-No RFS difference based on use of JELMYTO for primary
chemoablation versus post-endoscopic ablation as adjuvant
therapy
-No RFS difference based on tumor size, location, number of
tumors or route of administration
-Maintenance treatment in a small group linked to higher RFS
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing innovative solutions that treat
urothelial and specialty cancers, today highlights results from a
study on the durability of response from the first and largest
post-commercialization study of JELMYTO® (mitomycin) for
pyelocalyceal solution. The long-term study evaluated 56 patients
who achieved complete response after treatment with JELMYTO from 15
high-volume academic and community centers and helps characterize
how urologists are now using JELMYTO in their practices. This
long-term study titled, “Durability of Response of UGN-101:
Longitudinal Follow-Up of Multicenter Study,” is published online
in Urologic Oncology: Seminars and Investigations.
"The three-year durability data from this study further validate
the potential of JELMYTO in providing long-term disease control for
patients with low-grade upper tract urothelial cancer,” said
Solomon L. Woldu, MD, Assistant Professor of Urology, UT
Southwestern Medical Center, Dallas, Texas, and study investigator.
“Notably, we found that recurrence-free survival was not influenced
by factors like tumor size or location, highlighting the broad
applicability of this treatment. The potential benefits of
maintenance therapy are encouraging, and further research will be
key in confirming its role in improving outcomes for these
patients.”
In this study on durability of response, 68% of patients with
LG-UTUC who initially responded to JELMYTO had no evidence of
disease recurrence at 3 years, as evaluated via endoscopy. The
median follow-up was 23.5 months. RFS did not vary significantly
based on use of JELMYTO for chemoablative versus adjuvant intent,
tumor location (pyelocalyceal versus ureteral), tumor size before
induction, single versus multiple tumors, or JELMYTO administration
route (antegrade versus retrograde). The administration of
maintenance treatment did appear to be associated with
significantly better RFS, however, only 15 patients received
maintenance therapy and, according to the authors, further study is
required to determine the value of maintenance treatments.
"We are excited by the three-year results showing the durability
of JELMYTO in treating low-grade upper tract urothelial cancer,
with 68% of patients remaining recurrence-free,” said Mark
Schoenberg, M.D., Chief Medical Officer, UroGen. “These findings
underscore the promising long-term potential of JELMYTO in managing
this challenging disease. We are committed to improving the lives
of patients with urothelial cancer and advancing our mission to
deliver breakthrough therapies that transform the standard of care
for patients with complex urological conditions."
The limitations of this study include the retrospective design,
lack of a control group, and the lack of a centralized pathology
review. Further study is needed to better understand the long-term
outcomes of JELMYTO and the risks/benefits of maintenance therapy
in this setting. In the phase 3 OLYMPUS study, the safety and
efficacy of JELMYTO was not investigated in the adjuvant setting
(although tumor debulking was permitted prior to study entry),
patients with ureteral tumors and tumors larger than 15 mm were
excluded, administration was limited to the retrograde technique,
and complete response to treatment was assessed via urine cytology,
ureteroscopy and biopsy (when warranted). Due to the risks
associated with JELMYTO treatment following endoscopic ablation of
UTUC or following placement of a nephrostomy tube for JELMYTO
instillation (antegrade administration), an appropriate time
interval consistent with institutional guidelines and standard
medical practice should precede treatment with JELMYTO.
About JELMYTO
JELMYTO® (mitomycin) for pyelocalyceal solution is a
mitomycin-containing reverse thermal gel containing 4 mg mitomycin
per mL gel approved for the treatment of adult patients with
low-grade-UTUC (LG-UTUC). JELMYTO is a viscous liquid when cooled
and becomes a semi-solid gel at body temperature. The drug slowly
dissolves over four to six hours after instillation and is removed
from the urinary tract by normal urine flow and voiding. It is
approved for administration in a retrograde manner via ureteral
catheter or antegrade through a nephrostomy tube. The delivery
system allows the initial liquid to coat and conform to the upper
urinary tract anatomy. The eventual semisolid gel allows for
chemoablative therapy to remain in the collecting system for four
to six hours without immediately being diluted or washed away by
urine flow.
About Upper Tract Urothelial Cancer (UTUC)
Urothelial cancer is the ninth most common cancer globally and
the eighth most lethal neoplasm in men in the U.S. Between five
percent and ten percent of primary urothelial cancers originate in
the ureter or renal pelvis and are collectively referred to as
UTUC. In the U.S., there are approximately 6,000 - 7,000 new or
recurrent LG-UTUC patients annually. Most cases are diagnosed in
patients over 70 years old, and these older patients often have
multiple comorbidities. There are limited treatment options for
UTUC, with the most common being endoscopic surgery or
nephroureterectomy (removal of the entire kidney and ureter).
Treatment with endoscopic surgery can be associated with a high
rate of recurrence and relapse.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and
commercializing innovative solutions that treat urothelial and
specialty cancers because patients deserve better options. UroGen
has developed RTGel® reverse-thermal hydrogel, a proprietary
sustained-release, hydrogel-based platform technology that has the
potential to improve the therapeutic profiles of existing drugs.
UroGen’s sustained release technology is designed to enable longer
exposure of the urinary tract tissue to medications, making local
therapy a potentially more effective treatment option. Our first
product to treat LG-UTUC and investigational treatment UGN-102
(mitomycin) for intravesical solution for patients with low-grade
non-muscle invasive bladder cancer are designed to ablate tumors by
non-surgical means. UroGen is headquartered in Princeton, NJ with
operations in Israel. Visit www.urogen.com to learn more or follow
us on X (Twitter), @UroGenPharma.
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: urinary
tract infection, blood in your urine, side pain, nausea, trouble
with urination, kidney problems, vomiting, tiredness, stomach
(abdomen) pain.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1800FDA1088. You may also report side effects to UroGen
Pharma at 1-855-987-6436.
Please see JELMYTO Full Prescribing Information, including
the Patient Information, for additional information.
Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995, including, without limitation, statements regarding the
potential benefits of JELMYTO in providing long-term disease
control for patients with LG-UTUC; the potential benefits of
maintenance therapy; the estimated patient population and
demographics for UTUC; the potential of UroGen’s proprietary RTGel
technology to improve therapeutic profiles of existing drugs; and
UroGen’s sustained release technology making local delivery
potentially more effective as compared to other treatment options.
These statements are subject to a number of risks, uncertainties
and assumptions, including, but not limited to: prior results may
not be indicative of results that may be observed in the future;
potential safety and other complications from JELMYTO use in
diverse UTUC patient types; and UroGen’s RTGel technology may not
perform as expected and we may not successfully develop and receive
regulatory approval of any other product that incorporates UroGen’s
RTGel technology. In light of these risks and uncertainties, and
other risks and uncertainties that are described in the Risk
Factors section of UroGen’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2024, filed with the SEC on November 6,
2024 (which is available at http://www.sec.gov), the events and
circumstances discussed in such forward-looking statements may not
occur, and UroGen’s actual results could differ materially and
adversely from those anticipated or implied thereby. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to UroGen as of the
date of this release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250122030643/en/
INVESTOR CONTACT: Vincent Perrone Senior Director,
Investor Relations vincent.perrone@urogen.com
609-460-3588 ext. 1093
MEDIA CONTACT: Cindy Romano Director, Corporate
Communications cindy.romano@urogen.com 609-460-3583
ext. 1083
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