ENVISION Trial Results Published in the Journal of Urology Report 82.3% Duration of Response 12 Months after Achieving Complete Response for UGN-102, Potentially First FDA-Approved Non-Surgical Treatment for LG-IR-NMIBC
28 Ottobre 2024 - 1:00PM
Business Wire
- The Kaplan-Meier Estimate of Duration of Response at 12 Months
in Patients Who Achieved a Complete Response at Three Months was
82.3%
- Patients Receiving UGN-102 had a 79.6% Complete Response Rate
at Three Months
- Side Effect Profile Consistent with Previous Clinical Trials of
UGN-102
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing innovative solutions that treat
urothelial and specialty cancers, today announced that new
long-term durability of response results from the Phase 3 ENVISION
study of investigational drug UGN-102 in patients with low-grade
intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC)
were published online in the Journal of Urology.
In ENVISION, UGN-102 treatment was associated with an
unprecedented 82.3% (95% CI, 75.9%, 87.1%) 12-month duration of
response (DOR) by Kaplan-Meier estimate (n=108) in patients who
achieved complete response (CR) at three months after the first
instillation of investigational drug UGN-102 (mitomycin) for
intravesical solution. The DOR Kaplan-Meier estimates at 15 months
(n=43) and 18 months (n=9) after 3-month CR were both 80.9% (95%
CI, 73.9%, 86.2%). 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.
“These data demonstrate that treatment with UGN-102 results in a
clinically meaningful CR rate and that the durability of the
response in patients with LG-IR-NMIBC is robust,” said Sandip
Prasad, MD, M.Phil., Director of Genitourinary Surgical Oncology,
Morristown Medical Center/Atlantic Health System, NJ and Principal
Investigator of the ENVISION trial. “This study adds to the
mounting evidence supporting UGN-102 as a potentially valuable
treatment option for patients with recurrent LG-IR-NMIBC.”
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 in January 2024 and
completed the NDA submission in August, ahead of schedule. The FDA
accepted the NDA for UGN-102 with a PDUFA goal date of June 13,
2025.
Liz Barrett, President and CEO of UroGen, emphasized the
significance of the DOR findings from the ENVISION study, stating,
“LG-IR-NMIBC patients are typically elderly and currently treated
with repeated surgeries under general anesthesia that are
associated with physical and quality of life detriments. These new
results continue to strengthen UGN-102’s potential as a treatment
option for these patients that extends their recurrence-free
interval. The highly recurrent nature of LG-IR-NMIBC underscores
the urgent need for innovative options for patients facing this
challenging 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 and resolved or resolving. The
ENVISION trial demonstrated a similar safety profile to that
observed in other studies of UGN-102.
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 completed the NDA submission in August, ahead
of schedule. The FDA accepted the NDA for UGN-102 and assigned a
PDUFA goal date of June 13, 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 increased
risk of comorbidities, with the median age of diagnosis being 73
years. Guideline recommendations for the management of NMIBC
include trans-urethral resection of bladder tumor (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 a 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. 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 chemoablative,
non-surgical treatment for LG-IR-NMIBC; the estimated annual U.S.
patient population and demographics for LG-IR-NMIBC; the potential
benefits to patients and opportunities for UGN-102, if approved;
statements related to UroGen’s NDA submission for UGN-102 and the
potential approval and timing thereof; 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: even though the NDA for UGN-102 has been accepted for filing 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 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; and UroGen
may not successfully develop and receive regulatory approval of any
other product that incorporates 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 June 30, 2024, filed with the
SEC on August 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20241028821933/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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