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HIGHLIGHTS FROM THE 2024 AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING |
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| Enfortumab Vedotin with Pembrolizumab Versus Chemotherapy in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma: Analysis of Cisplatin-Eligible Population from EV-302/KEYNOTE-A39
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| Jens Bedke, MD
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| Jens Bedke presented findings from the EV-302/KEYNOTE-A39 trial, comparing enfortumab vedotin with pembrolizumab to platinum-based chemotherapy in cisplatin-eligible patients with untreated locally advanced or metastatic urothelial carcinoma. The study demonstrated that EV+P significantly improved clinical outcomes, with a median progression-free survival of 14.6 months versus 6.5 months for chemotherapy, and a median overall survival of 31.5 months versus 18.4 months for chemotherapy.
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| Secondary Analysis of the Cisplatin-Ineligible Population from EV-302/KEYNOTE-A39: Enfortumab Vedotin with Pembrolizumab Versus Chemotherapy in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma
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| Michiel Van Der Heijden, MD, Ph.D.
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| Michiel Van Der Heijden presented a secondary analysis of the cisplatin-ineligible population from the EV-302/KEYNOTE-A39 trial, comparing enfortumab vedotin with pembrolizumab versus chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma. The study showed that EV+P significantly improved progression-free survival from 6.1 to 10.6 months and overall survival compared to chemotherapy.
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| 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
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| Peter H. O'Donnell, MD
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| Peter H. O'Donnell presented updated results from the EV-103 study, focusing on neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with MIBC. The study showed promising outcomes, with a pathological complete response rate of 36.4% and a pathological downstaging rate of 50.0%. Importantly, the 2-year event-free survival rate was 62.0%, demonstrating encouraging efficacy in this population.
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| Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma (aUC): Long-Term Outcomes from JAVELIN Bladder 100 in Patients with Low Tumor Burden
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| Joaquim Bellmunt, MD, Ph.D.
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| Joaquim Bellmunt presented long-term outcomes from the JAVELIN Bladder 100 trial, focusing on patients with low tumor burden treated with avelumab first-line maintenance for advanced urothelial carcinoma (aUC). The analysis showed that avelumab plus best standard of care (BSC) significantly prolonged overall survival (OS) and progression-free survival (PFS) compared to BSC alone in patients with low tumor burden.
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| Final Results of CORE-001: A Phase-2, Single Arm Study of Cretostimogene Grenadenorepvec in Combination with Pembrolizumab in Patients with BCG-Unresponsive, Non-Muscle Invasive Bladder Cancer with Carcinoma in Situ
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| Roger Li, MD
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| Roger Li presented final results from the CORE-001 study, evaluating cretostimogene grenadenorepvec combined with pembrolizumab in BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ. The combination therapy demonstrated a 57.1% complete response rate at 12 months and 82.9% at any time, with durable responses observed up to 24 months.
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| Enfortumab Vedotin plus Pembrolizumab in the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology: A Phase II Study
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| Bassel Nazha, MD, MPH
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| Bassel Nazha presented an ongoing phase II study investigating the combination of enfortumab vedotin and pembrolizumab for treating locally advanced or metastatic bladder cancer of variant histology. Bladder cancer of variant histology is often underrepresented in clinical trials, despite expressing targets for these drugs. The trial aims to assess the objective response rate as the primary endpoint, with secondary outcomes including progression-free survival, overall survival, and safety.
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| ENLIGHTED Phase 3 Study: Efficacy and Safety of Padeliporfin Vascular Targeted Photodynamic Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer
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| Genia Alpert, MD, Ph.D.
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| Genia Alpert presented the ongoing ENLIGHTED phase 3 study, evaluating the efficacy and safety of padeliporfin vascular targeted photodynamic therapy for low-grade upper tract urothelial cancer. The study aims to demonstrate the effectiveness of padeliporfin VTP in ablating LG UTUC lesions, with preliminary data showing a high complete response rate of 77% among treated patients and manageable adverse events, consistent with prior phase 1 experience.
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| A Phase 1/2 Study of EG-70 (Detalimogene Voraplasmid) Intravesical Monotherapy for Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Carcinoma in Situ
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| Richard Bryce, MBChB, MRCGP, MFPM
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| Richard Bryce presented the ongoing LEGEND study, a phase 1/2 trial evaluating EG-70 (detalimogene voraplasmid) intravesical monotherapy for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS). EG-70 is an investigational gene-based immunotherapy that stimulates the innate and adaptive immune systems locally in the bladder.
