RARITAN, NJ, October 20, 2025 – Johnson & Johnson (NYSE:JNJ) announced today that new data from the primary analysis of the ongoing Phase 2b SunRISe-4 study demonstrated that treatment with INLEXZO™ (gemcitabine intravesical system) plus intravenous (IV) cetrelimab (CET) before radical cystectomy resulted in a clinically meaningful rate of pathologic complete response (pCR) and pathologic overall response (pOR) in patients with muscle invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant platinum-based chemotherapy and are scheduled for bladder removal.[i] These data were featured as a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) 2025 Congress (Abstract #LBA112).
“The SunRISe-4 data show that the ability of INLEXZO to provide extended local delivery of a cancer medication in the bladder, together with the systemic PD-1 inhibitor cetrelimab, may lead to a significant rate of complete pathological responses while remaining manageable and safe for patients,” said Andrea Necchi, M.D., of Italy’s Vita-Salute San Raffaele University and the IRCCS San Raffaele Hospital and Scientific Institute, presenting author of the study. “These early results support the potential role of neoadjuvant combination therapy in future muscle invasive trials.”
In the Phase 2b SunRISe-4 study, patients in cohort 1 (n=101) received four cycles of INLEXZO™ (225 mg of gemcitabine) inserted by catheter into the bladder plus 360 mg of IV CET every 21 days while patients in cohort 2 (n=58) were treated with four cycles of 360 mg of IV CET monotherapy every 21 days. In the primary analysis of the SunRISe-4 study, neoadjuvant treatment with INLEXZO™ plus CET or CET alone showed overall efficacy with a centrally confirmed pathologic complete response (pCR) rate of 38% and 28%, respectively (95% confidence interval [CI], 28-49, 16-44), in patients with histologically proven, non-metastatic MIBC. The pathological overall response (pOR) rate (defined as the proportion of patients ≤ pT1 or downstaging to non-muscle invasive disease) was 53% and 44%, respectively (95% CI, 43-64; 29-59). The one-year recurrence-free survival (RFS) was 77% and 64%, respectively (95% CI, 67-85; 47-77).1
No new safety signals were observed with INLEXZO™, CET, or the combination. In Cohort 1 (INLEXZO™ + CET), 81.2% experienced treatment-related adverse events (TRAEs), with 15.8% at Grade ≥3. In Cohort 2 (CET monotherapy), 51.7% experienced TRAEs, with 10.3% at Grade ≥3. The most common events included dysuria, pollakiuria, and fatigue. Serious TRAEs occurred in 13.9% of patients in Cohort 1 and 5.2% in Cohort 2. Importantly, no treatment-related deaths occurred with the combination, and immune-related TRAEs were generally manageable across both groups.1
Additionally, exploratory urine tumor DNA and circulatory tumor DNA results support further investigation as predictive biomarkers of residual disease after neoadjuvant therapy in this patient population.1
“The current treatment landscape offers few alternatives to cisplatin-based chemotherapy prior to radical cystectomy for patients with muscle-invasive bladder cancer,” said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson Innovative Medicine. “With no signs of detectable cancer in more than a third of patients prior to surgery, we are looking forward to following up on recurrence-free survival endpoints in these patients post-cystectomy.”
Bladder cancer is the ninth most common cancer in the world.2 Muscle invasive bladder cancer (MIBC) is an aggressive form of the disease, where tumors have invaded the bladder muscle with or without lymph node involvement, and accounts for an estimated 20% of newly diagnosed bladder cancer cases globally.3,4 This life-threatening stage of the disease typically requires a radical cystectomy (removal of the bladder and neighboring structures and organs), requiring a urinary diversion to be created to collect and store urine.5 Standard treatment before surgery is cisplatin-based chemotherapy, which can improve long-term outcomes, but nearly 50% of patients are unable to receive it due to factors such as poor kidney function, other health conditions, or personal choice.6,7
About SunRISe-4
SunRISe-4 (
NCT04919512) is an open-label, multicenter, randomized Phase 2b study assessing the efficacy and safety of neoadjuvant TAR-200 + cetrelimab (CET) (anti-programmed death-1 antibody) or neoadjuvant CET alone in patients with MIBC scheduled for RC who are ineligible for or refuse neoadjuvant cisplatin-based chemotherapy. SunRISE-4 is not a registrational trial for INLEXZO™ or CET.
About INLEXZO™
INLEXZO™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO™ is an intravesical system enabling extended release of gemcitabine into the bladder.
The safety and efficacy of INLEXZO™ are being evaluated in clinical trials in patients with MIBC in SunRISe-4 (non-registration), and NMIBC in SunRISe-1, SunRISe-3, and SunRISe-5.
The legal manufacturer for INLEXZO™ is Janssen Biotech, Inc.
For more information, visit: https://www.INLEXZO.com.
