Bladder Cancer
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Jul 20 – Jul 27, 2026
Enfortumab Vedotin and Pembrolizumab in Cisplatin-Eligible Bladder Cancer.
NEW ENGL J MED · Q1 JOURNAL - RANK #2/332TOP-TIER
This phase 3, open-label, randomized trial compared perioperative enfortumab vedotin plus pembrolizumab (EV+P) with neoadjuvant cisplatin-gemcitabine in cisplatin-eligible adults with muscle-invasive bladder cancer undergoing cystectomy. Participants received 4 neoadjuvant cycles of EV+P followed by cystectomy and adjuvant EV+P, or 4 neoadjuvant cycles of cisplatin-gemcitabine followed by cystectomy; primary endpoint was event-free survival (EFS), with overall survival (OS) and pathological complete response (pCR) as key secondary endpoints. Among 405 vs 403 participants and median follow-up 33.6 months, 2-year EFS was 79.4% vs 66.2% (HR 0.53, 95% CI 0.41–0.70; P<0.001), OS 86.9% vs 81.3% (HR 0.65, 95% CI 0.48–0.89; P=0.006), and pCR 55.8% vs 32.5% (P<0.001). Grade ≥3 adverse events were 75.7% with EV+P vs 67.2% with cisplatin-gemcitabine; EV+P improved EFS, OS, and pCR with higher toxicity.
10.1056/NEJMoa2601486
Higher rates of immune-related adverse events in circulating tumor DNA (ctDNA)-negative patients following adjuvant checkpoint inhibitor therapy.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This study prospectively compared muscle-invasive urothelial carcinoma patients (n=781) treated with adjuvant atezolizumab (n=384) or observation (n=397), analyzing associations between circulating tumor DNA (ctDNA) status and immune-related adverse events (irAEs) using Cox models, sensitivity analyses, and landmark analysis. The primary objective was to explore the relationship between ctDNA status and time to first irAE. Key findings included higher all-grade irAE rates in baseline ctDNA-negative AA patients versus positive (54.7% vs. 32.5%; HR 1.91, 95% CI: 1.25–2.90), and lower irAE rates with increasing ctDNA (HR 0.92 per log-MTM/ml, 95% CI: 0.87–0.97); discontinuation for adverse events was also higher in ctDNA-negative patients. The study concluded that ctDNA-negative patients receiving AA experienced more toxicity without survival benefit, suggesting ctDNA could inform treatment decisions.
10.1016/j.esmoop.2026.107701
Jul 06 – Jul 13, 2026
Long-term follow-up of a phase 1/2 trial of anti-GDF-15 antibody visugromab plus anti-PD-1 antibody nivolumab in anti-PD-1/-L1 relapsed/refractory solid tumors.
J HEMATOL ONCOL · Q1 JOURNAL - RANK #1/98TOP-TIER
This multicenter phase 1/2a clinical trial evaluated visugromab, an anti-GDF-15 antibody, plus nivolumab in 77 patients with anti-PD-1/PD-L1-relapsed/refractory locally advanced/metastatic non-squamous NSCLC, urothelial carcinoma, or hepatocellular carcinoma. Patients received both drugs every two weeks until progression or unacceptable toxicity, and responses were assessed via RECIST v1.1. Objective response rates were 18.2% (NSCLC), 18.5% (UC), and 14.3% (HCC), with median duration of response ranging from 19.4 to 32.2 months and 53.8% of responses ongoing; 61.5% achieved confirmed complete or metabolic response. The study concludes that GDF-15 blockade with visugromab enhances response rates and durability versus prior anti-PD-1/PD-L1 therapy, suggesting its value for further randomized investigation.
10.1186/s13045-026-01818-2
A phase Ib/II, open-label, multicenter, randomized umbrella study evaluating the combination of atezolizumab with sacituzumab govitecan in patients with locally advanced or metastatic urothelial carcinoma and previously treated with a platinum-based treatment regimen (MORPHEUS-Urothelial Carcinoma).
ESMO OPEN · Q1 JOURNAL - RANK #36/326
MORPHEUS-UC is a global, phase Ib/II, open-label, randomized umbrella trial in checkpoint inhibitor–naïve patients with platinum-treated locally advanced or metastatic urothelial carcinoma, comparing atezolizumab plus sacituzumab govitecan versus atezolizumab alone; primary endpoints were investigator-assessed ORR and safety, with secondary PFS, DOR, DCR, and OS. Fifteen patients received the combination and 30 received atezolizumab monotherapy. Confirmed ORR was 6.7% with the combination versus 27.6% with atezolizumab, and there was no improvement in ORR, PFS, or OS with the addition of sacituzumab govitecan. Treatment-related adverse events included anemia, neutropenia, pruritus, nausea, and alopecia with the combination, and pruritus, decreased appetite, rash, and fatigue with atezolizumab; no grade 5 TRAEs occurred, leading to the conclusion of limited rationale for further development of the combination in this setting.
