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

Phase 1/2 Study Of PARP Inhibition With Olaparib To Enhance The Efficacy Of High-Dose Chemotherapy In Refractory And Relapsed Germ Cell Tumors (clinicaltrials.gov) - P1/2 | N=36 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P1/2 trial • Germ Cell Tumors • Oncology • CD34

Complete Response Durability After TAR-200 and Nadofaragene Firadenovec in BCG-unresponsive Bladder CIS. (PubMed, Anticancer Res) - P3 | "In this exploratory rIPD-based cross-trial analysis, CR durability among responders did not differ significantly between TAR-200 and nadofaragene firadenovec through 24 months. Later RMST point estimates and model-based durable CR fraction estimates were numerically higher for TAR-200, but these findings require cautious interpretation because of cross-trial comparability limitations, responder-conditioned selection, and limited follow-up."

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

Gemcitabine intravesical system (Gem-iDRS) in combination with cetrelimab (CET) versus chemoradiotherapy (CRT) in muscle-invasive bladder cancer (MIBC): SunRISe-2 final results. (ASCO-GU 2026) - P3 | "Gem-iDRS (previously TAR-200), approved for BCG-unresponsive non-MIBC with carcinoma in situ, is an intravesical drug-releasing system designed for sustained delivery of gemcitabine in bladder... Patients (pts; ≥18 yrs with cT2-T4a, N0, M0 MIBC, declined/ineligible for RC) were randomized 1:1 to Gem-iDRS + intravenous CET (arm 1) or concurrent CRT (cisplatin or gemcitabine plus RT, 64 or 55 Gy; arm 2)... In SunRISe-2, Gem-iDRS + CET did not show superior BI-EFS over CRT in pts with MIBC not receiving RC. 24-mo BI-EFS rates in pts with CR at W18, and MFS and OS rates in all pts were similar in both arms. There were no unexpected safety findings in either arm."

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

Trial design drives outcomes: harmonising efficacy across BCG-unresponsive bladder carcinoma in situ trials. (PubMed, BJU Int) - "Trial design artefacts significantly impact reported efficacy in BCG-U CIS studies. Published CR rates are not directly comparable across agents. Future trials should standardise biopsy timing and clearly define retreatment policies to ensure meaningful cross-study comparisons."

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

THE GAIN TRIAL: Gemcitabine Alternating with INtravesical BCG randomized against BCG alone for patients with recurrent "BCG-exposed" high grade NMIBC (ALLIANCE A032303/ NCT07000084) (AUA 2026) - P1/2, P3 | "gemcitabine plus docetaxel) or TAR-200.Any prior treatment with any systemic or intravesical agents for NMIBC is allowed, regardless of whether it is given either alone or in prior combination with BCG (ie. Prior treatment with pembrolizumab, sasanlimab, durvalumab, other immune checkpoint inhibitors, nadofaragene firadenovec, nogapendekin alfa inbakicept, cretostimogene grenadenorepvec, etc.) are all allowed...Notable exclusion criteria include current/prior MIBC and prior intolerance to BCG or any other intravesical therapy. Other notable aspects of the trial include: (1) the reduced burden on investigators & research teams due to the NCI's new streamlined data initiative, (2) pragmatic inclusion/exclusion criteria and pragmatic design to improve generalizability of results, and (3) cystoscopic biopsies/TURBT at week 13/month 3 for all participants (both CIS & "papillary only") for multiple reasons including to allow for earlier..."

Clinical • IO biomarker • Bladder Cancer • Prostate Cancer • Urothelial Cancer

Nova-sTAR: A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States (clinicaltrials.gov) - P=N/A | N=150 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2029 ➔ Jun 2030

Real-world evidence • Trial completion date • 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 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

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

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

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

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 genomic disease burden markers and programmed death-ligand 1 with clinical outcomes in patients with muscle-invasive bladder cancer treated with gemcitabine intravesical system + cetrelimab (CET) or CET alone in the Phase 2 SunRISe (AUA 2026) - P2 | "Source of Funding: Johnson & Johnson INTRODUCTION AND OBJECTIVES: Previous SunRISe-4 analyses (NCT04919512) demonstrated that Gemcitabine Intravesical System (Gem-iDRS; formerly TAR-200) + CET achieved high pathologic complete response (pCR), pathologic overall response (pOR), and 1-year recurrence free survival (RFS). High TMB, GDB and PD-L1 were all associated with higher pOR rates in muscle invasive bladder cancer (MIBC) pts in the overall cohort or with GEM iDRS+CET in the SunRISe-4 study. These findings warrant further investigation in a larger study to assess the potential utility of these biomarkers."

Clinical • Clinical data • IO biomarker • P2 data • Tumor mutational burden • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • MLH1 • MSH2 • MSH6 • PD-L1 • PMS2 • TMB

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

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

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

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

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

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

TAR-200 plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or refuse neoadjuvant platinum-based chemotherapy: interim analysis of SunRISe-4 (IBCN 2024) - No abstract available

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

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

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

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

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

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

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