Inlexzo (gemcitabine intravesical system) / J&J - LARVOL DELTA

SunRISe-1: A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (clinicaltrials.gov) - P2 | N=220 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jul 2027 ➔ Sep 2027 | Trial primary completion date: Sep 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Johnson & Johnson (NYSE:JNJ) announced today that new data from the investigational Cohort 4 of the Phase 2b SunRISe-1 study… (PRNewswire) - "These data were featured as a late-breaking oral presentation at the Society of Urologic Oncology (SUO) 2025 Annual Meeting....Cohort 4 of the Phase 2b SunRISe-1 study focused on 52 patients with papillary-only, high-risk NMIBC....At median follow-up of 15.9 months (range, 4-20 months), the one-year DFS rate was 74.3 percent (95 percent confidence interval [CI], 59.2-84.6), meaning nearly three out of four patients remained free from cancer recurrence. Results were similar across patients with high-grade Ta and T1 papillary tumors, 74.8 percent and 74.1 percent, respectively (95 percent CI, 54.3-87.1 and 48.5-88.3). At one year, PFS was 95.6 percent (95 percent CI, 83.5-98.9) and OS was 98 percent (95 percent CI, 86.6-99.7)."

Late-breaking abstract • P2b data • Bladder Cancer

Gemcitabine intravesical system plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with MIBC: primary analysis and biomarker results of SunRISe-4. (PubMed, J Clin Oncol) - P2 | "TAR-200 plus cetrelimab provided higher pCR, pOR, and 1-year RFS rates compared with cetrelimab monotherapy, supporting further investigation of the neoadjuvant combination in MIBC. utDNA and ctDNA MRD results support further investigation as biomarkers for residual local and non-local disease, respectively."

Biomarker • Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Cost per Responder of TAR-200 vs. Other FDA-Approved Novel and Generic Treatments Among Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer With Carcinoma in Situ in the United States (ISPOR-EU 2025) - "Patients treated with TAR-200 monotherapy were compared to those treated with pembrolizumab, nadofaragene firadenovec (NF), nogapendekin alfa inbakicept (NAI)+BCG (with and without reinduction), or valrubicin based on published clinical trial data. TAR-200 demonstrated the highest proportion of patients achieving and sustaining CR for ≥12 months, translating to substantial cost savings per responder compared to other FDA-approved treatments for BCG-UR HR-NMIBC with CIS."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

GEMCITABINE INTRAVESICAL SYSTEM (TAR-200) MONOTHERAPY IN BACILLUS CALMETTE-GUÉRIN–UNRESPONSIVE HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER: CHARACTERIZATION OF RECURRENCE, PROGRESSION, AND TIME TO CYSTECTOMY (SUO 2025) - P2 | "SunRISe-1 Cohort 2 results show that TAR-200 monotherapy is associated with a high CR rate and durable responses, with minimal risk of disease progression to a more advanced (T2 or higher) disease stage, and a potential delay to RC. This low rate of progression compares favorably with historical progression rates of ~20% with standard of care in patients with HR NMIBC CIS. These results support TAR-200 as a novel bladder-sparing treatment option for patients with BCG-unresponsive CIS with or without papillary disease."

Monotherapy • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

BASELINE URINARY TUMOR DNA, MINIMAL RESIDUAL DISEASE AND GENOMIC DISEASE BURDEN IN RELATION TO CLINICAL RESPONSE TO TAR-200 IN THE PHASE 2B SUNRISE-1 TRIAL (SUO 2025) - "SunRISe-1 is an ongoing Phase 2b study assessing the safety and efficacy of TAR-200 ± cetrelimab (CET, an anti-PD-1 antibody) and CET alone in Bacillus Calmette-Guérin -unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease. While residual disease assessed by utDNA is a known prognostic factor, these results show TAR-200 treatment is associated with a high CR rate and durable responses in patients, independent of utDNA MRD status. This corroborates broad clinical activity observed with TAR-200 monotherapy in BCG-unresponsive high-risk-NMIBC with CIS with or without papillary disease."

