The Olympus Study (N=71) was a phase 3, open-label, single-arm, multicenter trial in patients with treatment-naïve or recurrent low-grade UTUC with ≥ 1 measurable papillary tumor1,2
Primary endpoint: Complete response (CR)1
Secondary endpoint: Durability of response at 12-month follow-up of CR evaluation2
- CR was defined as a complete absence of tumor lesions in the ipsilateral pyelocalyceal system at 3 months after initiation of Jelmyto by urine cytology, ureteroscopy, and biopsy (if warranted)1
- Patients with larger tumors could have had tumor debulking prior to treatment (37% underwent tumor debulking prior to enrollment)1
- The trial allowed for the instillation of Jelmyto into the pyelocalyceal system via nephrostomy tube or ureteral catheter1
- Patients received Jelmyto once weekly for 6 weeks and, if assessed as a CR, for up to 11 monthly maintenance treatments1
Jelmyto was studied in a broad range of patients with low-grade UTUC1,2
| Patient Baseline Characteristics In The Olympus Study (N=71) | ||
|---|---|---|
| Male Female | 68% 32% | |
| Age | Median 71 years | Range 42-87 years |
| Number of papillary tumors | Median 2* | Range 1-8 |
| Diameter of largest papillary tumor | Median 8 mm | Range 5-15 mm |
| Debulking prior to enrollment† | 37% | |
| Unresectable tumors at baseline | 48% | |
| Prior history of low-grade UTUC | 52% | |
- Patients enrolled had at least one measurable papillary tumor 5 to ≤ 15 mm1
- The median number of instillations was 6 (range 3-6)1
- During the follow-up period, 29 patients received at least 1 dose of maintenance therapy1
- No data are available in patients with severe renal impairment. Avoid use of Jelmyto in patients with a glomerular filtration rate of < 30 mL/min1
Median number of papillary lesions subsequent to debulking, and prior to treatment, was 1 lesion (range 1-5).1
During the 6 weeks prior to enrollment to meet the inclusioncriteria.1