10.1016/j.esmoop.2026.108303
Jun 22 – Jun 29, 2026
Identification of alpha1-oleate as a potent regulator of adipokine-dependent metabolism, in bladder cancer tissue.
CANCER METAB · Q1 JOURNAL - RANK #61/326
This prospective, double-blinded, placebo-controlled Phase II study aimed to evaluate intravesical alpha1-oleate’s effects on tumor metabolism in patients with non-muscle invasive bladder cancer. Participants received six instillations and underwent urine cell, tissue biopsy, and urine sample collection for RNA sequencing, transcriptomic, and adipokine analyses. Alpha1-oleate treatment significantly inhibited metabolic gene networks, particularly those linked to adiponectin (ADIPOQ) and leptin (LEP), alongside increased urinary adiponectin and leptin levels. The findings suggest potent metabolic modulation in tumor tissue and highlight this approach as a promising strategy to target key cancer regulators in superficial bladder tumors.
10.1186/s40170-026-00445-2
Tislelizumab combined with gemcitabine as first-line treatment in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma: a single center, single-arm phase 2 trial.
FRONT IMMUNOL · Q1 JOURNAL - RANK #32/183
This single-center, single-arm phase 2 trial evaluated gemcitabine plus tislelizumab in 30 cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma. The primary endpoints were objective response rate (ORR) and disease control rate (DCR), and secondary measures included progression-free survival (PFS) and overall survival (OS). The confirmed ORR was 46.7% (14/30), with a DCR of 76.7%, median PFS of 13.9 months (95% CI: 11.4–16.3), and median OS of 23.3 months ([IQR]: 14.4–33.1; 95% CI: 18.2–28.3). These findings suggest a potential role for this combination as a first-line therapeutic option for la/mUC patients who cannot receive cisplatin-containing regimens.
10.3389/fimmu.2026.1824893
Spatial architecture contributes to failure of bulk biomarker-guided neoadjuvant immunotherapy selection in bladder cancer: The DUTRENEO study.
CELL REP MED · Q1 JOURNAL - RANK #15/195TOP-TIER
The study aimed to test the prospective utility of a validated 18-gene bulk tumor inflammation signature for guiding neoadjuvant immune checkpoint inhibitor therapy in muscle-invasive bladder cancer. Conducted as the randomized phase 2 DUTRENEO trial (EudraCT 2017-002246-68), it included single-cell spatial transcriptomic profiling of 377 genes across ~5.4 million cells. Though the trial did not meet its primary endpoint, it revealed that bulk gene-expression was insufficient to predict treatment response. Instead, localized T cell-cancer cell interactions and fibroblast-dense immune-excluded areas were critical to therapy outcomes, highlighting the need for advanced spatial biomarkers.
10.1016/j.xcrm.2026.102878
Early Efficacy and Exploratory Biomarker Data of Bel-sar in Patients with Intermediate-risk and High-risk Non-muscle-invasive Bladder Cancer.
EUR UROL OPEN SCI · Q1 JOURNAL - RANK #16/133
Phase 1 prospective trial in intermediate- and high-risk NMIBC evaluated safety, feasibility, preliminary efficacy, and immune biomarkers of bel-sar. Seventeen patients received focal intratumoral bel-sar (100–200 µg) without (n=5) or with (n=12) light activation, followed by TURBT 7–12 days later; multiplex immunofluorescence was done on paired tumors from five responders. Bel-sar was well tolerated with only grade 1 adverse events and no grade ≥2, serious, or dose‑limiting toxicities. Among 10 efficacy‑evaluable light‑activated patients, four of five low‑grade tumors achieved complete response; responses were also seen in high‑grade and untreated tumors, with immune conversion to immunogenically primed states (tertiary lymphoid structures, cytotoxic and memory CD4+ T‑cell expansion, NK cell and eosinophil recruitment), supporting further development.
