|
|
|
|
|
|
|
Highlights from the 2026 American Urologic Association (AUA) Annual Meeting
|
|
|
|
| Safety and Efficacy of Bel-sar (AU-011), a Virus-Like Drug Conjugate, in Participants with NMIBC
|
| David Cahn, MD
|
| David Cahn's AUA 2026 presentation of bel-sar (AU-011), a virus-like drug conjugate activated by near-infrared light, showed clinical complete response in 4/5 intermediate-risk and visible shrinkage in 3/5 high-risk NMIBC tumors with only grade 1 adverse events. Translational analyses demonstrated conversion of "cold" to "hot" tumors, de novo tertiary lymphoid structure formation in 3/5 patients, and immune memory generation in all evaluable participants.
|
|
|
|
|
|
| SWOG S2611 (ARCIS) a Randomized Comparison of Intravesical Therapies: A Phase III Study of Cretostimogene Grenadenorepvec/gemcitabine vs Gemcitabine/Docetaxel for the Treatment of BCG-Unresponsive and BCG-Exposed NMIBC
|
| Mark Tyson II, MD, MPH
|
| Mark Tyson's AUA 2026 presentation described SWOG S2611 (ARCIS), a randomized phase 3 trial comparing intravesical cretostimogene plus gemcitabine versus gemcitabine plus docetaxel in 308 patients with BCG-unresponsive NMIBC. The primary endpoint is event-free survival, powered to detect improvement in 2-year EFS from 40% with GEM-DOCE to 55% with CRETO-GEM, with mandatory 12-month biopsy for CIS patients and optional crossover to cretostimogene monotherapy at progression, addressing the need for prospective head-to-head evidence between these commonly utilized bladder-sparing strategies.
|
|
|
|
|
|
| ENLIGHTED Phase 3 Trial of Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy for Low-Grade UTUC
|
| Jonathan Coleman, MD
|
| Jonathan Coleman's AUA 2026 presentation of the ENLIGHTED trial evaluated padeliporfin vascular-targeted photodynamic therapy, an IV-administered photosensitizer activated by 753 nm near-infrared laser light, in 82 patients with low-grade upper tract urothelial carcinoma.
|
|
|
|
|
|
| A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with FGFR3-Altered Low-Grade, Intermediate-Risk NMIBC (SURF302)
|
| Seth Lerner, MD, FACS
|
| Seth Lerner's AUA 2026 presentation described SURF302, a phase 2 trial randomizing 60 patients with FGFR3-altered low-grade intermediate-risk NMIBC to dabogratinib 50 mg or 60 mg daily, with a primary endpoint of 3-month complete response rate. Dabogratinib is a highly selective oral FGFR3 inhibitor designed to minimize off-target toxicities, and phase 1 data showed 50% objective response in metastatic urothelial carcinoma with notably lower rates of hyperphosphatemia, stomatitis, nail disorders, and ocular toxicities compared to pan-FGFR inhibitors.
|
|
|
|
|
|
|
|
|
|
|
| MoonRISe-3: A Phase 3 Study of Erda-iDRS vs Intravesical Chemotherapy in Patients with BCG–Treated High-Risk NMIBC with Susceptible FGFR Alterations
|
| Brian Mazzarella, MD, FACS
|
| Brian Mazzarella's AUA 2026 presentation described MoonRISe-3, a phase 3 trial randomizing BCG-treated FGFR-altered papillary-only high-risk NMIBC patients 1:1 to TAR-210 versus intravesical chemotherapy, with disease-free survival as the primary endpoint. First-in-human data showed 83% 12-month recurrence-free survival with TAR-210, designed to provide sustained local erdafitinib delivery while minimizing systemic toxicities observed with oral erdafitinib, addressing an unmet need where FGFR alterations occur in ~40% of cases with 70% 5-year recurrence rates.
