- Kaplan-Meier Estimate of Duration of Response at 12 Months in
Patients Who Achieved a Complete Response at Three Months was 82.3%
(95% CI, 75.9%, 87.1%)
- Side Effect Profile Consistent with Previous Clinical Trials of
UGN-102
- UroGen will Host a Virtual Event Today at 11:00 AM Eastern
Time
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing novel solutions that treat
urothelial and specialty cancers, today announced 82.3% (95% CI,
75.9%, 87.1%) 12-month duration of response (DOR) data by
Kaplan-Meier estimate (n=108) from its Phase 3 ENVISION trial in
patients who achieved complete response (CR) at three months after
the first instillation of investigational drug UGN-102 (mitomycin)
for intravesical solution. The ENVISION trial previously met its
primary endpoint by demonstrating that patients treated with
UGN-102 had a 79.6% (95% CI, 73.9%, 84.5%) CR rate at three months
following the first instillation of UGN-102.
The ENVISION Phase 3 study is investigating UGN-102 in patients
with low-grade intermediate-risk non-muscle invasive bladder cancer
(LG-IR-NMIBC). In addition to the 12-month data, the DOR Kaplan
Meier estimates at 15 (n=43) and 18 (n=9) months were both 80.9%
(95%CI, 73.9%, 86.2%).
“UGN-102 has demonstrated a strong clinical profile across
multiple trials, with these latest results of 79.6% three-month
complete response rate and 82.3% DOR at 12 months reinforcing its
potential to be the first FDA-approved non-surgical option for
treatment of LG-IR-NMIBC,” said Liz Barrett, President and Chief
Executive Officer of UroGen. “We estimate 82,000 patients suffer
from this highly recurrent disease in the U.S. each year and may
benefit from an innovative approach to treating their disease.”
The most common treatment-emergent adverse events (TEAEs) in the
ENVISION trial were dysuria, hematuria, urinary tract infection,
pollakiuria, fatigue, and urinary retention. TEAEs were typically
mild-to-moderate in severity. The ENVISION trial demonstrated a
similar safety profile to that observed in other studies of
UGN-102.
“These DOR findings continue to support the development of
UGN-102 as a non-surgical alternative to the current standard of
care of repeated surgeries for LG-IR-NMIBC, which can impact
patients’ physical health and quality of life,” said Sandip Prasad,
MD, M.Phil., Director of Genitourinary Surgical Oncology,
Morristown Medical Center/Atlantic Health System, NJ. “These
results from the ENVISION study make me very optimistic about the
opportunity for UGN-102, if approved, to provide another option for
patients living with this highly recurrent disease.”
“While LG-IR-NMIBC’s highly recurrent nature often means
patients must undergo numerous surgeries throughout their lifetime,
I am excited about the potential for patients to better manage the
ongoing burden of this disease,” said Mark Schoenberg, M.D., Chief
Medical Officer, UroGen. “UGN-102, if approved, could provide a
minimally invasive option for LG-IR-NMIBC patients whose existing
treatment options currently center around repetitive
surgeries.”
In January 2024, UroGen initiated the submission of a rolling
New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for UGN-102 as a treatment for LG-IR-NMIBC. The latest DOR
data are expected to support the UGN-102 NDA, which the Company
plans to complete in the third quarter of 2024, with a potential
FDA decision as early as the first quarter of 2025.
UGN-102 ENVISION DATA Virtual Event
The Company is hosting a data event featuring a panel discussion
with leading bladder cancer experts today, Thursday, June 13, 2024,
at 11:00 a.m. Eastern Time to discuss results from the Phase 3
ENVISION clinical trial.
Please register for the webinar under the Events &
Presentations section of the Company’s Investor Relations site
(https://investors.urogen.com/events-and-presentations).
Following the live webcast, a replay will be available on the
Company's website (https://urogen.com).
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative
drug formulation of mitomycin, currently in Phase 3 development for
the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel®
technology, a sustained release, hydrogel-based formulation,
UGN-102 is designed to enable longer exposure of bladder tissue to
mitomycin, thereby enabling the treatment of tumors by non-surgical
means. UGN-102 is delivered to patients using a standard urinary
catheter in an outpatient setting by a trained healthcare
professional. UroGen anticipates completing its NDA submission for
UGN-102 in the third quarter of 2024 with a potential FDA decision
as early as the first quarter of 2025.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
In the U.S. bladder cancer is the second most common urologic
cancer in men. LG-IR- NMIBC represents approximately 22,000 newly
diagnosed bladder cancer patients each year and an estimated 60,000
recurrences annually among patients diagnosed from previous years.
Bladder cancer primarily affects older populations with the median
age of diagnosis 73 years and an increased risk of comorbidities.
Guideline recommendations for the management of NMIBC include TURBT
as the standard of care. Up to 70 percent of NMIBC patients
experience at least one recurrence and LG-IR-NMIBC patients are
even more likely to recur and face repeated TURBT procedures.
About ENVISION
The Phase 3 ENVISION trial is a single-arm, multinational,
multicenter study evaluating the efficacy and safety of UGN-102
(mitomycin) for intravesical solution as primary chemoablative
therapy in patients with LG-IR-NMIBC. The Phase 3 ENVISION trial
completed target enrollment with approximately 240 patients across
56 sites. Study participants received six once-weekly intravesical
instillations of UGN-102. The primary endpoint evaluated the CR
rate at the three-month assessment after the first instillation,
and the key secondary endpoint evaluated durability over time in
patients who achieved a CR at the three-month assessment. Based on
discussions with the FDA, UroGen anticipates completing its NDA
submission for UGN-102 in the third quarter of 2024. Learn more
about the Phase 3 ENVISION trial at www.clinicaltrials.gov
(NCT05243550).
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 low-grade upper tract urothelial cancer and
investigational treatment UGN-102 (mitomycin) for intravesical
solution for patients with LG-IR-NMIBC 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.
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 for UGN-102 as the first FDA-approved non-surgical
treatment for LG-IR-NMIBC; the estimated annual U.S. patient
population and demographics for LG-IR-NMIBC; the potential
opportunities for UGN-102, if approved, including to provide a
minimally invasive option for patients with LG-IR-NMIBC and to help
such patients better manage the ongoing burden of the disease;
statements related to UroGen’s planned NDA submission for UGN-102
and the potential timing for a decision from the FDA thereon; 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: the ENVISION DOR data may not be
sufficient to support an NDA submission for UGN-102; even if an NDA
for UGN-102 is accepted by the FDA, there is no guarantee that such
NDA will be sufficient to support approval of UGN-102 on the
timeframe expected, or at all; the ability to obtain regulatory
approval within the timeframe expected, or at all; the ability to
maintain regulatory approval; complications associated with
commercialization activities; the labeling for any approved
product; competition in UroGen’s industry; the scope, progress and
expansion of developing and commercializing UroGen’s product
candidates; the size and growth of the market(s) therefor and the
rate and degree of market acceptance thereof vis-à-vis alternative
therapies; UroGen’s ability to attract or retain key management,
members of the board of directors and other personnel; UroGen’s
RTGel technology may not perform as expected; UroGen may not
successfully develop and receive regulatory approval of any other
product that incorporates RTGel technology; UroGen’s financial
condition and need for additional capital in the future. 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 March 31, 2024,
filed with the SEC on May 13, 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/20240613476477/en/
INVESTOR CONTACT: Vincent Perrone Senior Director,
Investor Relations vincent.perrone@UroGen.com 609-460-3588 ext.
1093
MEDIA CONTACT: Cindy Romano Director, Communications
cindy.romano@urogen.com 908-963-7827
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