Clinical • Minimal residual disease • P2b data • Residual disease • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

PHYSICIAN EXPERIENCES WITH TAR-200 IN HIGH-RISK NON-MUSCLE INVASIVE BLADDER CANCER: A QUALITATIVE STUDY OF SUNRISE TRIAL INVESTIGATORS (SUO 2025) - "This is the first study exploring physicians’ experiences of TAR-200 for HR-NMIBC. Findings indicate that the insertions and removals of TAR-200 are generally perceived as straightforward, efficient, and feasible across various clinical settings, as reported by trial PIs. Alongside clinical trial data, findings from this qualitative study support that TAR-200 could address unmet needs in HR-NMIBC by providing a patient- and provider-friendly treatment approach."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

Intravesical gemcitabine (Inlexzo) for bladder cancer. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Bladder Cancer, Version 2.2025. (NCCN)

NCCN guideline • Bladder Cancer

Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results (ESMO 2025) - P2 | "Conclusions At primary analysis, TAR-200 + CET showed high pCR, pOR and 1-y RFS, supporting a role for the combination in MIBC. Exploratory ut/ctDNA data support further investigation as predictive biomarkers for residual disease after neoadjuvant therapy in MIBC."

Biomarker • Clinical • Late-breaking abstract • Bladder Cancer • Genito-urinary Cancer • Oncology

TAR-200 monotherapy in patients with bacillus Calmette-Guérin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: first results from Cohort 4 of SunRISe-1 (JADPRO 2025) - "TAR-200 provides a consistent release of the chemotherapy drug cetuximab over the course of the 3-week dosing regimen. (6 month CR) and then Q12W for up to 2 years.• The study is ongoing, but not recruiting new patients for this cohort.• Data cutoff: July 15, 2024.Results• The 12-month DFS rate was 55.0% (95% CI: 43.9-65.9).• Median DFS was 22.5 months (95% CI: 18.8-NR).• Progression-free survival (PFS) rate at 12 months was 66.6% (95% CI: 55.0-76.6).• Overall survival (OS) rate at 12 months was 94.8% (95% CI: 85.6-98.3).• No new safety signals were observed, with most treatment-emergent adverse events (TEAEs) being Grade 1 or 2 and TEAEs leading to drug-related treatment-emergent adverse events (TRAEs) were low.• Most TRAEs were Grade 1 or 2.• The majority of TRAEs were TID related, with a median DOR of 2.7 weeks.• 5 patients (9.8%) had G3 TRAEs.• 1 patient (2.0%) had G4 TRAE (urinary tract infection).• 2 patients (3.9%) had SAE related to TRAEs.• 2 patients (3.9%)..."

Clinical • Monotherapy • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Solid Tumor

TAR-200 monotherapy in patients with bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1 (JADPRO 2025) - P2 | "TAR-200 monotherapy responses were durable, with a median duration of response of 20.8 months for 66.8% of the responders having no further intravesical high-dose therapy. Overall health status and high physical functioning were maintained while on TAR-200 treatment. TAR-200 monotherapy was well tolerated, with low rates of serious adverse events (SAEs) and treatment-related discontinuations (TRDs) leading to discontinuation."

Clinical • Monotherapy • Patient reported outcomes • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Solid Tumor

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. (J&J Press Release) - "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)."

P2b data • Bladder Cancer • Urothelial Cancer

Association of molecular markers with clinical response to TAR-200 in the phase IIb SunRISe-1 trial in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease (ESMO 2025) - P2 | "SunRISe-1 (NCT04640623) is an ongoing Phase 2b study assessing the safety and efficacy of TAR-200 ± cetrelimab (CET, antiPD-1) and CET alone in Bacillus Calmette-Guérin -unresponsive high-risk NMIBC with CIS, with/without papillary disease. CR rate (78.2% [95% CI 56.3%, 92,5%] vs 88.9% [95% CI 65.3%, 98.6%]) and median DOR (26.5 mo [8.31 mo, NE] vs NE [7.06 mo, NE]) were similar between MRD+ and MRD− pts. Conclusions TAR-200 monotherapy showed broad clinical activity in BCG unresponsive HR-NMIBC with CIS independent of baseline somatic alterations, PD-L1, and utDNA MRD status."

Biomarker • Clinical • IO biomarker • P2b data • Tumor mutational burden • Bladder Cancer • Genito-urinary Cancer • Microsatellite Instability • Oncology • Solid Tumor • HER-2 • MSI • PD-L1 • PIK3CA • TMB • TP53

Re: Siamak Daneshmand, Michiel S. Van der Heijden, Joseph M. Jacob, et al. TAR-200 for Bacillus Calmette-Guérin-unresponsive High-risk Non-muscle-invasive Bladder Cancer: Results from the Phase IIb SunRISe-1 Study. J Clin Oncol. In press. https://doi.org/10.1200/jco-25-01651. (PubMed, Eur Urol Focus) - No abstract available