|
|
|
|
|
|
| Trial in Progress: REL-NDV01-301 (BOOST) - A Phase 3, Randomized Study of Adjuvant Intravesical Sustained-Release Gemcitabine-Docetaxel (NDV-01) vs Surveillance for the Treatment of Intermediate-Risk NMIBC
|
| Max Kates, MD
|
| Max Kates' AUA 2026 presentation described BOOST (REL-NDV01-301), a phase 3 randomized trial of NDV-01 versus surveillance in 276 patients with intermediate-risk NMIBC and at least one IBCG risk factor post-TURBT. The study randomizes patients to 6 biweekly NDV-01 instillations plus maintenance versus observation powered to detect improvement in 2-year disease-free survival from 60% to 75%, addressing the unmet need in intermediate-risk NMIBC where recurrence rates remain substantial despite guideline-directed TURBT and standard intravesical therapy, with primary endpoints of disease-free survival and safety, and estimated last patient enrollment in late 2027.
|
|
|
|
|
|
| A Phase 1/2 Study of Intravesical MK-3120 in Participants with Bacillus Calmette-Guérin (BCG)-Naive or BCG-Exposed High-Risk NMIBC
|
| Joshua Meeks, MD, PhD
|
| Joshua Meeks' AUA 2026 presentation described a phase 1/2 Bayesian Optimal Interval (BOIN) dose-escalation trial evaluating intravesical MK-3120, a Nectin-4-targeted antibody-drug conjugate with a topoisomerase 1 inhibitor payload, in BCG-naïve or BCG-exposed high-risk NMIBC patients with CIS ± papillary disease.
|
|
|
|
|
|
| HIVEC®-HEAT (Hyperthermic Intravesical Mitomycin [Mitomycin Medac]) for Patients with BCG-Unresponsive NMIBC Trial
|
| TR Leyshon Griffiths, BSc, MBBS, MD, FRCS Ed (Urol)
|
| TR Leyshon Griffiths' AUA 2026 presentation described HIVEC-HEAT, a UK phase 3 single-arm trial across 25 sites evaluating hyperthermic intravesical mitomycin C in BCG-unresponsive NMIBC, with Sub-Study 1 enrolling patients with CIS ± papillary Ta/T1 and Sub-Study 2 enrolling high-grade papillary Ta/T1 without CIS.
|
|
|
|
|
|
| The Phase 1/2 ResQ133A-NMIBC Trial: A Study of Intravesical Recombinant Mycobacterium BCG in BCG‑naïve Participants with NMIBC
|
| Joshua Meeks, MD, PhD
|
| Joshua Meeks' AUA 2026 presentation described ResQ133A-NMIBC, a phase 1/2 open-label multicenter trial evaluating intravesical recombinant BCG in BCG-naïve NMIBC patients, addressing the ongoing global BCG shortage. rBCG incorporates two gene modifications—urease C deletion and listeriolysin addition—designed to improve immunogenicity and safety, with prior phase 1/2 European data showing encouraging efficacy and safety in BCG-exposed recurrent NMIBC.
|
|
|
|
|
|
| MoonRISe-2, a Phase 2 Dose Expansion within the Study of Erdafitinib Intravesical Drug Releasing System (TAR-210) for Localized Bladder Cancer: Study Design and Baseline Characteristics
|
| Christopher Pieczonka, MD
|
| Christopher Pieczonka's AUA 2026 presentation described MoonRISe-2, a phase 2 study evaluating Erda-iDRS every 12 weeks for ~1 year as ablative therapy in recurrent intermediate-risk NMIBC, which has completed enrollment of 140 patients across 52 sites in 7 countries since April 2025. The study enrolled patients with recurrent low-grade Ta disease who had visible tumors ≥5 mm, at least one IBCG risk factor, and FGFR alterations, with 65.2% having 1-3 lesions and 34.8% having ≥4 lesions, representing a heavily pretreated population with median 2 prior surgeries and 41% having received prior intravesical BCG or chemotherapy.
|
|
|
|
|
|
|
|
|
|
|
