In patients with low-grade UTUC

Chemoablate with JELMYTO to deliver a complete response, while sparing the kidney for tomorrow1

N=71

58%(95% CI: 45, 69) Complete Response (CR)1

84%(95% CI: 71, 97) Durability of Response estimated based on an interim Kaplan-Meier analysis at 12 months post-CR2,3

    The OLYMPUS Study is ongoing. At the time of data cutoff1:
  • 19 patients remained in CR
  • 7 patients had disease recurrence
  • 9 patients continued to be followed for 12-month duration of response1
  • 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

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=34)2

CI=confidence interval.


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

SCREENINGTREATMENTFOLLOW-UP (POST-TREATMENT THERAPY 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 evaluation1

  • CR was defined as a complete absence of tumor lesions 4-6 weeks after the last instillation via urine cytology, ureteroscopy, and biopsy (if warranted)2
  • Patients with larger tumors could have had tumor debulking prior to treatment (37% underwent tumor debulking prior to enrollment)1
  • JELMYTO was instilled into patients using a catheter inserted via the ureter into the pyelocalyceal system or via 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%
AgeMedian 71 yearsRange 42-87 years
Number of papillary tumorsMedian 2*Range 1-8
Diameter of largest papillary tumorMedian 8 mmRange 5-15 mm
Unresectable tumors at baseline48%
Prior history of low-grade UTUC48%
  • Patients enrolled had at least one measurable papillary tumor between 5–15 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
*Median number of papillary lesions just prior to treatment was 1 lesion (range 1-5).

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:

line-art illustration of residual tumor matter

a residual, low-grade, low volume (5-15 mm), solitary tumor in the upper urinary tract

line-art illustration of two patients -- one with short hair, one with long hair

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.

† Category 2A recommendation. Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate. All recommendations are Category 2A unless otherwise indicated.
‡ See NCCN Guidelines® Bladder Cancer (Version 6.2020) Intrapelvic and Intravesical Therapy for Upper Tract Tumors and NCCN Guidelines for Upper GU Tract Tumors (Version 6.2020) for detailed recommendations.

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