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Highlights from the 2023 American Society of Clinical Oncology Annual Meeting
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| ENLIGHTED: A Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Padeliporfin Vascular Targeted Photodynamic Therapy in Treatment of Low-Grade UTUC |
| Evgenia Alpert, MD, Ph.D.
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| In this presentation, Evgenia Alpert discusses a phase 3 multicenter study to evaluate the safety and efficacy of padeliporfin vascular targeted photodynamic (VTP) therapy in the treatment of low-grade upper tract urothelial cancer. |
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| Age, Sex, and Race-Related Differences in Outcomes of Patients with Muscle-Invasive Bladder Cancer Treated with Radical Cystectomy: The Role of Biology Versus Access to Standard Medical Care
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| Akshay Sood, MD
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| Dr. Akshay Sood discusses disparities in outcomes among patients with muscle-invasive bladder cancer (MIBC) who undergo radical cystectomy. Bladder cancer is a complex disease that shows variations in incidence and survival based on gender, age, and race. It is uncertain whether the poorer outcomes observed in older patients, females, and African-Americans with MIBC who undergo surgery are a result of limited access to healthcare or inherent differences in tumor biology.
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| Survival Outcomes in Patients with Muscle-Invasive Bladder Cancer Receiving Neoadjuvant Chemotherapy Stratified by Number of Cycles |
| Anumita Chakraborty, MD |
| Anumita Chakraborty discusses survival outcomes in patients with muscle-invasive bladder cancer (MIBC) receiving neoadjuvant chemotherapy stratified by number of cycles. The majority of patients ended neoadjuvant chemotherapy early due to toxicity, and a significantly higher rate of patients who received <3 cycles of neoadjuvant chemotherapy experienced Grade 3 adverse events. Clinicians should prioritize administering at least 3 cycles of cisplatin-based chemotherapy when feasible to optimize outcomes, in particular RFS. |
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| Phase I/II Randomized Clinical Trial of In-Clinic Acupuncture Prior to BCG in Patients with High-Risk Non-Muscle Invasive Bladder Cancer
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| Sarah P. Psutka, MD |
| Sarah Psutka discusses the results of a phase I/II randomized clinical trial of in-clinic acupuncture prior to BCG in patients with high-risk non-muscle invasive bladder cancer (NMIBC). Acupuncture can reduce pain and urinary urgency and frequency. Treatment-related dose-limiting dysuria and irritative bladder symptoms are common in patients receiving intravesical BCG for the treatment of NMIBC. |
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| Biology and Performance of Pre- and Post-Pembrolizumab VI-RADS to Predict the Pathological Response in MIBC: Full Data Analysis from a Clinical Trials Pipeline |
| Andrea Necchi, MD |
| MRI with VI-RADS for response assessment of pembrolizumab in MIBC revealed a way for the noninvasive prediction of the pathological response and outcome, opening new avenues for a better selection of candidates to bladder-sparing strategies within clinical trials. Different VI-RADS scores not only mirrored the probability of residual MIBC after TURBT but also identified distinct biological features potentially associated with immunotherapy response. |
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| EV-103: Neoadjuvant Treatment with Enfortumab Vedotin Monotherapy in Cisplatin-Ineligible Patients with MIBC: Updated Results for Cohort H |
| Thomas W. Flaig, MD |
| Neoadjuvant enfortumab vedotin monotherapy treatment showed promising results for antitumor activity and event-free survival with a manageable safety profile in cisplatin-ineligible patients with MIBC. All patients were able to undergo surgery with no delays due to neoadjuvant enfortumab vedotin-related treatment emergent adverse events in this understudied population. These results support ongoing phase 2 and 3 programs in MIBC evaluating enfortumab vedotin alone or combined with pembrolizumab. |
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| EV-104: A First-in-Human Trial of Intravesical Enfortumab Vedotin, an Antibody-Drug Conjugate, in Patients with NMIBC: Interim Results of a Phase 1 Study |
| Morgan Roupret, Ph.D. |
| Preliminary data from EV-104 show intravesical enfortumab vedotin is well tolerated with no evidence of systemic exposure at 125mg. Preliminary antitumor activity was observed at 125mg with 3 of 4 patients achieving a complete response. Dose escalation is ongoing to identify the maximally tolerated dose or recommended dose for dose expansion. |
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| KEYNOTE-905/EV-303: A Phase 3 Study to Evaluate the Efficacy and Safety of Perioperative Pembrolizumab or Pembrolizumab + Enfortumab Vedotin for MIBC |
| Andrea Necchi, MD |
| Andrea Necchi presents KEYNOTE-905/EV-303, a phase 3 study evaluating the efficacy and safety of perioperative pembrolizumab or pembrolizumab + enfortumab vedotin for MIBC. Dr. Necchi highlights that enrollment is planned for 308 patients, and recruitment is ongoing in Africa, Asia, Australia, Europe, North America, and South America. |
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| A Phase III Randomized Trial of Eribulin with or without Gemcitabine vs Standard of Care for Metastatic Urothelial Carcinoma Refractory to or Ineligible for PD/PDL1 Antibody: SWOG S1937 |
| Sarmad Sadeghi, MD, Ph.D. |
| Sarmad Sadeghi presents the rationale and study design for SWOG S1937, a phase III randomized controlled trial of eribulin, with or without gemcitabine, versus standard of care for metastatic urothelial carcinoma refractory to or ineligible for PD-1 or PD-L1 antibodies.
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| MAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab Versus Avelumab After First-Line Platinum-Based Chemotherapy in Patients with Metastatic Urothelial Cancer |
| Shilpa Gupta, MD |
| Avelumab maintenance therapy has emerged as the current standard of care approach for metastatic urothelial carcinoma (mUC) patients without progression on first-line platinum-based chemotherapy based on results of the JAVELIN 100 trial. This trial would be the first to systematically address whether adding a multitargeted TKI, cabozantinib, to avelumab leads to an improvement in clinical outcomes compared to avelumab alone. |
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| Adding Mitomycin to BCG as Adjuvant Intravesical Therapy for High-Risk, Non–muscle-Invasive Urothelial Bladder Cancer (NMIBC): BCGMM; ANZUP 1301
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| Dickon Hayne, MD, FRCS, MBBS |
| Dickon Hayne presented the rationale/study framework and early results for ANZUP 1301, an open-label randomized phase III trial evaluating the addition of intravesical mitomycin to BCG as adjuvant intravesical therapy for high-risk, non-muscle invasive bladder cancer (NMIBC). |
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