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HIGHLIGHTS FROM THE 2024 EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY ANNUAL MEETING |
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AMBASSADOR Trial: Extended Follow-up on Adjuvant Pembrolizumab in Bladder Cancer
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Andrea Apolo, MD
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| Andrea Apolo discusses extended follow-up data from the AMBASSADOR trial. This phase 3 study evaluates adjuvant pembrolizumab versus observation in high-risk muscle-invasive urothelial carcinoma. With 45-month follow-up, pembrolizumab demonstrates significant improvement in disease-free survival.
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| Disitamab Vedotin: Promising HER2-Targeted Therapy for Urothelial Cancer |
| Mathew Galsky, MD |
| Matthew Galsky discusses preliminary results from the RC48G001 Study Cohort C, evaluating disitamab vedotin plus pembrolizumab in HER2-expressing metastatic urothelial cancer. The study shows a 75% response rate in treatment-naive patients, with activity observed in both HER2-positive and HER2-low tumors. |
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Presidential Symposium II: Practice-Changing Trials
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| Randomized Phase 3 Trial of Neoadjuvant Durvalumab plus Chemotherapy Followed by Radical Cystectomy and Adjuvant Durvalumab in Muscle-Invasive Bladder Cancer (NIAGARA)
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| Thomas B. Powles, MBBS, MRCP, MD
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| Thomas B. Powles presented the NIAGARA trial, a phase 3 study evaluating neoadjuvant Durvalumab plus chemotherapy followed by radical cystectomy and adjuvant Durvalumab in muscle-invasive bladder cancer. The trial demonstrated that the addition of Durvalumab significantly improved event-free survival and overall survival compared to chemotherapy alone, with EFS at 2 years being 67.8% vs. 59.8% and an OS hazard ratio of 0.75.
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Mini Oral Session: GU Tumours, Non-Prostate
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| TAR-200 +/- Cetrelimab and Cetrelimab Alone in Patients with BCG-Unresponsive High-Risk NMIBC: Updated Results from SunRISe-1 |
| Michiel Van der Heijden, MD, PhD
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| Michiel Van der Heijden presented updated results from the SunRISe-1 trial assessing TAR-200 ± cetrelimab and cetrelimab alone in BCG-unresponsive high-risk NMIBC. TAR-200 monotherapy achieved the highest complete response rate and demonstrated durable responses with 82% of patients remaining in response after 9.2 months. TAR-200 was well-tolerated with fewer severe adverse events compared to the combination with cetrelimab, supporting its further development as a monotherapy for these patients.
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| Alliance A031501: AMBASSADOR Study of Adjuvant Pembrolizumab in Muscle-Invasive Urothelial Carcinoma vs Observation: Extended Follow-up DFS Results and Metastatic Disease Recurrence Distribution |
| Andrea Apolo, MD |
| Andrea Apolo reports that the AMBASSADOR study demonstrated that adjuvant Pembrolizumab significantly improves disease-free survival compared to observation in high-risk muscle-invasive urothelial carcinoma, with a hazard ratio of 0.73. The benefit was consistent across subgroups, and common metastatic sites included lymph nodes, lung, bone, and liver, supporting Pembrolizumab as a viable adjuvant therapy. |
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| ctDNA Clearance with Neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin for Cisplatin-Ineligible MIBC from the Safety Run-in Cohort of the Phase 3 VOLGA Trial |
| Alexandra Drakaki, MD |
| Alexandra Drakaki presents findings from the safety run-in cohort of the VOLGA trial, which investigated neoadjuvant durvalumab, tremelimumab, and enfortumab vedotin in cisplatin-ineligible muscle-invasive bladder cancer. The exploratory analysis showed that ctDNA clearance during treatment was associated with favorable pathologic responses and longer event-free survival. |
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| Invited Discussant: Improving Outcomes of Localized Urothelial Cancer |
| Maria De Santis, MD, PhD |
| Maria De Santis reviews three key abstracts on urothelial carcinoma. She highlighted that TAR-200 monotherapy showed high complete response rates in BCG-unresponsive NMIBC, though long-term durability needs further confirmation. The AMBASSADOR study demonstrated pembrolizumab's significant benefit in disease-free survival for muscle-invasive urothelial carcinoma, with overall survival data still pending. |
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| Anlotinib Combined with Anti-PD-L1 Antibody Benmelstobart (TQB2450) Versus Sunitinib in First-Line Treatment of Advanced Renal Cell Carcinoma -a Randomized, Open-Label, Phase III Study (ETER100)
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| Xinan Sheng, MD
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| Xinan Sheng presentes results from the ETER100 phase III trial comparing Anlotinib plus the anti-PD-L1 antibody Benmelstobart to sunitinib for first-line treatment of advanced renal cell carcinoma. The combination of Benmelstobart and Anlotinib significantly improved progression-free survival and overall response rate compared to sunitinib.
