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

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

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

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

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) - P2 | "TAR-200 monotherapy was well tolerated, with a high CR rate, durable responses, and prolonged DFS in patients with BCG-unresponsive high-risk NMIBC. TAR-200 monotherapy offered a more favorable risk-benefit profile versus TAR-200 plus cetrelimab or cetrelimab alone in BCG-unresponsive CIS."

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

Top advances of the year: Bladder cancer. (PubMed, Cancer) - "TAR-200 is a new intravesical drug-delivery system that enables controlled release of gemcitabine but may be used with other anticancer drugs to treat nonmuscle-invasive bladder cancer and MIBC. Two phase 3 studies of adjuvant ICI (nivolumab and pembrolizumab) have both reported a doubling of disease-free survival in patients with high-risk MIBC receiving therapy. Perioperative durvalumab, including neoadjuvant therapy plus gemcitabine and cisplatin before radical cystectomy followed by adjuvant durvalumab, demonstrated an improvement in event-free survival and overall survival for patients with MIBC. Circulating tumor DNA is a promising biomarker to select patients with MIBC for adjuvant ICI therapy. Finally, the combination of enfortumab vedotin, an antibody-drug conjugate, plus pembrolizumab doubled overall survival compared with standard gemcitabine plus platinum in patients with metastatic urothelial carcinoma and has been implemented in treatment guidelines in the..."

Biomarker • IO biomarker • Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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

P2s: Practice-changing, Paradigm-shifting Clinical Trials in Urology (P2): 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 (AUA 2025) - P2 | "First results of TAR-200 monotherapy in patients with BCG-unresponsive papillary disease–only HR NMIBC in SunRISe-1 demonstrated the highest DFS rates reported in this setting. TAR-200 monotherapy was well tolerated with a favorable safety profile. These results support ongoing development of TAR-200 monotherapy for treatment of BCG-unresponsive papillary disease–only HR NMIBC."

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

P2s: Practice-changing, Paradigm-shifting Clinical Trials in Urology (P2): 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 (AUA 2025) - P2 | "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. Overall health status and high PF were maintained on TAR-200 treatment."

Clinical • Monotherapy • Patient reported outcomes • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

TAR-200 plus cetrelimab versus cetrelimab monotherapy as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or decline neoadjuvant cisplatin-based chemotherapy (SunRISe-4): interim analysis of a randomised, open-label phase 2 trial. (PubMed, Lancet Oncol) - P2 | "Neoadjuvant TAR-200 plus cetrelimab showed a high pathological complete response rate with a manageable safety profile. These results support continued investigation of TAR-200 in patients with muscle-invasive bladder cancer planned for radical cystectomy."

Journal • Monotherapy • P2 data • Bladder Cancer • Diabetes • Genito-urinary Cancer • Oncology • Solid Tumor

Evolving Pharmacotherapy for Bladder Cancer-From Non-Muscle-Invasive to Metastatic Disease-Development of Novel Therapies for BCG-Unresponsive NMIBC (PubMed, Gan To Kagaku Ryoho) - "Bladder cancer is a common malignancy in the elderly, with approximately 75% of cases diagnosed as non-muscle-invasive bladder cancer(NMIBC).Although transurethral resection of bladder tumor(TURBT)is the standard initial treatment, recurrence rates remain high, and intravesical Bacillus Calmette-Guérin(BCG)instillation has long been used as an adjuvant therapy.However, about 30% of patients develop BCG-unresponsive disease despite adequate BCG administration.Radical cystectomy is recommended in such cases, but its invasiveness and impact on quality of life(QOL)often make it impractical in real-world settings.Thus, the development of novel bladder-preserving treatments is urgently needed.In recent years, diverse approaches including immune checkpoint inhibitors(ICI), gene therapy, drug delivery systems(DDS), and oncolytic virus-based therapies have been actively investigated, with numerous clinical trials ongoing worldwide.Importantly, pembrolizumab, nadofaragene..."

