|
|
|
|
|
|
|
PEER-TO-PEER CLINICAL CONVERSATIONS |
|
|
|
|
|
| QUILT-2.005: Comparing BCG + IL-15 Superagonist N-803 vs BCG Alone in BCG-Naïve NMIBC |
| Sandeep (Bobby) Reddy, MD |
| Sam Chang speaks with Sandeep (Bobby) Reddy about the FDA-approved agent Anktiva combined with BCG for BCG-unresponsive non-muscle invasive bladder cancer. Dr. Reddy discusses the results from the QUILT 2.005 trial, showing high durability and response rates in patients. |
|
|
|
|
|
|
|
|
|
|
|
| LEGEND Trial Investigates EG-70 in Bladder Cancer Patients |
| Gautier Marcq, MD, MSc |
| Zachary Klaassen interviews Gautier Marcq about the LEGEND trial, a phase 1/2 study of detalimogene voraplasmid (EG-70) for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. Dr. Marcq discusses the trial design, which involves intravesical administration of EG-70, a non-viral gene medicine-based immunotherapy. |
|
|
|
|
|
|
|
|
|
|
|
| Enfortumab Vedotin and Stereotactic Radiation Tested Before Surgery in Muscle-Invasive Bladder Cancer in STAR-EV Trial |
| Tian Zhang, MD, MHS |
| Leslie Ballas and Tian Zhang discuss the STAR-EV trial, a new study combining enfortumab vedotin (EV) and radiation for muscle-invasive bladder cancer patients ineligible for cisplatin. Dr. Zhang outlines the trial's design, which uses three EV cycles followed by targeted radiation and cystectomy. |
|
|
|
|
|
|
|
|
|
|
|
| Pembrolizumab + Chemoradiation vs. Trimodality Therapy for Muscle-Invasive Bladder Cancer: The KEYNOTE-992 Trial |
| Neal Shore, MD, FACS |
| Sam Chang interviews Neal Shore about the KEYNOTE-992 trial comparing immunotherapy combined with chemoradiation to standard trimodality therapy for muscle-invasive bladder cancer. Dr. Shore explains that the trial evaluates Pembrolizumab with chemoradiation versus placebo with chemoradiation in patients suitable for bladder-sparing approaches. |
|
|
|
|
|
|
|
|
|
|
|
| The Role of Urologist in Bladder Preservation Strategies |
| James Catto, Ph.D. |
| James Catto discusses the urologist's role in bladder preservation strategies using "The 5 S’s": Selection of candidates, Staging for neoadjuvant therapy response, Surveillance for recurrence, Salvage if needed, and Support. Emphasizing maximal TURBT and surveillance with MRI and ctDNA, he highlights these strategies' effectiveness and the importance of collaboration with oncology teams to improve bladder preservation outcomes in eligible patients. |
|
|
|
|
|
| First Safety and Efficacy Results of the TAR-210 Erdafitinib Intravesical Delivery System in Patients with Non–muscle-Invasive Bladder Cancer with Select FGFR Alterations |
| Antoni Vilaseca, MD, FEBU |
| Antoni Vilaseca presents promising first results for the TAR-210 erdafitinib intravesical delivery system in patients with NMIBC with FGFR alterations. In a phase 1 study, TAR-210 achieved a 12-month recurrence-free survival rate of 90% in high-risk NMIBC patients and a 90% complete response rate at 12 weeks in intermediate-risk patients, with sustained erdafitinib release in the bladder over 90 days and minimal systemic exposure. Adverse events were generally mild, supporting the progression of TAR-210 to further clinical trials. |
|
|
|
|
|
|
|
|
|
|
| TAR-200 in Patients with BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results from the SunRISe-1 Study |
| Joseph Jacob, MD, MCR |
| Joseph Jacob presents encouraging results from the phase 2b SunRISe-1 study, which investigated TAR-200, a gemcitabine-releasing system, in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer. TAR-200 showed a high complete response rate, with 82.8% by central review and 86.2% by investigator assessment, and durable responses—estimated 12-month duration of response was 74.6%. Adverse events were generally mild, with few patients discontinuing treatment due to side effects. |
|
|
|
|
|
| Bladder Preservation - A Modern Choice for Patients
|
| Leslie Ballas, MD, FASTRO
|
| Leslie Ballas led a session on bladder preservation for muscle-invasive bladder cancer (MIBC), emphasizing trimodality therapy (TMT) as a viable alternative to radical cystectomy for appropriately selected patients. TMT, which combines maximal transurethral resection of the bladder tumor (mTURBT), chemoradiotherapy, and selective salvage cystectomy, has shown comparable oncologic outcomes to cystectomy in terms of disease-free and overall survival, as evidenced by trials like RTOG 05-24 and BC2001.
|
|
|
|
|
|
| Perioperative Sacituzumab Govitecan Alone or in Combination with Pembrolizumab for Patients with Muscle-Invasive Urothelial Bladder Cancer: SURE-01/02 Interim Results |
| Antonio Cigliola, MD |
| Interim results from the SURE-01/02 trial highlight promising efficacy and manageable safety concerns of perioperative sacituzumab govitecan (SG) for MIBC, especially in cisplatin-ineligible patients. In SURE-01, 36.4% of patients achieved a pathologic complete response post-cystectomy, with a modified dose and prophylactic measures reducing severe adverse events like neutropenia and diarrhea. Additionally, some patients achieving a clinical complete response were able to pursue bladder-preserving treatments, showing potential for individualized therapeutic approaches. |
|
|
|
|
|
| Study EV-103: Neoadjuvant Treatment with Enfortumab Vedotin Monotherapy in Cisplatin-Ineligible Patients with Muscle Invasive Bladder Cancer (MIBC) 2-Year Event-Free Survival and Safety Data for Cohort H |
| Peter H. O'Donnell, MD |
| In the EV-103 study, neoadjuvant enfortumab vedotin monotherapy showed promising results for cisplatin-ineligible muscle-invasive bladder cancer patients, achieving a 2-year event-free survival rate of 62% and a 36.4% pathological complete response rate. Most patients tolerated the treatment well, with manageable adverse events, and all completed surgery without delays from treatment-related issues. |
|
|
|
|
|
| Activity of Enfortumab Vedotin and Sacituzumab Govitecan with Radiation in Preclinical Models of Bladder Cancer - Beyond the Abstract |
| Vincent D’Andrea, MD, Yuzhen Zhou, Kent Mouw, MD, PhD |
| This preclinical study explored the effects of combining enfortumab vedotin (EV) and sacituzumab govitecan (SG), two antibody-drug conjugates, with radiation therapy (RT) in bladder cancer models. Results showed additive cytotoxicity between RT and each drug in cell lines, with some models exhibiting synergy. In vivo, the combination of EV or SG with RT significantly reduced tumor size and weight and enhanced DNA damage and apoptosis. |
|
|
|
|
|
|
|
|
|
|