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| Fecal Microbiota Transplantation (FMT) Versus Placebo in Patients Receiving Pembrolizumab plus Axitinib for Metastatic Renal Cell Carcinoma. Preliminary Results of the Randomized Phase 2 TACITO Trial |
| Chiara Ciccarese, MD
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| Chiara Ciccarese presents the preliminary results from the TACITO trial, which evaluated fecal microbiota transplantation versus placebo in patients with metastatic renal cell carcinoma receiving pembrolizumab plus axitinib. The trial found that FMT significantly improved the 1-year progression-free survival rate and overall response rate. |
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| Novel Serum Glycoproteomic Biomarkers Predict Response to Nivolumab plus Cabozantinib Versus Sunitinib in Advanced RCC: Analysis from CheckMate 9ER
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| David Braun, MD, PhD
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| David A. Braun presented an analysis from the CheckMate 9ER trial exploring novel serum glycoproteomic biomarkers to predict responses to Nivolumab plus Cabozantinib versus Sunitinib in advanced renal cell carcinoma. The study identified 24 glycopeptides associated with progression-free survival and overall survival in the Nivolumab + Cabozantinib group, noting that higher levels of sialylated and fucosylated glycoproteins correlated with worse outcomes.
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| Discussion: Phase II TACITO Trial, Phase III Study (ETER100), and Novel Serum Glycoproteomic Biomarkers Predict Response to Nivolumab Plus Cabozantinib vs Sunitinib in Advanced Renal Cell Carcinoma |
| Camillo Guglielmo Porta, MD
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| Camillo Porta reviews three studies on advanced RCC: The ETER100 trial found that Anlotinib plus Benmelstobart significantly improved progression-free survival compared to Sunitinib, though overall response rates were low. The TACITO trial showed that fecal microbiota transplantation enhanced progression-free survival and response rates when combined with Pembrolizumab plus Axitinib, but its practical application is challenging.
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| Phase 2 Study of Futibatinib plus Pembrolizumab in Patients with Advanced/Metastatic Urothelial Carcinoma: Final Analysis of Efficacy and Safety
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| Vadim Koshkin, MD
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| The phase 2 study of futibatinib plus pembrolizumab in advanced/metastatic urothelial carcinoma showed promising efficacy, particularly in patients with FGFR3 mutations or FGFR1-4 fusions/rearrangements. The confirmed overall response rate in this group was 47.1%, with a median progression-free survival of 8.3 months and a median duration of response of 12.3 months. |
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| EV-302: Exploratory Analysis of Nectin-4 Expression and Response to 1L Enfortumab Vedotin + Pembrolizumab in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
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| Thomas Powles, MBBS, MRCP, MD
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| Tom Powles presented an exploratory analysis from the EV-302 study, which evaluated Nectin-4 expression in patients with locally advanced or metastatic urothelial carcinoma receiving first-line Enfortumab Vedotin plus Pembrolizumab. The analysis showed that Nectin-4 expression was high across most patients, and the combination treatment provided consistent benefits in progression-free survival , overall survival, and overall response rate regardless of Nectin-4 or PD-L1 status.
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| Invited Discussant: Phase 2 Study of Futibatinib Plus Pembrolizumab, EV-302 Exploratory Analysis, and Preliminary Efficacy of Disitamab Vedotin with Pembrolizumab in Advanced Urothelial Carcinoma |
| Aristotelis Bamias, MD
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| Aristotelis Bamias discussed three key presentations on treatment options for metastatic urothelial carcinoma. He highlighted the efficacy of futibatinib plus pembrolizumab in patients with FGFR alterations, showing promise for FGFR-targeted strategies. He also reviewed the EV-302 trial, which demonstrated consistent benefits of Enfortumab Vedotin plus Pembrolizumab across Nectin-4 expression subgroups, confirming the combination as a standard of care without needing Nectin-4 or PD-L1 testing.
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