ENVISION Trial Results Published in the February Issue of The Journal of Urology Highlight UGN-102 Achievement of 82.3% Duration of Response at 12 Months Paving the Way for the Potential First FDA-Approved Treatment for LG-IR-NMIBC in June 2025
January 15 2025 - 8:00AM
Business Wire
- ENVISION Reports 79.6% Complete Response Rate at 3 Months,
82.3% Duration of Response at 12 Months, and Consistent Safety
Profile
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing innovative solutions that treat
urothelial and specialty cancers, today announced that the 3-month
complete response (CR) rate and 12-month durability of response
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 in the February issue
of The Journal of Urology.
In the ENVISION trial, UGN-102 treatment demonstrated an
impressive 82.3% (95% CI, 75.9%, 87.1%) 12-month duration of
response (DOR) by Kaplan-Meier estimate (n=108) in patients who
achieved a CR at three months after the first instillation of
UGN-102 (mitomycin) for intravesical solution. The Kaplan-Meier
estimates for DOR at 15 months (n=43) and 18 months (n=9) following
the 3-month CR were both 80.9% (95% CI, 73.9%, 86.2%). The ENVISION
trial also met its primary endpoint, showing a 79.6% (95% CI,
73.9%, 84.5%) CR rate at three months in patients treated with
UGN-102.
“These data from the ENVISION trial provide compelling evidence
that treatment with UGN-102 achieves a clinically meaningful
complete response rate and also demonstrates remarkable durability
in patients with LG-IR-NMIBC,” said Sandip Prasad, MD, M.Phil.,
Director of Genitourinary Surgical Oncology at Morristown Medical
Center/Atlantic Health System, NJ, and Principal Investigator of
the ENVISION trial. “The long-term results, with 82.3% duration of
response at 12 months, further strengthen UGN-102’s potential as a
non-surgical, effective treatment for patients facing the recurrent
and challenging nature of LG-IR-NMIBC.”
According to Mark Schoenberg, M.D., Chief Medical Officer,
UroGen, "The impressive duration of response data from the ENVISION
trial further highlights UGN-102’s potential to transform the
treatment landscape for patients with LG-IR-NMIBC. Many of these
patients are elderly and face the burden of repeated surgeries
under general anesthesia, so there is a critical need for
innovative treatment options for this patient population. We
believe that, if approved, UGN-102’s ability to achieve durable
complete responses and potentially reduce recurrence rates while
extending treatment-free intervals will represent a significant
advance in managing 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.
The most common treatment-emergent adverse events (TEAEs) in the
ENVISION trial were dysuria, hematuria, urinary tract infection,
pollakiuria, fatigue, and urinary retention. The TEAEs were
typically mild-to-moderate in severity and either resolved or were
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 23,000 newly
diagnosed bladder cancer patients each year and an estimated 59,000
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 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, including
to transform the treatment landscape for patients with LG-IR-NMIBC;
statements related to UroGen’s NDA submission and expected PDUFA
target action date 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 September 30, 2024, filed with
the SEC on November 6, 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/20250115929797/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 609-460-3583 ext. 1083
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