In patients with low-grade UTUC
Chemoablate with JELMYTO to deliver a complete response, while sparing the kidney for tomorrow1
N=71
58%
84%
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
| SCREENING | TREATMENT | FOLLOW-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% | |
| 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 | 48% | |
- 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
Every patient deserves a chance to spare their kidney for tomorrow
Approved Use for JELMYTO
JELMYTO™ is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).
Important Safety Information
You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you
- are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.
Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose. - are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
- Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?
- Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
- You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
- JELMYTO is given to your kidney through a tube called a catheter.
- During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:
- JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
- To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
- Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:
- Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
- Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: side pain, urinary tract infection, blood in your urine, kidney problems, tiredness, nausea, stomach pain, trouble with urination, vomiting, low red blood cell count, frequent urination, itching, chills, and fever.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please click here for JELMYTO Full Prescribing Information, including the Patient Information, for additional information.
Please click here for Full Prescribing Information, Instructions for Pharmacy and Instructions for Administration.