a complete response. Overall, 3 of 41 patients who achieved a complete response have relapsed at any time during the study (1 at 3 months following primary disease evaluation, and 2 at 9 months); 2 of these patients were considered unresectable prior to UGN-101 treatment. 

Of the 68 patients, 33 (48.5%) were initially characterized by the treating physician as having endoscopically unresectable tumor at baseline, and 19 (58%) achieved a complete response at the primary disease evaluation. The most common adverse events observed were urinary tract infection, ureteral narrowing, and stricture formation. The majority of ureteral events were reported as mild to moderate and have resolved.

The authors concluded, “Data from the OLYMPUS trial suggest that a minimally invasive chemoablation approach utilizing UGN-101 in this population results in a high rate of initial disease eradication, obviating the need for kidney removal in nearly half of treated individuals. Follow-up to ascertain the durability of complete response in this population is ongoing.”

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