10.1016/j.euros.2026.05.017
Phase 2 Trial of Intravesical Gemcitabine and Docetaxel as First-Line Treatment of Bacillus Calmette-Guérin (BCG)‒Naïve Nonmuscle-Invasive Urothelial Carcinoma: Updated, 3-Year Outcomes.
J UROLOGY · Q1 JOURNAL - RANK #10/133
This study is a single-arm, open-label phase 2 clinical trial investigating the efficacy and safety of intravesical gemcitabine-docetaxel (Gem/Doce) as a first-line treatment for BCG-naïve high-risk nonmuscle-invasive bladder cancer (HR NMIBC). Twenty-five patients were enrolled from August 2020 to August 2022, receiving 6 weeks of Gem/Doce induction therapy followed by 2 years of monthly maintenance, with a median follow-up of 50 months. High-grade recurrence-free survival (RFS) rates were 84% at 24 months (95% CI: 63%-94%) and 80% at 36 months (95% CI: 58%-91%), with no progression during treatment and grade-3 adverse events in 20% of participants. These results demonstrate the efficacy, durability, and manageable safety profile of Gem/Doce in treating BCG-naïve HR NMIBC over three years of follow-up.
10.1097/JU.0000000000005179
Jun 15 – Jun 22, 2026
Tremelimumab with or without durvalumab in combination with paclitaxel in metastatic urothelial cancer: phase I/II ICRA trial.
NAT COMMUN · Q1 JOURNAL - RANK #10/135TOP-TIER
This multicenter, open-label, phase Ib-II ICRA clinical trial (NCT03871036) investigated whether paclitaxel plus tremelimumab, with or without durvalumab, could induce a tumor response in patients with therapy-refractory metastatic urothelial carcinoma following prior treatments. Patients randomly received three different regimen arms with the main outcome measure being objective response rate, and secondary endpoints including safety, duration of response, and survival. The best response rate was observed in arm A (26%, 88% CI=[14,36%]), with grade 3-4 treatment-related adverse events reported in (A) 45%, (B) 75%, and (C) 25% of patients, respectively. These results demonstrate the potential for paclitaxel plus high-dose anti-CTLA-4 to activate meaningful tumor regression in mUC, indicating that immune stimulation may remain viable after anti–PD-(L)1 treatment.
10.1038/s41467-026-74570-3
Jun 08 – Jun 15, 2026
Avelumab first-line maintenance for advanced urothelial carcinoma: long-term outcomes from the JAVELIN Bladder 100 trial in patients with high body mass index or diabetes mellitus.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This phase III JAVELIN Bladder 100 trial evaluated avelumab first-line maintenance in advanced urothelial carcinoma for patients with high BMI (≥30) or controlled diabetes mellitus. In this prospective, randomized study, 700 participants without progression on platinum-based chemotherapy were randomized to receive avelumab plus best supportive care (BSC) or BSC alone. Hazard ratios for overall survival favored avelumab plus BSC over BSC alone in both high-BMI (HR=0.77 [95% CI 0.49-1.21]) and DM (HR=0.60 [95% CI 0.37-0.95]) subgroups. These results support the long-term safety and efficacy of avelumab in these metabolic-risk populations.
10.1016/j.esmoop.2026.107776
Jun 01 – Jun 08, 2026
Neoadjuvant Sacituzumab Govitecan in Patients With Muscle-Invasive Bladder Cancer: Primary Results of the SURE-01 Trial.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This phase II, single-arm SURE-01 trial evaluated neoadjuvant sacituzumab govitecan (SG) in patients with cT2–T4aN0M0 muscle-invasive bladder cancer ineligible for or refusing neoadjuvant chemotherapy, administering four 3-week cycles (initially 10 mg/kg on days 1 and 8, then amended to 7.5 mg/kg) followed by radical cystectomy (RC); baseline tumors underwent transcriptome-wide and genomic profiling. Among 44 treated, two early deaths (one treatment-related) prompted dose reduction and neutropenia prophylaxis; subsequent grade 3–4 treatment-related adverse events occurred in 5 patients (13.9%). In the intention-to-treat population, the protocol-defined ypT0N0 rate was 9.1% (95% CI, 2.5–21.7), the overall ypT0N0-x rate was 29.5% (95% CI, 16.7–45.2), and 24-month event-free survival was 71.4% (95% CI, 58–87.8); nonluminal subtypes showed higher ypT0 (46% vs 14% luminal). The study concludes SG at 7.5 mg/kg is active with manageable safety and supports TROP2 targeting; lower TOP1 expression correlated with longer EFS.