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

Inlexzo: Regulatory submissions in US/EU for high-risk NMIBC (based on SunRise-5 trial) in 2026 (J&J) - Q4 2025 Results

EMA filing • FDA filing • Bladder Cancer • Genito-urinary Cancer • Oncology • Urothelial Cancer

Inlexzo: Data from P3 SunRISe-5 trial (NCT06211764) for high-risk NMIBC in 2026 (J&J) - Q4 2025 Results

P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Urothelial Cancer

SAFETY AND TOLERABILITY OF TAR-200 MONOTHERAPY IN PATIENTS WITH BACILLUS CALMETTE–GUÉRIN (BCG)-UNRESPONSIVE HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER (HR NMIBC) IN SUNRISE-1 (SUO 2024) - P2 | "SunRISe-1 (SR-1; NCT04640623) is an ongoing, phase 2b study assessing the efficacy and safety of TAR-200 + cetrelimab (anti-PD1) (Cohort 1 [C1]), TAR-200 alone (C2), or cetrelimab alone (C3) in patients with BCG-unresponsive HR NMIBC ineligible for or refusing radical cystectomy. TAR-200 monotherapy was well tolerated in SR-1, with a high rate of insertion success and a median indwelling duration of 22 days. Commonly reported lower urinary tract related TRAEs were manageable and resolved after a short duration. TAR-200 has a promising safety and efficacy profile as a local, bladder-sparing treatment in HR NMIBC unresponsive to BCG."

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

SunRISe-5: A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF TAR-200 COMPARED WITH INTRAVESICAL CHEMOTHERAPY AFTER BACILLUS CALMETTE-GUÉRIN IN RECURRENT HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER (AUA 2025) - P3 | "Patients (N = 250) will be stratified based on T stage and prior BCG treatment and will be randomized 1:1 to receive TAR-200 every 3 weeks through Week 24, then every 12 weeks from Week 36 through Week 99 or to receive investigator's choice of intravesical mitomycin C or gemcitabine weekly during induction and monthly during the maintenance phases. Secondary end points include recurrence-free survival, time to next intervention, time to disease worsening, time to progression, overall survival, safety and tolerability, and patient-reported health-related quality of life outcomes. As of January 30, 2025, 181 patients have been randomized, and recruitment is ongoing at 122 sites."

Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial. (PubMed, Urol Oncol) - P1b | "Controlled intravesical gemcitabine release via TAR-200 was safe and well tolerated in patients with MIBC."

Journal • P1 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urinary Incontinence • Urology • Urothelial Cancer

SunRISe-4: TAR-200 plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant platinum-based chemotherapy. (ASCO-GU 2023) - P2 | "As of September 12, 2022, 2 of 160 planned pts have been enrolled and randomized, and recruitment is ongoing at ≈95 sites. Clinical trial information: NCT04919512."

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

Safety, Tolerability, and Preliminary Efficacy of TAR-200 in Patients With Muscle-invasive Bladder Cancer Who Refused or Were Unfit for Curative-intent Therapy: A Phase 1 Study. (PubMed, J Urol) - "TAR-200 was generally safe, well tolerated, and had beneficial preliminary efficacy in this elderly and frail cohort with limited treatment options."

Journal • P1 data • Bladder Cancer • Genito-urinary Cancer • Geriatric Disorders • Oncology • Solid Tumor • Urothelial Cancer

First Results From SunRISe-1 in Patients With BCG Unresponsive High-Risk Non–muscle-Invasive Bladder Cancer Receiving TAR-200 in Combination With Cetrelimab, TAR-200, or Cetrelimab Alone (AUA 2023) - "First results from SunRISe-1 show promising CR rate and safety profile with TAR-200 monotherapy, and CET results are consistent with other anti-PD(L)1 tx in this setting. Preliminary efficacy and safety data support the continued study in NMIBC."

Clinical • Combination therapy • Late-breaking abstract • Bladder Cancer • Cardiovascular • Fatigue • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Results from SunRISe-1 in patients (Pts) with bacillus Calmette–Guérin (BCG)-unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC) receiving TAR-200 monotherapy (ESMO 2023) - P2b | "SunRISe-1 (NCT04640623) is an ongoing, randomized, ph 2b study assessing efficacy and safety of TAR-200 + cetrelimab (anti-PD1) (Cohort 1 [C1]), TAR-200 alone (C2), or cetrelimab alone (C3) in pts with BCG-unresponsive HR NMIBC ineligible for or refusing radical cystectomy. No deaths were reported. Conclusions In SunRISe-1, TAR-200 monotherapy is associated with an unprecedented CR rate, durable responses, and a favorable tolerability profile in pts with BCG-unresponsive CIS, supporting its continued investigation in HR NMIBC."