INLEXZO™ INDICATION AND IMPORTANT SAFETY INFORMATION8
INDICATION INLEXZO™ (gemcitabine intravesical system) is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
CONTRAINDICATIONS
INLEXZO™ is contraindicated in patients with:
- Perforation of the bladder.
- Prior hypersensitivity reactions to gemcitabine or any component of the product.
WARNINGS AND PRECAUTIONS
Risks in Patients with Perforated Bladder
INLEXZO™ may lead to systemic exposure to gemcitabine and to severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised.
Evaluate the bladder before the intravesical administration of INLEXZO™ and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored.
Risk of Metastatic Bladder Cancer with Delayed Cystectomy
Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.
Of the 83 evaluable patients with BCG-unresponsive CIS treated with INLEXZO™ in Cohort 2 of SunRISe-1, 7 patients (8%) progressed to muscle invasive (T2 or greater) bladder cancer. Three patients (3.5%) had progression determined at the time of cystectomy. The median time between determination of persistent or recurrent CIS or T1 and progression to muscle invasive disease was 94 days.
Magnetic Resonance Imaging (MRI) Safety
INLEXZO™ can only be safely scanned with MRI under certain conditions. Refer to section 5.3 of the USPI for details on conditions.
Embryo-Fetal Toxicity
Based on animal data and its mechanism of action, INLEXZO™ can cause fetal harm when administered to a pregnant woman if systemic exposure occurs. In animal reproduction studies, systemic administration of gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits.
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after final removal of INLEXZO™. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after final removal of INLEXZO™.
ADVERSE REACTIONS
Serious adverse reactions occurred in 24% of patients receiving INLEXZO™. Serious adverse reactions that occurred in >2% of patients included urinary tract infection, hematuria, pneumonia, and urinary tract pain. Fatal adverse reactions occurred in 1.2% of patients who received INLEXZO™, including cognitive disorder.
The most common (>15%) adverse reactions, including laboratory abnormalities, were urinary frequency, urinary tract infection, dysuria, micturition urgency, decreased hemoglobin, increased lipase, urinary tract pain, decreased lymphocytes, hematuria, increased creatinine, increased potassium, increased AST, decreased sodium, bladder irritation, and increased ALT.
USE IN SPECIFIC POPULATIONS
Pregnancy
There are no available data on the use of INLEXZO™ in pregnant women to inform a drug-associated risk.
Please see Embryo-Fetal Toxicity for risk information related to pregnancy.
Lactation
Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 1 week after final removal of INLEXZO™.
Females and Males of Reproductive Potential
Pregnancy Testing - Verify pregnancy status in females of reproductive potential prior to initiating INLEXZO™.
Contraception - Please see Embryo-Fetal Toxicity for information regarding contraception.
Infertility (Males) - Based on animal studies, INLEXZO™ may impair fertility in males of reproductive potential. It is not known whether these effects on fertility are reversible.
Geriatric Use
Of the patients given INLEXZO™ monotherapy in Cohort 2 of SunRISe-1, 72% were 65 years of age or older and 34% were 75 years or older. There were insufficient numbers of patients <65 years of age to determine if these patients respond differently to patients 65 years of age and older.
Please read full Prescribing Information and Instructions for Use for INLEXZO™.
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.innovativemedicine.jnj.com. Follow us at
@JNJInnovMed.
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 INLEXZO™ and 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 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; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; 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 most recent Annual Report on Form 10-K, 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 http://www.sec.gov, http://www.jnj.com, or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Footnotes
*Dr. Andrea Necchi has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.
1 Necchi, A. et al., Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab or cetrelimab alone in patients with muscle-invasive bladder cancer: SunRISe-4 primary analysis and biomarker results. European Society for Medical Oncology (ESMO) Congress 2025. October 17, 2025.
2 Globocan 2022 https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf
3 Witjes J. A. et al. European Association of Urology guidelines on muscle-invasive and metastatic bladder cancer. Eur Urol. 2021;79(1):82-104.
4 Chu, C., Porten, S. (2021). Epidemiology of Bladder Cancer: Trends and Disparities. In: Bjurlin, M.A., Matulewicz, R.S. (eds) Comprehensive Diagnostic Approach to Bladder Cancer. Springer, Cham. https://doi.org/10.1007/978-3-030-82048-0_1
5 Bladder removal surgery: What is a radical cystectomy? Bladder Cancer Advocacy Network. Accessed April 1, 2024. https://bcan.org/bladder-removal-surgery/.
6 Jiang, D.M., Gupta, S., Kitchlu, A. et al. Defining cisplatin eligibility in patients with muscle-invasive bladder cancer. Nat Rev Urol 18, 104–114 (2021). https://doi.org/10.1038/s41585-020-00404-6
7 Giles M, Crabb SJ. Systemic Treatment-Decision Algorithms in Muscle-Invasive Bladder Cancer: Clinical Complexities and Navigating for Improved Outcomes. Res Rep Urol. 2023;15:321-331 https://doi.org/10.2147/RRU.S386549
8 INLEXZO™ U.S. Prescribing Information.
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