In patients with low-grade UTUC

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

58% N=71 (95% CI: 45, 69)
84% (95% CI: 71, 97) Durability of Response. Estimated probability by KM analysis that a patient will remain in CR for 12 months<sup>2,3</sup>
    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 this 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)

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

SCREENINGTREATMENTFOLLOW-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%
AgeMedian 71 yearsRange 42-87 years
Number of papillary tumorsMedian 2Range 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 tumors

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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