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Highlights from the 2026 ASCO Genitourinary Cancers Symposium
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| Updated Clinical Results and Associated Biomarkers from an Ongoing Phase 1 Study of FX-909, a First-in-Class Peroxisome Proliferator-Activated Receptor Gamma (PPARG) Inhibitor, in Patients with Advanced Urothelial Carcinoma
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| Matthew Galsky, MD
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| Updated phase 1 data for FX-909, a first-in-class oral PPARG inhibitor, show manageable safety and promising antitumor activity in heavily pretreated advanced urothelial carcinoma, particularly in tumors with high PPARG expression, where most patients had tumor shrinkage and several partial responses. Strong concordance between PPARG IHC and mRNA, along with ctDNA reductions in responders, supports PPARG-high status as an emerging companion biomarker, and has led to an ongoing part B expansion randomizing 30 mg vs 50 mg FX‑909 in biomarker-selected patients.
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| SWOG S1602: A Phase III Randomized Trial to Evaluate BCG Strain Differences and Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naïve High-Grade Nonmuscle-Invasive Bladder Cancer
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| Robert Svatek, MD
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| SWOG S1602 showed that Tokyo BCG is non-inferior to TICE BCG for high‑grade recurrence‑free survival in BCG‑naïve high‑grade NMIBC, supporting Tokyo as a viable alternative during BCG shortages. Priming with intradermal BCG did not improve outcomes or meaningfully alter PPD conversion, which occurred in only about 30% of patients and was not associated with better high‑grade recurrence‑free survival.
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| Design and Implementation of a Patient-Centric Expanded Access Program with Cretostimogene Grenadenorepvec in NMIBC Unresponsive to BCG
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| Sarah Psutka, MD, MS
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| This trials-in-progress presentation described CRETO-EAP, an expanded access program offering intravesical cretostimogene grenadenorepvec to real-world patients with high-risk BCG-unresponsive NMIBC who are unfit or unwilling to undergo cystectomy, using broad, pragmatic eligibility.
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| Response to Primary Chemoablation with UGN-102 in Different EORTC Risk Groups
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| William Huang, MD
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| William Huang’s post-hoc ENVISION analysis showed that primary chemoablation with UGN-102 achieved high 3‑month complete response rates across EORTC recurrence score groups—83.9%, 81.2%, and 60% —with roughly two-thirds to three-quarters of responders remaining event-free at 24 months. These results suggest UGN‑102 provides durable, clinically meaningful disease control even in patients with higher baseline recurrence risk within recurrent low‑grade, intermediate‑risk NMIBC.
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| Treatment of Recurrent NMIBC with UGN-301 (Zalifrelimab) Alone and in Combination: A Phase 1 Dose Escalation Study
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| Karim Chamie, MD, MSHS
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| This phase 1 dose-escalation study showed that intravesical UGN-301 (zalifrelimab), given alone or with UGN-201 or gemcitabine, was well tolerated in recurrent NMIBC, with no dose-limiting toxicities and minimal systemic CTLA‑4 exposure. Early efficacy signals were encouraging, including meaningful complete response rates in CIS and favorable 12‑week recurrence-free rates in Ta/T1 disease, leading to selection of 500 mg UGN‑301 as the recommended phase 2 dose.
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| Topline Results from BOND-003 Cohort P: A Multi-National, Single-Arm Study of Intravesical Cretostimogene Grenadenorepvec for Treatment of High-Risk, Papillary Only, BCG-Unresponsive NMIBC
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| Sia Daneshmand, MD
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| Topline data from BOND-003 Cohort P show that intravesical cretostimogene grenadenorepvec achieved high-grade event-free survival rates of 95.7%, 84.6%, and 80.4% at 3, 6, and 9 months, respectively, in high-risk papillary-only BCG-unresponsive NMIBC, with consistent control in both HG Ta and HG T1 disease. No patients required cystectomy or progressed to muscle-invasive disease, and treatment was well tolerated with mostly low-grade local bladder symptoms, supporting cretostimogene as a promising bladder-sparing option for this difficult-to-treat population.
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| First Results from CORE-008 Cohort A: Phase 2 Study of Intravesical Cretostimogene Grenadenorepvec in Patients with HR BCG-Naïve NMIBC
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| Gary Steinberg, MD
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| CORE-008 cohort A showed that intravesical cretostimogene grenadenorepvec produced an 83.7% complete response rate at any time in high-risk BCG-naïve NMIBC with CIS, with consistent activity across CIS-alone, CIS+Ta, and CIS+T1 subgroups and no progression to muscle-invasive or metastatic disease at early follow-up. Treatment was very well tolerated, with mostly low-grade, bladder-localized adverse events, no serious treatment-related events, and nearly all patients completing planned induction and early maintenance, supporting further development of cretostimogene in earlier high-risk NMIBC settings.
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| Efficacy and Safety of Disitamab Vedotin Combined with Intravesical Electromotive Mitomycin-C in Patients with HER-2 Expressing High-Risk NMIBC: A Phase II Study
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| Xuebing Han
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| This phase II single-arm trial is testing systemic disitamab vedotin (RC48-ADC) combined with intravesical electromotive mitomycin C in patients with HER2-expressing high-risk NMIBC after complete TURBT. Early results in 18 patients show promising disease control with only grade 1–2 treatment-related adverse events—mainly mild neuropathy and alopecia—and no grade ≥3 toxicities, suggesting a well-tolerated, biologically targeted alternative to BCG for this population.
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| Neoadjuvant Sacituzumab Govitecan + Pembro, Followed by Response-Adapted Bladder Sparing and Adjuvant Pembro, in Patients with MIBC: SURE-02 Primary Analysis and Biomarker Results
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| Andrea Necchi, MD
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| SURE-02 showed that neoadjuvant sacituzumab govitecan plus pembrolizumab achieved a 38.8% clinical complete response rate in cisplatin-ineligible or -refusing MIBC, allowing about 40% of patients to pursue a bladder-sparing strategy with 12‑month event-free survival of 90.9% in cCR patients. The regimen had manageable toxicity, and biomarker analyses suggested higher response rates in luminal tumors—especially those with ERBB2 alterations and enriched mismatch repair signatures—supporting further study of response-adapted bladder preservation using ADC + ICI combinations.
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