New data from Phase 2b
SunRISe-1 study show rapid achievement of complete response (CR)
with 98% achieving a CR within 12 weeks
TAR-200 provides durable CRs in patients with Bacillus
Calmette-Guérin (BCG)–unresponsive high-risk
non–muscle-invasive bladder cancer (NMIBC) with carcinoma in
situ – a disease area with limited treatment options for
patients
SAN
ANTONIO, May 3, 2024 /PRNewswire/ -- Johnson &
Johnson announced today updated results from Cohort 2 of the Phase
2b SunRISe-1 study evaluating the
efficacy and safety of investigational TAR-200 monotherapy in
patients with BCG-unresponsive high-risk non–muscle-invasive
bladder cancer (HR-NMIBC) with carcinoma in situ, who are
ineligible for, or decline, radical cystectomy. These data were
featured today in a plenary session (Abstract
#P2-01) at the 2024 American Urological Association Annual
Meeting (AUA) taking place May 3-6,
2024, in San Antonio,
Texas.
"The high complete response rate and durability of these
responses observed in patients treated with TAR-200 underscores the
potential of this treatment approach for patients with
BCG-unresponsive HR-NMIBC," said Joseph
Jacob,* M.D., M.S., Department of Urology, Upstate Medical
University, presenting author. "These results address an area of
high unmet need for bladder sparing therapies in this patient
population."
Results included an evaluation of 85 patients (median age of 71
years old: range 40-88; 32.9% with concurrent papillary disease)
who received TAR-200 monotherapy. The centrally confirmed complete
response (CR) rate was 82.8% by urine cytology and/or biopsy (95%
confidence interval [CI], 70.6-91.4). The study protocol did not
allow retreatment for nonresponders, consistent with U.S. Food and
Drug Administration (FDA) guidance. The estimated 1-year duration
of response (DOR) rate is 74.6% (95% CI, 49.8-88.4), with median
follow-up in responders of 29.9 weeks (range, 14-140); 41 of 48
responders (85%) remain in CR at data cutoff as of January 2, 2024, and none of the responders
progressed to muscle-invasive bladder cancer or metastasis.
Ninety-eight percent (47 of 48) of CRs were achieved at first
disease assessment at week 12, and four of five patients who have
completed two years of treatment remain in CR. The
investigator-assessed confirmed CR rate correlated strongly with
central results.1
Interim results from the SunRISe-1 study were featured at the
European Society for Medical Oncology 2023 Congress and shared at
AUA 2023. These results were also presented at the European
Association of Urology 2024 Congress.
Treatment-related adverse events (TRAEs) occurred
in 61 patients (71.8%). The most common (≥10%) were pollakiuria
(35.3%), dysuria (29.4%), micturition urgency (15.3%), and urinary
tract infections (15.3%). Seven patients (8.2%) had Grade 3 or
higher TRAEs and four patients (4.7%) had one or more serious
TRAEs. Four patients (4.7%) had TRAEs leading to discontinuation
and no deaths were reported.
"These study results mark a significant step in our mission to
bring new treatment options to patients that focus on bladder
preservation and long-term survival," said Christopher Cutie, M.D., Vice President, Disease
Area Leader, Bladder Cancer, Johnson & Johnson Innovative
Medicine. "These results reinforce the potential of TAR-200 to
transform the treatment landscape and our ongoing dedication to
address unmet needs for patients facing this challenging
disease."
TAR-200 is an investigational targeted releasing system designed
to provide extended local release of gemcitabine into the bladder.
It is installed in a physician's office setting during a 3- to
5-minute procedure with no anesthesia. In December 2023, the FDA granted TAR-200
Breakthrough Therapy Designation (BTD) for the potential future
treatment of patients with BCG-unresponsive HR-NMIBC, who are
ineligible for or elected not to undergo radical cystectomy
(surgical removal of the bladder).
Bladder cancer is the sixth most common cancer in the U.S., with
more than 83,000 patients diagnosed each year, with NMIBC
accounting for about 75-85% of all newly diagnosed bladder
cancers.2,3 Although BCG immunotherapy has been
accepted as the standard of care for nearly five decades, 30-40% of
patients do not respond to BCG and experience disease recurrence or
progression.4 In such scenarios, radical cystectomy
(removal of the bladder and neighboring structures and organs)
emerges as the primary treatment option. This major abdominal
procedure requires a urinary diversion to be created to collect and
store urine.5
About SunRISe-1
SunRISe-1 (NCT04640623) is a
randomized, parallel-assignment, open-label Phase 2 clinical study
evaluating the safety and efficacy of TAR-200 in combination with
cetrelimab, TAR-200 alone, or cetrelimab alone for BCG-unresponsive
HR-NMIBC carcinoma in situ (CIS) patients who are ineligible for,
or elected not to undergo, radical cystectomy. Participants are
randomized to 1 of 4 cohorts: treatment with TAR-200 in combination
with cetrelimab (Cohort 1), TAR-200 alone (Cohort 2), cetrelimab
alone (Cohort 3), or TAR-200 alone with papillary disease only
(Cohort 4). The primary endpoint is CR rate at any time point.
Secondary endpoints include DOR, overall survival,
pharmacokinetics, quality of life, safety and tolerability. Cohorts
1 and 3 were closed to further enrollment effective June 1, 2023.