Clinical • Late-breaking abstract • Monotherapy • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SunRISe-3: TAR-200 plus cetrelimab or TAR-200 versus intravesical Bacillus Calmette–Guérin in patients with BCG-naive high-risk non–muscle-invasive bladder cancer (EAU 2024) - No abstract available

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

P2s: Paradigm-shifting, Practice-changing Clinical Trials in Urology: TAR-200 in patients with Bacillus Calmette–Guérin-unresponsive high-risk non–muscle-invasive bladder cancer: Results from SunRISe-1 study (AUA 2024) - No abstract available

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

TAR-200 IN PATIENTS WITH BACILLUS CALMETTE-GUERIN-UNRESPONSIVE HIGH-RISKNONeMUSCLE-INVASIVE BLADDER CANCER: RESULTS FROM SUNRISE-1 STUDY (AUA 2024) - P2 | "SunRISe-1(NCT04640623) is an ongoing, randomized, phase 2b study assessing efficacy and safety of TAR-200þcetrelimab (anti-PD1) (Cohort 1 [C1]),TAR-200 alone (C2), or cetrelimab alone (C3) in pts with BCG-unresponsive HR NMIBC with carcinoma in situ (CIS), with or without papillary disease, who are ineligible for or refusing radical cystectomy. In SunRISe-1, TAR-200 monotherapy is associated with a clinically meaningful, high, centrally confirmed CRrate, durable responses, and a favorable benefit-risk profile in pts withBCG-unresponsive CIS."

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

TAR-200 +/- cetrelimab (CET) and CET alone in patients (pts) with bacillus Calmette-Guérin-unresponsive (BCG UR) high-risk non-muscle-invasive bladder cancer (HR NMIBC): Updated results from SunRISe-1 (SR-1) (ESMO 2024) - P2 | "TAR-200 monotherapy is highly effective, with the highest single agent CR rate based on published data to date in pts with BCG UR HR NMIBC, durable responses and low d/c rate from TRAEs. CET alone provided modest CR rate comparable to other anti-PD-(L)1 agents. Results from C1, C2, and C3 support the continued development of TAR-200 monotherapy in pts with BCG UR HR NMIBC."

Clinical • Late-breaking abstract • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

TAR-200 plus cetrelimab (CET) or CET alone as neoadjuvant therapy in patients (pts) with muscle-invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant cisplatin-based chemotherapy (NAC): Interim analysis of SunRISe-4 (SR-4) (ESMO 2024) - P2 | "TAR-200 + CET neoadjuvant therapy revealed compelling pCR and pOR rates, with a manageable safety profile, supporting the addition of TAR-200 to anti-PD-1 tx in pts with MIBC. In the cT2 subgroup, >2/3 pts who received TAR-200 + CET tx were downstaged to ≤ T1 at RC and ∼1/2 pts achieved pCR. SR-4 interim results support further investigation of TAR-200 + CET in pts with MIBC."

Clinical • Late-breaking abstract • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Association of PD-L1 expression with clinical response to TAR-200 in the phase IIb SunRISe-1 trial (ESMO 2024) - P2 | "SunRISe-1 (NCT04640623) is an ongoing randomized, phase 2b study assessing efficacy and safety of TAR-200 + cetrelimab (CET) (anti-PD1) (Cohort 1 [C1]), TAR-200 alone (C2), or CET alone (C3) in pts with BCG-unresponsive high-risk (HR) NMIBC with carcinoma in situ (CIS), with or without papillary disease, who are ineligible for or refusing radical cystectomy. In this study of SunRISe-1 PD-L1 expression limited by small sample size and number of clinical events, we observed high clinical response to TAR-200 monotherapy in HR NMIBC pts with BCG-unresponsive CIS irrespective of PD-L1 status."

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