Bladder Cancer
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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
May 18 – May 25, 2026
Bladder Adjuvant Radiotherapy: Phase III Multicenter Randomized Controlled Trial of Adjuvant Radiotherapy or Observation for Postcystectomy Muscle-Invasive Bladder Cancer.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
Objective: assess adjuvant radiotherapy (RT) after chemotherapy and radical cystectomy (RC) in high-risk muscle-invasive bladder cancer (MIBC) in a multicenter, phase III randomized trial. Patients (n=153; pT3–4 62%, pN+ 41%) were randomized 1:1 to stoma-sparing IG-IMRT 50.4 Gy/28 fractions to cystectomy bed/pelvic nodes versus observation, stratified by nodal status and chemotherapy; >90% received perioperative chemotherapy (71% neoadjuvant, 20% adjuvant). After median 47 months, 2-year LRFS was 87.1% vs 76.0% (HR 0.43, 95% CI 0.20–0.96, p=0.04); DFS 71.6% vs 58.7% (HR 0.62, 95% CI 0.36–1.05), BCSS 79.6% vs 65.0% (HR 0.59, 95% CI 0.33–1.10), and OS 70.4% vs 57.4% (HR 0.78, 95% CI 0.49–1.26). The authors conclude adjuvant pelvic IMRT improves locoregional control without added severe toxicity, with nonsignificant trends toward improved DFS/BCSS/OS.
10.1200/JCO-25-02093
EV-103 dose escalation/cohort A: 5-year follow-up of enfortumab vedotin plus pembrolizumab in previously untreated locally advanced/metastatic urothelial carcinoma.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This phase Ib/II EV-103/KEYNOTE-869 study evaluated enfortumab vedotin (EV) plus pembrolizumab (P) in cisplatin-ineligible patients with previously untreated locally advanced/metastatic urothelial carcinoma (la/mUC). Forty-five patients received EV 1.25 mg/kg on days 1 and 8 and pembrolizumab 200 mg on day 1 of 3-week cycles, with a primary endpoint of safety and secondary endpoints including ORR, DOR, PFS, and OS. After a median 62.1-month follow-up, the confirmed ORR was 73.3%, median DOR was 22.1 months, median PFS was 12.7 months, median OS was 26.1 months, and the estimated 5-year survival rate was 41.5%. The authors conclude that these results support EV+P as standard of care in this population.
10.1016/j.esmoop.2026.107700
Apr 20 – Apr 27, 2026
Camrelizumab Plus Nab-paclitaxel in Patients with Previously Treated Advanced Urothelial Carcinoma: A Multicenter Phase II Study.
CANCER COMMUN · Q1 JOURNAL - RANK #12/326TOP-TIER
This multicenter phase II study evaluated the efficacy and safety of camrelizumab plus nab-paclitaxel in patients with previously treated advanced urothelial carcinoma (aUC). Sixty patients, who had received at least one platinum-based therapy, were treated with camrelizumab and nab-paclitaxel on a 21-day cycle until disease progression or unacceptable toxicity. The median progression-free survival (PFS) was 4.66 months (95% CI, 4.13–8.50) for the full analysis set, with a median overall survival of 15.70 months (95% CI, 12.17–NR) and an objective response rate of 37.04%. The study concluded that camrelizumab plus nab-paclitaxel exhibited modest antitumor activity with manageable toxicity, with 98.33% of patients experiencing adverse events and 51.67% reporting grade ≥3 events.
10.34133/cancomm.0025
Gemcitabine plus nivolumab with carboplatin or oxaliplatin in cisplatin-ineligible patients with metastatic urothelial carcinoma: a randomized phase II trial.
CLIN CANCER RES · Q1 JOURNAL - RANK #29/326TOP-TIER
This randomized phase II trial compared gemcitabine/carboplatin versus gemcitabine/oxaliplatin, both combined with nivolumab, in cisplatin-ineligible metastatic urothelial carcinoma patients using a pick-the-winner design. Forty-nine patients were randomized 1:1, with objective response rates of 69.6% (95% CI 0.48-0.87) for carboplatin and 33.3% (95% CI 0.15-0.57) for oxaliplatin, and median overall survival of 24.74 versus 16.43 months respectively (HR 1.99, p=0.07). Exploratory biomarker analyses showed sustained adaptive immune activation with carboplatin versus tumor-promoting inflammation with oxaliplatin. The study concluded oxaliplatin-based chemo-immunotherapy did not yield higher response rates than carboplatin-based therapy, challenging preclinical assumptions.
10.1158/1078-0432.CCR-26-0469
Apr 06 – Apr 13, 2026
Pembrolizumab in Combination With Gemcitabine and Concurrent Hypofractionated Radiation Therapy as Bladder-sparing Treatment for Muscle-invasive Urothelial Cancer of the Bladder: A Multicenter Phase 2 Trial.
EUR UROL · Q1 JOURNAL - RANK #3/133TOP-TIER
The study evaluated the safety and efficacy of adding pembrolizumab to trimodality therapy (TMT) for muscle-invasive bladder cancer (MIBC) in a multicenter phase 2 trial. Fifty-four patients received pembrolizumab followed by maximal transurethral resection, concurrent low-dose gemcitabine, and radiation, with 48 in the efficacy cohort; 67% had clinical stage T2 disease. The 2-year bladder-intact disease-free survival (BIDFS) was 60% (95% CI, 45-73), metastasis-free survival (MFS) was 81% (95% CI, 66-92), and overall survival (OS) was 83% (95% CI, 69-91), with grade ≥3 adverse events in 25% of patients. The study concluded that pembrolizumab combined with gemcitabine-based chemoradiation was feasible and showed efficacy comparable to standard TMT, with ongoing phase 3 trials to further define its role.
10.1016/j.eururo.2026.02.016