About TAR-200
TAR-200 is an investigational targeted
releasing system, enabling controlled release of gemcitabine into
the bladder, increasing the amount of time the drug delivery system
spends in the bladder and sustaining local drug exposure. The
safety and efficacy of TAR-200 are being evaluated in Phase 2 and
Phase 3 studies in patients with muscle-invasive bladder cancer in
SunRISe-2 and SunRISe-4, NMIBC in SunRISe-1,
SunRISe-3 and SunRISe-5.
About Cetrelimab
Administered intravenously,
cetrelimab is an investigational programmed cell death receptor-1
(PD-1) monoclonal antibody being studied for the treatment of
bladder cancer, prostate cancer, melanoma, and multiple myeloma as
part of a combination treatment. Cetrelimab is also being evaluated
in multiple other combination regimens across the Janssen Oncology
portfolio.
About High-Risk Non–Muscle-Invasive Bladder
Cancer
High-risk non–muscle-invasive bladder cancer
(HR-NMIBC) is a type of non-invasive bladder cancer that is more
likely to recur or spread beyond the lining of the bladder, called
the urothelium, and progress to invasive bladder cancer compared to
low-risk NMIBC.6,7 HR-NMIBC makes up 15-44% of
patients with NMIBC and is characterized by a high-grade, large
tumor size, presence of multiple tumors, and CIS. Radical
cystectomy is currently recommended for NMIBC patients who fail BCG
therapy, with over 90% cancer-specific survival if performed before
muscle-invasive progression.8,9 Given that NMIBC
typically affects older patients, many may be unwilling or unfit to
undergo radical cystectomy.10 The high rates of
recurrence and progression can pose significant morbidity and
distress for these patients.6,10
About Johnson & Johnson
At Johnson &
Johnson, we believe health is everything. Our strength in
healthcare innovation empowers us to build a world where complex
diseases are prevented, treated, and cured, where treatments are
smarter and less invasive, and solutions are personal. Through our
expertise in Innovative Medicine and MedTech, we are uniquely
positioned to innovate across the full spectrum of healthcare
solutions today to deliver the breakthroughs of tomorrow, and
profoundly impact health for humanity. Learn more at
https://www.jnj.com/ or at
www.janssen.com/johnson-johnson-innovative-medicine. Follow us
at @JanssenUS and @JNJInnovMed. Janssen Research
& Development, LLC and Janssen Biotech, Inc., are both Johnson
& Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development and the potential benefits and
treatment impact of TAR-200 or cetrelimab. The reader is cautioned
not to rely on these forward-looking statements. These statements
are based on current expectations of future events. If underlying
assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially
from the expectations and projections of Janssen Research &
Development, LLC, Janssen Biotech, Inc., and/or Johnson
& Johnson. Risks and uncertainties include, but are not limited
to: challenges and uncertainties inherent in product research and
development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
competition, including technological advances, new products and
patents attained by competitors; challenges to patents; changes in
behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
December 31, 2023, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in Johnson &
Johnson's subsequent Quarterly Reports on Form 10-Q and other
filings with the Securities and Exchange Commission. Copies of
these filings are available online at
www.sec.gov, www.jnj.com or on request from
Johnson & Johnson. None of Janssen Research & Development,
LLC, Janssen Biotech, Inc., nor Johnson & Johnson undertakes to
update any forward-looking statement as a result of new information
or future events or developments.
*Dr. Jacob has not been paid for any media work.
1 Necchi A, Daneshmand S, Simone G,
Xylinas E, Morris DS, Zainfeld D, et al. P2-01 TAR-200 in patients
with Bacillus Calmette-Guérin-unresponsive high-risk
non–muscle-invasive bladder cancer: results from SunRISe-1
study. Journal of Urology. 2024;211.
2 Key statistics for bladder cancer. American Cancer
Society. Accessed April 1, 2024.
https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html#:~:text=time%20of%20diagnosis-,How%20common%20is%20bladder%20cancer?,men%20and%204%2C550%20in%20women)
3 Deng S, Meng F, Wang L, et al. Global research trends
in non–muscle invasive bladder cancer: bibliometric and visualized
analysis. Front Oncol. 2022;12:1044830. Published 2022 Nov
17. doi:10.3389/fonc.2022.1044830
4 Zlotta AR, Fleshner NE, Jewett MA. The management
of BCG failure in non-muscle-invasive bladder cancer: an update.
Can Urol Assoc J. 2013;3(6-S4):199.
5 Bladder removal surgery: What is a radical cystectomy?
Bladder Cancer Advocacy Network. Accessed April 1, 2024.
https://bcan.org/bladder-removal-surgery/.
6 Grab-Heyne K, Henne C, Mariappan P, et al.
Intermediate and high-risk non–muscle-invasive bladder cancer: an
overview of epidemiology, burden, and unmet needs. Front
Oncol. 2023;13:1170124.
7 Lieblich A, Henne C, Mariappan P, Geiges G, Pöhlmann
J, Pollock RF. The management of non–muscle-invasive bladder
cancer: A comparison of European and UK guidelines. J Clin
Urol. 2018;11(2):144-148.
8 Brooks NA, O'Donnell MA. Treatment options in
non–muscle-invasive bladder cancer after BCG failure. Indian J
Urol. 2015;31(4):312-319. doi:10.4103/0970-1591.166475
9 Guancial EA, Roussel B, Bergsma DP, et al. Bladder
cancer in the elderly patient: challenges and solutions. Clin
Interv Aging. 2015;10:939-949.
10 Chamie K, Litwin MS, Bassett JC, et al. Recurrence of
high-risk bladder cancer: A population-based analysis.
Cancer. 2013;119(17):3219-3227.
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