The Journal of Urology Publishes Peer-Reviewed Article Highlighting UGN-102 Data in Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
08 Agosto 2023 - 7:00AM
Business Wire
-- Phase 3 ATLAS Clinical Trial Shows UGN-102 Demonstrated
Superiority to TURBT with a 55% Reduction of Risk for Recurrence,
Progression or Death in Patients who Received UGN-102 --
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing novel solutions that treat
urothelial and specialty cancers, today announced that The Journal
of Urology published data from the Phase 3 ATLAS trial for
investigational agent UGN-102 (mitomycin) for intravesical solution
in patients with low-grade, intermediate-risk non-muscle invasive
bladder cancer (LG-IR-NMIBC), that demonstrated superiority to
transurethral resection of bladder tumor surgery (TURBT) with a 55%
reduction of risk for recurrence, progression, or death in patients
who received UGN-102. Tumor-free complete response rate at three
months was 65% for patients who only received UGN-102, compared to
a 64% complete response rate at three months for patients who
underwent TURBT. TURBT is the current standard of care for patients
with this type of cancer.
“The publication of our ATLAS data in The Journal of Urology
adds another chapter to our understanding of the potential of
UGN-102 as a treatment for patients with LG-IR-NMIBC, who often
face multiple surgeries due to the recurring nature of this
cancer,” said Mark Schoenberg, M.D., Chief Medical Officer at
UroGen. “Our hope is that one day urologists may have an effective,
non-surgical therapy option beyond TURBT that can be used to
address this large patient population.”
The Phase 3 ATLAS clinical trial, which met its primary
endpoint, evaluated the efficacy, durability, and safety of UGN-102
with or without TURBT vs. TURBT alone in 282 patients with
LG-IR-NMIBC. UroGen recently announced positive topline data from
ATLAS and the Phase 3 ENVISION trial. The ENVISION trial evaluated
the efficacy and safety of UGN-102 as a primary chemoablative
therapy in 240 patients with LG-IR-NMIBC and met its primary
endpoint by demonstrating that patients treated with UGN-102 had a
79.2% rate of complete response at 3-months following the initial
treatment.
The Journal of Urology publication includes the following
findings from ATLAS:
- Tumor-free complete response 3 months after initial treatment
was achieved by 92 patients (65%) who received UGN-102 and 89
patients (64%) treated by TURBT.
- UGN-102 was generally well tolerated, with a side effect
profile similar to that of previous clinical trials.
The estimated probability of remaining event free 15 months
after randomization was 72% for UGN-102 ± TURBT and 50% for TURBT
monotherapy [hazard ratio 0.45].
“While TURBT is the standard treatment for bladder cancer, the
recurrent nature of LG-IR-NMIBC means that patients will undergo
multiple surgeries that come with risks for this older patient
population,” says Sandip Prasad, M.D., M.Phil., Director of
Genitourinary Surgical Oncology, Morristown Medical Center/Atlantic
Health System, NJ, and Chief Investigator in the ATLAS trial. “It
is exciting to consider what a potential non-surgical therapeutic
alternative could mean for both patients and doctors who are eager
for additional options.”
Additional data evaluating the secondary endpoint of the
ENVISION trial, Duration of Response, is expected in 2024. Assuming
positive findings, a New Drug Application (NDA) is anticipated to
be submitted to the U.S. Food and Drug Administration (FDA) in the
same year.
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an
investigational drug formulation of mitomycin 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.
Assuming positive findings from the durability of response endpoint
from the ENVISION Phase 3 study, UroGen anticipates submitting a
New Drug Application (NDA) for UGN-102 in 2024. If approved,
UGN-102 would be the first non-surgical primary therapeutic to
treat a subset of bladder cancer characterized by high recurrence
rates and multiple surgeries.
About ATLAS
ATLAS is a global, open-label, randomized controlled Phase 3
trial designed to assess the efficacy and safety of UGN-102, with
or without TURBT, vs. TURBT alone in patients diagnosed with
LG-IR-NMIBC. The trial enrolled 282 patients in clinical sites in
the U.S., Europe and Israel. Patients were randomized 1:1 to either
UGN-102 or TURBT. Patients in the UGN-102 arm were treated with six
weekly intravesical instillations of UGN-102. At the 3-month time
point, patients were assessed for response. Patients who
demonstrated a complete response to either UGN-102 or TURBT, were
assessed for long-term follow-up for evidence of recurrence.
Patients who demonstrated presence of persistent disease at
3-months, in either arm, underwent a TURBT and continued for
long-term follow-up for evidence of recurrence. The primary
endpoint of the study is disease-free survival. Learn more about
the ATLAS trial at www.clinicaltrials.gov (NCT04688931).
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 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. JELMYTO®
(mitomycin) for pyelocalyceal solution 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 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 to be the first non-surgical primary
therapeutic to treat a subset of bladder cancer characterized by
high recurrence rates and multiple surgeries; the expected timing
for additional data evaluating the secondary endpoint of duration
of response from ENVISION; the anticipated submission of an NDA for
UGN-102 in 2024; and 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: preliminary results
may not be indicative of results that may be observed in the
future; the timing and success of clinical trials and potential
safety and other complications thereof; unforeseen delays that may
impact the timing of progressing clinical trials and reporting
data; 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 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, 2023 filed with the SEC in May
11, 2023 (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.
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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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