The Olympus Study
a phase 3, open-label, single-arm, multicenter trial in patients with treatment-naïve or recurrent low-grade UPPER TRACT UROTHELIAL CANCER with ≥ 1 measurable papillary tumor (N=71)1,2
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
- 100% of patients in the study received JELMYTO through retrograde instillation2
- The dosage of Jelmyto was individualized based on volumetric measurements using pyelography with the intent to fill the renal pelvis (max dose was 15 mL or 60 mg mitomycin)1
Jelmyto was studied in patients typically seen in a clinical practice1,2
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 1* | Range 1-5 |
Diameter of largest papillary tumor | Median 8 mm | Range 5-15 mm |
Unresectable tumors at baseline | 48% | |
Prior history of low-grade UTUC | 52% |
Both newly diagnosed patients (n=34) and patients with recurrent low-grade upper tract urothelial cancer (n=37) were included in the Olympus Study2
- 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
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