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SunRISe-5: A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG) (clinicaltrials.gov) - P3 | N=272 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Natera to Present 14 Studies at ESMO, Including IMvigor011 Oral Presentation in Presidential Symposium (Businesswire) - "The IMvigor011 trial...has been selected for a Presidential Symposium on October 20....This oral presentation will include additional data on Signatera’s ability to predict disease-free survival (DFS) and overall survival (OS) benefit from adjuvant Tecentriq (atezolizumab) in muscle-invasive bladder cancer (MIBC)....MRD analysis from the Phase 3 CheckMate 274 trial will also be shared in an oral presentation on October 17. CheckMate 274 randomized high-risk MIBC patients 1:1 to Opdivo (nivolumab) or placebo for ≤ 1 year of adjuvant treatment....Additional oral presentations include results from the SunRISe-4 trial in MIBC, the INTERCEPT trial in colorectal cancer, and Natera’s early cancer detection program."

Clinical data • Bladder Cancer • Colorectal Cancer

Side effect management and procedural best practices with indwelling intravesical drug-releasing systems in the treatment of bladder cancer: recommendations from expert panels. (PubMed, Curr Opin Urol) - "Two separate expert panels were convened to develop recommendations for side effect management with iDRS and optimizing iDRS insertion procedure success. Stepwise treatment-specific management strategies for LUTS, UTIs, and hematuria in patients receiving iDRS treatment that are familiar to practicing urologists are presented, including considerations for continuation or discontinuation of iDRS treatment. Several advanced techniques can be considered to improve iDRS insertions based on variations in patient anatomy."

Adverse events • Journal • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Solid Tumor

Inlexzo (gemcitabine intravesical system): promising data but key questions remain. (PubMed, World J Urol) - "While Inlexzo is promising in a population where alternatives are scarce, its place must be clarified by longer-term follow-up, randomized comparisons versus systemic and intravesical therapies, and real-world experience. Prior to that, clinicians must utilize open counseling and shared decision-making."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Infectious Disease • Oncology • Solid Tumor

The Evolving Landscape of Systemic Immunotherapy for Bacillus Calmette-Guérin-naïve High-risk Non-muscle-invasive Bladder Cancer: At the Edge of a Tsunami? (PubMed, Eur Urol Oncol) - P3 | "The combination of systemic immunotherapy with intravesical BCG instillations is being investigated and may become a new therapeutic strategy for BCG-naïve HR NMIBC."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

TAR-200 monotherapy in patients with Bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year duration of response results from SunRISe-1 (DGU 2025) - P2 | "Conc.:TAR-200 monotherapy was well tolerated with the highest CR rate reported in BCG-unresponsive HR NMIBC. Responses were highly durable, and the majority of responders were disease-free at 1 y. Data will be updated once final results are available."

Clinical • Monotherapy • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

INNOVATIONS IN THERAPIES FOR BACILLUS CALMETTE-GUERIN (BCG) FAILURE NON-MUSCLE INVASIVE PATIENTS (PubMed, Harefuah) - "Diverse treatments, both systemic and local, administered directly into the bladder, have been investigated in recent years to mitigate the need for cystectomy. This review article provides an overview of current approved therapeutic options such as combined intravesical chemotherapy with gemcitabine and docetaxel, systemic therapy with pembrolizumab, intravesical therapy with nadofaragene firadenovec, and innovative investigational treatments including TAR-200 drug-releasing supplement therapy and novel viral therapy, cretostimogene grenadenorepvec."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Erratum: TAR-200 for Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study. (PubMed, J Clin Oncol) - No abstract available

Journal • P2b data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

New treatment eliminates bladder cancer in 82% of patients (Keck School of Medicine of USC) - "A new drug-releasing system, TAR-200, eliminated tumors in 82% of patients in a phase 2 clinical trial for individuals with high-risk non-muscle-invasive bladder cancer whose cancer had previously resisted treatment...To offer patients a better option, urologic oncologists treated patients with TAR-200 every three weeks for six months, and then four times a year for the next two years. In 70 out of 85 patients, the cancer disappeared and for almost half the patients, was still gone a year later. The treatment was well-tolerated, with minimal side effects....The study also showed that administering TAR-200 along with another immunotherapy drug (cetrelimab) did not prove as effective as TAR-200 on its own and had more side effects."

P2b data • Bladder Cancer

U.S. FDA approval of INLEXZO (gemcitabine intravesical system) set to transform how certain bladder cancers are treated (PRNewswire) - "INLEXZO, previously referred to as TAR-200, 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....The approval is supported by data from the SunRISe-1 (NCT04640623) single arm, open-label Phase 2b clinical study."

FDA approval • Bladder Cancer