In patients with low-grade UTUC
Chemoablate with Jelmyto to deliver a complete response, while sparing the kidney for tomorrow1*
At the 12-month assessment of durability (n=41)1:
- 23 patients remained in CR
- 8 patients had disease recurrence
- 10 patients were inevaluable
- Median duration of response was not reached, with a range of 0 - 18.8+ months1
- Patients had treatment-naïve or recurrent low-grade non-invasive UTUC with at least one measurable papillary tumor 5 to ≤ 15 mm1
- Kaplan-Meier analysis estimates probability of durable response. It does not represent an actual percentage of patients. In the Olympus trial, at the time of the 12-month assessment for durability, not all patients had a recurrence (patients may have still been in CR, died, or discontinued). The KM analysis accounts for these missing data. The analysis has potential limitations: the sample size was small (n=41) and median duration of response was not reached due to the limited number of recurrences (n=8); this may be reflective of a short follow-up time (12 months)1
Prespecified subgroup analysis: patients with unresectable tumors
- Nearly half (48%) of patients in the Olympus Study had endoscopically unresectable tumors, and the rate of complete response was similar among this subgroup (n=20/34)2
*Jelmyto is instilled via the pyelocalyceal system in a procedure that spares the kidney.
CI=confidence interval; KM=Kaplan-Meier analysis.
Study Design
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
| SCREENING | TREATMENT | FOLLOW-UP (POST-TREATMENT MAINTENANCE AND EVALUATION) | |||
|---|---|---|---|---|---|
6 once-weekly treatments | Post-treatment evaluation | 6 months | 12 months | ||
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 ureteral catheter or nephrostomy tube1
- Patients received Jelmyto once weekly for 6 weeks and, if assessed as a CR, for up to 11 monthly maintenance treatments1
Patient Characteristics
Jelmyto was studied in patients with varied baseline characteristics1,3
| 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 |
| 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
Every patient deserves a chance to spare their kidney for tomorrow
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
NCCN Guidelines® for Upper GU Tract Tumors
National Comprehensive Cancer Network® (NCCN®) recommends mitomycin for pyelocalyceal solution (JELMYTO) following complete or near complete endoscopic resection as a primary therapy option for upper tract tumors4§
Most suitably indicated for4:
a residual, low-grade, low volume (5-15 mm), solitary tumor in the upper urinary tract
a patient not a candidate for or not seeking nephroureterectomy as a definitive treatment
Mitomycin for pyelocalyceal solution may be administered via ureteral catheter or a nephrostomy tube. Complete or near complete endoscopic resection or ablation is recommended prior to mitomycin ureteral gel application.
