- 60% Complete Response Rate after JELMYTO Induction
- 25% of Patients Received a Ureteral Stent
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing novel solutions that treat
urothelial and specialty cancers, today highlights the results of a
sub-analysis from a real-world patient cohort review of JELMYTO
(mitomycin) for pyelocalyceal solution presented at the American
Urological Association Meeting 2024 in San Antonio, TX. The study
includes a stepwise approach to retrograde administration of
JELMYTO and reports that retrograde administration of JELMYTO in
the clinic (n=20) produced a 60% complete response rate in patients
and ureteral stents were placed in 25% of patients, which is lower
than the rate reported in the pivotal OLYMPUS study.
“The retrograde instillation of JELMYTO for the clinical
management of low-grade upper tract urothelial cancer is
FDA-approved and offers a safe and efficacious mode of
administration, and this study in a real-world population adds to
the growing body of evidence supporting retrograde administration
in appropriate patients,” said Khurshid Ridwan Ghani, MBChB, MS,
FRCS, Professor of Urology, Director, Michigan Urological Surgery
Improvement Collaborative. “The stepwise approach outlined in this
study offers valuable insights into achieving positive efficacy and
safety outcomes, in the clinic with the procedure done under local
anesthesia, with notable durability of response observed.”
In the OLYMPUS study all enrolled patients (n=71) received
retrograde administration of JELMYTO. In the OLYMPUS study 58%
(n=41) of patients achieved a complete response, defined as the
absence of tumor lesions 3 months after initiation of JELMYTO
treatment assessed by urine cytology and ureteroscopy. Ureteric
obstruction* was reported in 58% (n=41) of patients treated with
JELMYTO and 88% (n=36) of that subgroup went on to receive ureteral
stent placement. For additional information about the retrograde
administration of JELMYTO, consult the JELMYTO Instructions for
Administration accompanying the Full Prescribing Information.
In this retrospective real-world study, 20 patients with a mean
tumor burden of 1.67 cm received at least one dose of JELMYTO via
the retrograde mode of administration, of which 16 (80%) completed
six instillations. Twelve patients (60%) had a complete response
and seven patients (35%) received at least one dose of monthly
maintenance therapy, of which five demonstrated durability of
response (4 patients remained tumor-free at 14.25-month follow-up
and 1 patient at 24 months). Six patients (30%) had an adverse
event related to the urinary system. Ureteral stents were placed in
five patients for stenosis (25%); of which four were transient,
with no subsequent obstruction. Only one patient (5%) required
permanent stenting. Three patients who were unable to tolerate the
retrograde approach had antegrade administration of JELMYTO via a
nephrostomy tube.
"These findings emphasize the versatility of JELMYTO
administration and also underscore the significance of continuous
research and innovation in elevating treatment standards for
urothelial cancers,” remarked Mark Schoenberg, M.D., Chief Medical
Officer at UroGen.
The limitations of this sub-analysis include the small sample
size, the retrospective design, lack of a control group, and the
lack of a centralized pathology review and standardized
clinicopathologic assessment.
To further explore the full potential of JELMYTO for the
treatment of patients with upper tract urothelial cancers (UTUC),
investigators are in the process of enrolling the prospective and
retrospective uTRACT Registry to capture data in a large-scale,
standardized manner to report further on patient outcomes following
JELMYTO treatment including longitudinal follow-up.
*Includes hydronephrosis, obstructive uropathy, pelvic-ureteric
obstruction, ureteric obstruction, ureteric stenosis, and urinary
tract obstruction.
About JELMYTO
JELMYTO® (mitomycin) for pyelocalyceal solution is a
mitomycin-containing reverse thermal gel containing 4 mg mitomycin
per mL gel indicated 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 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 face
comorbidities. There are limited treatment options for UTUC, with
the most common being endoscopic surgery or nephroureterectomy
(removal of the entire kidney and ureter). These treatments can
lead to 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
results from the real-world study of the retrograde instillation of
JELMYTO enhancing the prospects of favorable patient outcomes; the
enrollment of the prospective and retrospective data from the
uTRACT Patient Registry and plans to analyze and report on such
data; the estimated patient population for UTUC and LG-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: results from the real-world study of
the retrograde instillation of JELMYTO may not be indicative of
results that may be observed in future clinical practice and may
differ from additional analysis of the data from the study or
uTRACT Patient Registry; potential safety and other complications
from JELMYTO use in diverse UTUC patient types; the ability to
maintain regulatory approval; the ability to obtain and maintain
adequate intellectual property rights and adequately protect and
enforce such rights; complications associated with
commercialization activities; UroGen’s RTGel technology may not
perform as expected; and UroGen 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 Annual Report on Form 10-K
for the year ended December 31, 2023, filed with the SEC on March
14, 2024 (which is available at 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/20240504905017/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
UroGen Pharma (NASDAQ:URGN)
過去 株価チャート
から 4 2024 まで 5 2024
UroGen Pharma (NASDAQ:URGN)
過去 株価チャート
から 5 2023 まで 5 2024