10.1200/JCO-26-00142
May 25 – Jun 01, 2026
Addition of Intravesical Recombinant BCG to Perioperative Chemo-Immunotherapy in Muscle-Invasive Bladder Cancer: Primary Analysis of the Single-Arm Phase 2 Trial SAKK 06/19.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This open-label, single-arm phase II trial (SAKK 06/19) evaluated neoadjuvant intravesical recombinant BCG (VPM1002BC) added to atezolizumab and cisplatin/gemcitabine in cT2–T4a N0–1 muscle-invasive bladder cancer, followed by radical cystectomy with lymphadenectomy. rBCG was instilled weekly for three doses beginning day 1; atezolizumab was given on day 1 for four doses; chemotherapy started day 22 for four cycles; adjuvant atezolizumab was reserved for >yT1 ypN0. Among 47 enrolled patients (95% received rBCG; 78% completed all three doses), centrally reviewed pCR was 68% (27/40; one-sided 95% CI lower bound 53%) and PaR was 83% (33/40; 95% CI 67–93); seven did not undergo surgery. Treatment-related adverse events were 42%/9%/0% (any/grade 3/grade 4) for rBCG, 55%/15%/2% for atezolizumab, and 96%/38%/17% for chemotherapy; investigators conclude high response rates warrant randomized trials.
10.1200/JCO-26-00845
AI-MIRACLE: Artificial Intelligence and MultIpaRAmetric MRI Predict CLinical OutcomEs to Neoadjuvant Immunotherapy in Patients with Muscle-invasive Bladder Cancer Undergoing Radical Cystectomy.
EUR UROL ONCOL · Q1 JOURNAL - RANK #7/133
This multi-institutional study analyzed data from 112 patients in the PURE-01 trial (NCT02736266), a prospective study evaluating neoadjuvant pembrolizumab before radical cystectomy in cisplatin-ineligible muscle-invasive bladder cancer patients. Pre- and post-immunotherapy multiparametric MRI data were processed using radiomics (pyCERR) and deep feature extraction (AI-BLADE/VGG19), with supervised machine learning (elastic net, random forest) used to predict pathological response. The post-ICI mpMRI radiomics model achieved an AUC of 0.96 for major pathological response (ypT<2N0), while a shape-based radiomics model achieved an AUC of 0.86 for pathological complete response (ypT0). The authors concluded that these imaging biomarkers provide noninvasive assessment of treatment response, potentially guiding bladder-preserving strategies before definitive surgery.
10.1016/j.euo.2026.05.006
Blood Pressure Changes After Oral 5-Aminolevulinic Acid Hydrochloride Administered 4-8 h Before TURBT: An Additional Analysis of a Phase III Study (SPP2C102).
LIFE-BASEL · Q1 JOURNAL - RANK #22/107
This prospective phase III study assessed blood pressure changes and hypotension-related adverse drug reactions after oral 5-aminolevulinic acid hydrochloride administration in patients undergoing transurethral resection of bladder tumor (TURBT). Blood pressure was monitored for 24 hours post-dose, with hypotension-related ADRs assessed within 14 days, and photodynamic diagnosis sensitivity compared under blue versus white light (95.3% vs. 61.1%, p < 0.001). The nadir in blood pressure occurred 2 hours after dosing, with hypotension (≤ 80 mmHg) observed in 2.1% of patients—much lower than prior retrospective studies—and 25.5% experiencing non-serious, resolved ADRs. The study concludes the lower incidence of hypotension may result from protocol-controlled exclusion criteria and medication restrictions.
10.3390/life16050819
Neoadjuvant Durvalumab ± Tremelimumab in Combination With Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Muscle-Invasive Bladder Carcinoma: Results of the Phase I/II NEMIO Study.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
Using a multicenter, randomized, noncomparative phase II design, the study aimed to evaluate efficacy and safety of neoadjuvant ddMVAC combined with durvalumab or durvalumab plus tremelimumab in muscle-invasive bladder carcinoma. Participants received ddMVAC once every two weeks for four cycles plus two doses of immunotherapy prior to radical cystectomy. The overall Bayesian posterior mean pathologic complete response (pCR) rate was 48.70% (doublet) versus 46.27% (triplet), with higher pCR in PD-L1-high tumors (68.25% vs 33.49%). Both regimens showed favorable early survival outcomes, although the triplet presented higher toxicity, indicating ddMVAC plus durvalumab as a promising neoadjuvant option for future comparative trials.
10.1200/JCO-25-03045