- New and Recurrent Patients Treated with UGN-102 Achieved
Similar Durability of Response Rates (DOR) at 12 months
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing innovative solutions that treat
urothelial and specialty cancers, today announced results from a
new analysis of the ATLAS trial, which estimates using Kaplan Meier
methods the probabilities of remaining in complete response for
both new and recurrent low-grade intermediate-risk non- muscle
invasive bladder cancer (LG-IR-NMIBC) patients following treatment
with investigational drug UGN-102 as primary therapy, with or
without subsequent transurethral resection of the bladder tumor
(TURBT) at 3 months.
"These compelling findings shed light on the potential of
UGN-102 as a nonsurgical primary treatment for low-grade
intermediate-risk bladder cancer," said William Huang, M.D.,
Urologic Oncologist, Professor and Vice Chair of Urology, NYU
Grossman School of Medicine. "These data are an encouraging step
forward in addressing the broad spectrum of LG-IR-NMIBC and
potentially curbing the high rates of disease recurrence associated
with it."
In the Phase 3 ATLAS study, 282 patients with new or recurrent
LG-IR-NMIBC were randomized to primary treatment with UGN-102 ±
TURBT or TURBT alone. In the overall study population, Disease Free
Survival (DFS) and DOR favored primary treatment with UGN-102 ±
TURBT compared to TURBT alone. Complete response (CR) rates at the
3-month disease assessment were similar in both arms. While DFS and
DOR rates were previously shared for both arms of the study, these
are the first data specifically looking at the rates among new and
recurrent patients within the UGN-102 ± TURBT arm. In this analysis
using Kaplan Meier methods, DOR at 12 months after achieving CR at
3 months was 87.5% and 69.1% in new and recurrent patients,
respectively. Also, patients achieved similar probabilities of DFS
rates for UGN-102 at 15 months from randomization (77.4% and 63.2%
in new and recurrent patients, respectively).
"These insightful data underscore the potential of UGN-102
impacting the treatment landscape for LG-IR-NMIBC," said Mark
Schoenberg, M.D., Chief Medical Officer, UroGen. "Our aim is for
UGN-102 to emerge as a non-surgical option for LG-IR-NMIBC,
potentially sparing patients from the complexities and burdens
associated with repetitive surgeries, including their inherent
risks, side effects, and substantial impact on both individuals and
healthcare systems."
Topline data from both the ATLAS trial and the Phase 3 ENVISION
trial were initially shared in July of 2023. Twelve-month DOR data
from the pivotal Phase 3 ENVISION trial are expected in June
2024.
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. Assuming positive findings from
the durability of response endpoint from the ENVISION Phase 3
study, UroGen anticipates completing its New Drug Application (NDA)
submission for UGN-102 in September 2024 with a potential U.S. Food
and Drug Administration (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 (SOC). 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 ATLAS
ATLAS was 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 duration of response. 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 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 3-month assessment after the first instillation, and
the key secondary endpoint will evaluate durability over time in
patients who achieved a CR at the 3-month assessment. Based on
discussions with the FDA, and assuming positive findings, UroGen
anticipates submitting an NDA for UGN-102 in September 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 of UGN-102 as a nonsurgical primary treatment for
low-grade intermediate-risk bladder cancer and to potentially curb
the high rates of disease recurrence associated with, and impact
the treatment landscape for, LG-IR-NMIBC, including potentially
sparing patients from the complexities and burdens associated with
repetitive surgeries and their inherent risks, side effects and
impact on individuals and healthcare systems; the Phase 3 ENVISION
trial, including the expected release of data in June 2024;
UroGen’s plans to complete its NDA submission for UGN-102 in
September 2024 if DOR endpoint data from the Phase 3 ENVISION trial
is positive, with a potential FDA decision as early as the first
quarter of 2025; the estimated patient population for LG-IR-NMIBC;
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 ATLAS and this
pre-specified analysis may not be indicative of results that may be
observed in the future; findings from the DOR endpoint from the
Phase 3 ENVISION trial may not be positive, and in such event,
UroGen’s NDA pathway could be negatively impacted; even if DOR
endpoint data from the Phase 3 ENVISION trial are positive, there
is no guarantee that the current clinical development plan for
UGN-102 will ultimately support the submission of an NDA; 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; potential safety and other
complications from UGN-102; 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;
the ability to obtain and maintain adequate intellectual property
rights and adequately protect and enforce such rights;
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 the
growth of the market(s) for UroGen’s product and product
candidates, the rate and degree of market acceptance thereof
vis-à-vis alternative therapies; UroGen’s ability to attract or
retain key management, members of its 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 UroGen’s RTGel technology;
and 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240504411697/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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