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| Lenvatinib plus Pembrolizumab vs Sunitinib in Advanced Renal Cell Carcinoma: Patterns of Progression and Subsequent Therapy in the CLEAR Trial
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| Viktor Grünwald, MD, Ph.D.
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| Viktor Grünwald presented a follow-up analysis from the CLEAR trial, comparing lenvatinib plus pembrolizumab versus sunitinib in advanced ccRCC. The results showed that lenvatinib plus pembrolizumab significantly prolonged time to tumor progression across various organs and reduced median tumor burden at disease progression compared to sunitinib.
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| Integration of Functional Imaging in Renal Cell Carcinoma |
| Shankar Siva, Ph.D., MBBS, FRANZCR |
| Shankar Siva highlighted the evolving role of functional imaging in renal cell carcinoma (RCC), focusing on PET scanning for patients with localized and advanced disease, response assessment, and future directions. Although traditional imaging like CT or MRI remains the standard, PET imaging with tracers like 99mTechnetium-Sestamibi, 89Zr-DFO-girentuximab, and PSMA has shown promise in better characterizing RCC lesions and detecting metastases. |
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| Harnessing the Immune System in Renal Cell Carcinoma: Current and Novel Immunotherapy Approaches |
| David Braun, MD, Ph.D. |
| David Braun discussed novel immunotherapy approaches for renal cell carcinoma (RCC), emphasizing various strategies to harness the immune system against the disease. Key methods include using immune checkpoint inhibitors, cytokine therapies, vaccines, and cell therapies, as well as targeting non-T cell components like the microbiome. |
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| Association of Machine Learning–derived Histological Features with Transcriptomic Molecular Subtypes in Advanced Renal Cell Carcinoma
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| Niha Beig, MD |
| Niha Beig presented a study utilizing machine learning to derive histological features from H&E-stained slides of advanced RCC tumors, predicting transcriptomic molecular subtypes. This study identified distinct imaging-based phenotypes associated with each RCC molecular subgroup, such as angiogenic and T-effector subtypes.
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| Changes in Treatment Patterns and Attrition Rates in Patients with Metastatic Clear Cell Renal Cell Carcinoma |
| Gliceida Galarza Fortuna, MD |
| Gliceida Fortuna's analysis revealed that the approval of PD-1 inhibitor combinations for metastatic ccRCC significantly shifted first-line treatment patterns from TKI monotherapy to PD-1 combinations. Despite this shift, many patients did not receive these novel regimens, and the uptake led to more patients experiencing treatment-free intervals or being alive without further therapy one year after first-line treatment discontinuation. |
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| Comparison of TKI and CPI Strategies as First-Line Treatment of Patients with Advanced Renal Cell Carcinoma: Real-World Outcome Data from the German Research Platform CARAT
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| Peter Goebell, MD, Ph.D.
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| Peter Goebell presented a real-world analysis comparing CPIs and TKIs for first-line treatment of advanced RCC using data from the CARAT German research platform. The study, which used inverse probability of treatment weighting to emulate a randomized trial, found no statistically significant differences in progression-free survival and overall survival between CPI + TKI and CPI + CPI strategies.
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| First-Line Systemic Therapy Following Adjuvant Immunotherapy in Renal Cell Carcinoma (RCC): An International Multi-Center Study |
| Talal El Zarif, MD |
| Talal El Zarif presented an international, multi-center study on the outcomes of first-line systemic therapy following adjuvant immunotherapy in RCC patients. The study, involving 29 institutions, found that patients with recurrent RCC post-adjuvant immunotherapy benefited from subsequent systemic therapies such as VEGF inhibitors and immunotherapy combinations, with no significant differences in progression-free and overall survival among the different treatment regimens |
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| Matched Tissue and Circulating Tumor DNA (ctDNA) Analysis in Renal Cell Carcinoma (RCC): Results from a Multimodal Real-World Database |
| Rana McKay, MD |
| Rana McKay presented a study analyzing matched tissue and circulating tumor DNA (ctDNA) in renal cell carcinoma (RCC) patients using the Tempus multimodal database. The study found that ctDNA profiling complements tissue-based next-generation sequencing (NGS) by increasing the detection of genomic alterations, particularly in metastatic cases. |
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