Chemoablate now to deliver a complete response, while sparing the kidney for tomorrow1*
Dichotomous primary endpoint:
Complete response (CR) vs no CR2
0%
of patients achieved CR
with Jelmyto†
N=71 (95% CI: 45, 69)
- As OLYMPUS was a single-arm trial intended to demonstrate the effect of chemoablation, patients had to have a remaining index lesion for inclusion criteria1
- Patients had treatment-naïve or recurrent low-grade noninvasive UTUC with at least one measurable papillary tumor 5 to ≤ 15 mm1
Prespecified subgroup analysis: Patients with unresectable tumors3
- 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)
JELMYTO is instilled via the pyelocalyceal system in a procedure that spares the kidney.
Forty-two patients achieved CR at primary disease evaluation; however, one patient withdrew consent.3
Emergence of high-grade disease (not detected at baseline).2
Defined as any increase in tumor size or number that was not a complete response.3
In patients with low-grade UTUC,
Complete response with JELMYTO has proven durable over time1,4
Duration of response (DoR) was assessed at 12 months
Olympus Study1
- 23 (56%) patients remained in CR
- 8 patients had disease recurrence
- 10 patients were inevaluable
Median DoR was not reached (range 0-18.8+ months)
A separate noninterventional study4
Long-term outcomes in eligible patients previously enrolled in the Olympus Study
Long-term follow-up study||
In a subset of 16 patients who had previously achieved CR at the Olympus 12-month assessment
- 29 months median DoR (range 14.6-47.6 months)
- 81% (n=13/16) continued CR beyond 12 months
- 2 patients had a recurrence
- 1 patient had an RNU following ureteral stricture
Long-term follow-up study: Interim results from an ongoing rollover study. The primary objective was to obtain long-term results from participating patients in the Olympus Study, including those who had achieved CR at the 12-month assessment of durability. This study is in accordance with UroGen's postmarketing commitment to provide annual updates for consenting patients with ongoing CR who were enrolled in the Olympus Study.4
The limitations of this study and the DoR analysis include the following: (1) The sample size of the subpopulation for the DoR analysis was small (n=16); (2) This study did not enroll nor follow 7 of the 23 patients (30%) who had remained in CR at the end of the OLYMPUS Study; (3) The methodology for evaluating patient outcomes differed from the one used in the Olympus trial.4
RNU = radical nephroureterectomy.
