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| Cohort P Data from the BOND-003 Study in BCG-Unresponsive Papillary Bladder Cancer |
| Mark Tyson II, MD, MPH |
| Mark Tyson speaks with Zachary Klaassen about Cohort P results from the BOND-003 trial evaluating cretostimogene grenadenorepvec in BCG-unresponsive papillary-only non-muscle-invasive bladder cancer. |
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Highlights from the 2025 Society of Urologic Oncology Annual Meeting |
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| ResQ132Ex-NMIBC: Expanded Access of Recombinant Mycobacterium BCG in NMIBC
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| Neal Shore, MD, FACS
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| The ResQ132Ex-NMIBC expanded access program provides recombinant Mycobacterium BCG to U.S. patients with non–muscle invasive bladder cancer who are eligible for BCG but unable to access it due to the ongoing national shortage or inability to join a clinical trial. This recombinant BCG, previously shown to be safe and effective in the SAKK06/14 trial, is administered according to each institution’s standard of care, with safety monitored by the sponsor.
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| ADVANCED-2: Preliminary Efficacy and Safety Data in BCG-naïve Participants with High-Grade NMIBC
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| Mark Tyson II, MD, MPH
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| The ADVANCED-2 phase II trial presented at SUO 2025 showed that TARA-002, an intravesical TLR2/NOD2 immunopotentiator, achieved a 72% high-grade complete response rate in BCG-naïve high-grade NMIBC, with durable responses through 12 months. Re-induction was notably effective, converting most initial non-responders to complete responders. TARA-002 was well tolerated with only mild, predominantly urinary, treatment-related adverse events, supporting its continued investigation as a potential bladder-sparing alternative to BCG.
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| The GAIN Trial (ALLIANCE A032303): Gemcitabine Alternating with Intravesical BCG Randomization Against BCG Alone for Patients with Recurrent “BCG Exposed” High-Grade NMIBC
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| Eugene Pietzak, MD
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| The GAIN trial is a phase III study testing whether alternating intravesical gemcitabine with BCG improves high-grade recurrence-free survival compared with BCG alone in patients with recurrent, “BCG-exposed” high-grade NMIBC—a population with limited effective options. Early phase I/II data showed remarkably high complete response rates and strong durability with gemcitabine + BCG, prompting this larger randomized evaluation.
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| Prospective Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Sustained-Release Gemcitabine Docetaxel Combination (NDV-01) in High-Risk NMIBC: Update with 9-month Complete Response Data
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| Yair Lotan, MD
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| NDV-01, a sustained-release intravesical gemcitabine/docetaxel formulation, showed strong early activity and a favorable safety profile in a prospective study of high-risk NMIBC, including BCG-naïve, BCG-exposed, and BCG-unresponsive patients. Among 29 evaluable patients, complete response rates remained high and durable—92% at any time and 85% at 9 months—with no grade ≥3 toxicities, no progressions to muscle-invasive disease, and no cystectomies reported.
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| Baseline Urinary Tumor DNA, Minimal Residual Disease and Genomic Disease Burden in Relation to Clinical Response to TAR-200 in the Phase 2b SunRISe-1 Trial
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| Girish Kulkarni, MD, PhD
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| An ad hoc analysis from the phase 2b SunRISe-1 trial showed that baseline urinary tumor DNA (utDNA) minimal residual disease status and genomic disease burden did not predict response to gemcitabine intravesical delivery (TAR-200) in BCG-unresponsive high-risk NMIBC. Patients had high complete response rates regardless of utDNA MRD positivity or negativity, with similar 1-year durability across groups.
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| Topline Results from BOND-003 Cohort P – A Multinational , Single-Arm Study of Intravesical Cretostimogene Grenadenorepvec for Treatment of High-risk, Papillary-Only, BCG-Unresponsive NMIBC
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| Mark Tyson II, MD, MPH
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| Topline results from BOND-003 Cohort P showed that intravesical cretostimogene grenadenorepvec achieved strong high-grade event-free survival in patients with high-risk, papillary-only, BCG-unresponsive NMIBC, with HG-EFS rates of ~96% at 3 months and ~85% at 6 months. No patients progressed to muscle-invasive disease or required cystectomy during follow-up, and the therapy was well tolerated with only Grade 1–2 urinary symptoms.
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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, FACS
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| Cretostimogene grenadenorepvec (CG), an oncolytic immunotherapy showing strong complete response rates and durable benefit in BCG-unresponsive NMIBC, is now available through the CRETO-EAP expanded access program for patients who lack trial access or alternative treatment options. The program features flexible eligibility criteria, locally determined assessments, and co-primary endpoints of safety and complete response, with secondary measures including duration of response, progression-free survival, and patient-reported outcomes.
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| Worldwide Clinical Practices in the Management of BCG-Unresponsive NMIBC
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| Mohamad Abou Chakra, MD
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| This global review found major variation in how clinicians manage BCG-unresponsive NMIBC, with intravesical chemotherapy commonly used in the U.S. and parts of Asia, while radical cystectomy remains the leading approach in Arab countries and some European regions. Adoption of newly FDA-approved therapies was low, underscoring a disconnect between regulatory advances and real-world practice.
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