Bladder Cancer
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Oct 05 – Oct 12, 2026
Disitamab Vedotin Plus Tislelizumab in Transurethrally Unresectable, ERBB2-Positive, Non-Muscle-Invasive Bladder Cancer: A Nonrandomized Clinical Trial.
JAMA ONCOL · Q1 JOURNAL - RANK #14/326TOP-TIER
This open-label, single-arm, phase 2 nonrandomized clinical trial evaluated disitamab vedotin plus tislelizumab in 28 adults with transurethrally unresectable ERBB2-positive very high-risk non-muscle-invasive bladder cancer who were ineligible for or declined cystectomy. Patients received intravenous disitamab vedotin (120 mg) plus tislelizumab (200 mg) every 3 weeks for 3 cycles, with responders receiving up to 8 and 17 cycles respectively. Complete response of high-risk disease occurred in 19 of 26 efficacy-evaluable patients (73.1%; 95% CI, 54.8%-91.3%), meeting the prespecified 70% alternative-rate goal, with 24-month sustained response of 83.5% among responders and no muscle-invasive or metastatic progression. The authors conclude that this combination may yield high complete response rates and durable disease control, supporting future randomized trials.
10.1001/jamaoncol.2026.3909
Sep 28 – Oct 05, 2026
A Phase I Clinical Trial of Chemoimmunotherapy with Alternating Intravesical Gemcitabine and Bacillus Calmette-Guérin (GemBCG) for BCG-Exposed High-Grade Non-Muscle-Invasive Bladder Cancer.
J UROLOGY · Q1 JOURNAL - RANK #10/133
This Phase I dose-escalation trial evaluated intravesical chemoimmunotherapy with gemcitabine and BCG (GemBCG) in 25 patients with BCG-exposed high-grade non-muscle-invasive bladder cancer. The primary objective was to define the maximally tolerated dose using a modified continual reassessment method, with gemcitabine escalated from 500-2000 mg and BCG given at 50 mg TICE. No treatment-related grade ≥3 adverse events or dose-limiting toxicities occurred, and 24 of 25 patients (96%; 95% CI 80%-100%) achieved a complete clinical response at 6-months. The authors conclude that GemBCG was safe, well-tolerated, and demonstrated promising early efficacy with immune microenvironment modification.
10.1097/JU.0000000000005324
Full enrollment results from cohort 1 of the phase III randomized THOR trial of erdafitinib versus chemotherapy in FGFR-altered advanced urothelial carcinoma.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This phase III randomized THOR trial evaluated erdafitinib versus investigator-choice chemotherapy (docetaxel or vinflunine) in 278 adults with metastatic urothelial carcinoma harboring susceptible FGFR3/2 alterations who progressed after anti-PD-(L)1 therapy. Patients were randomized 1:1, with overall survival as the primary endpoint and progression-free survival and objective response rate as key secondary endpoints. At final analysis (median follow-up 21.0 vs 18.0 months), erdafitinib significantly improved median OS (12.1 vs 8.7 months; HR 0.65, 95% CI 0.48–0.86; P=0.0031), PFS (5.4 vs 2.7 months; HR 0.59, 95% CI 0.45–0.77; P<0.0001), and ORR (46.9% vs 12.6%; RR 3.74, 95% CI 2.31–6.04; P<0.001). Grade 3–4 treatment-emergent adverse events were similar (67.6% vs 65.8%), but erdafitinib had fewer treatment-related serious AEs (12.7% vs 24.8%), treatment-related deaths (0.7% vs 6.0%), and discontinuations (9.2% vs 14.5%).
10.1016/j.esmoop.2026.108583
Sep 21 – Sep 28, 2026
Phase 1 study of KHK2455, a long-acting, potent and selective IDO1 inhibitor, in combination with avelumab in patients with locally advanced or metastatic urothelial carcinoma.
J IMMUNOTHER CANCER · Q1 JOURNAL - RANK #12/183TOP-TIER
This multicenter, open-label Phase 1 trial evaluated the safety, tolerability, pharmacokinetics, and antitumor activity of the oral IDO1 inhibitor KHK2455 combined with the PD-L1 inhibitor avelumab in adults with locally advanced or metastatic urothelial carcinoma. Sixteen subjects were enrolled across KHK2455 doses of 30, 100, and 200 mg plus avelumab 800 mg biweekly. No treatment-related TEAEs occurred, but four subjects had fatal TEAEs deemed unrelated; one complete response and one partial response were observed. The favorable safety profile and preliminary efficacy, supported by translational biomarker findings, warrant further investigation.
10.1136/jitc-2026-015178
Aug 24 – Aug 31, 2026
Urinary protein semi-quantification in immunochemotherapy for bladder cancer: markers of clinical outcomes.
FRONT IMMUNOL · Q1 JOURNAL - RANK #32/183
This study conducted a secondary analysis of the TRUCE-01 and TRUCE-02 interventional clinical trials to investigate the association between urinary protein semi-quantification (UPSQ) and clinical outcomes in 104 bladder cancer patients receiving tislelizumab plus nab-paclitaxel immunochemotherapy. Dynamic UPSQ measurements were taken at baseline and 60 days, with primary endpoint of clinical complete response (cCR) and secondary endpoints including overall survival (OS). UPSQ decreased significantly at 60 days, and low UPV risk correlated with higher cCR rates in MIBC (OR 12.5) and VHR-NMIBC (OR 3.47) subgroups, though results lost significance after multiple testing correction. The authors concluded that UPSQ may serve as a predictive biomarker for clinical outcomes in PD-1-based immunochemotherapy, with lower baseline UPSQ potentially indicating better response.
10.3389/fimmu.2026.1929760