| ESMO 2024 Scientific Congress Highlights: Genitourinary Tumors, Kidney and Bladder Cancer |
| Ignacio Duran, MD, PhD
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| At ESMO 2024, Dr. Ignacio Duran presented key insights into the management of kidney and bladder cancers, focusing on clinical trials in mRCC and muscle-invasive bladder cancer. His highlights included the potential role of sequencing immunotherapy, perioperative strategies, and novel approaches such as TAR-200 and ctDNA testing. |
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HIGHLIGHTS FROM THE 2024 EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY ANNUAL MEETING |
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TiNivo-2 Trial Results: Tivozanib in Advanced Renal Cell Carcinoma Treatment
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Toni Choueiri, MD
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| Toni Choueiri discusses the TiNivo-2 trial results, comparing tivozanib-nivolumab combination to tivozanib monotherapy in advanced clear cell renal cell carcinoma. The study, involving 343 patients, shows no benefit in rechallenging with nivolumab after prior immunotherapy.
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| Tivozanib–Nivolumab vs Tivozanib Monotherapy in Patients with RCC Following 1 or 2 Prior Therapies including an Immune Checkpoint Inhibitor – Results of the Phase III TiNivo-2 Study
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| Toni Choueiri, MD
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| Toni Choueiri presented the TiNivo-2 trial results, comparing tivozanib plus nivolumab to tivozanib monotherapy in RCC patients who had progressed after 1-2 prior therapies, including immune checkpoint inhibitors. The study found no significant improvement in progression-free survival with the tivozanib and nivolumab combination versus tivozanib alone, and overall survival was similar between the two groups.
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| Prospective Randomized Phase II Trial of Ipilimumab + Nivolumab Versus Standard of Care in Non-Clear Cell RCC: Results of the SUNNIFORECAST Trial |
| Lothar Bergmann, MD |
| Lothar Bergmann presented the SUNNIFORECAST trial, a Phase II study comparing ipilimumab + nivolumab to standard care in treatment-naïve patients with advanced non-clear cell RCC. The trial demonstrated that ipilimumab + nivolumab significantly improved 12-month overall survival and had a higher objective response rate compared to standard care. |
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| Final Analysis of the Phase 3 LITESPARK-005 Study of Belzutifan Versus Everolimus in Participants with Previously Treated Advanced Clear Cell RCC |
| Brian I. Rini, MD, FASCO |
| Brian Rini presented the final analysis of the Phase 3 LITESPARK-005 study comparing belzutifan to everolimus in previously treated advanced clear cell RCC. Belzutifan demonstrated significant benefits in progression-free survival and objective response rate, with a median progression-free survival of 5.6 months compared to 5.6 months for everolimus, and an objective response rate of 22.7% versus 3.5%. |
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| Fecal Microbiota Transplantation vs Placebo in Patients Receiving Pembrolizumab plus Axitinib for Metastatic Renal Cell Carcinoma. Preliminary Results of the Randomized Phase 2 TACITO Trial |
| Chiara Ciccarese, MD |
| Chiara Ciccarese presented preliminary results from the Phase 2 TACITO trial, which evaluated the impact of fecal microbiota transplantation versus placebo in patients with mRCC receiving pembrolizumab plus axitinib. The trial found that FMT significantly improved progression-free survival and overall response rate compared to placebo, with a median progression-free survival of 14.2 months versus 9.2 months. |
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| Novel Serum Glycoproteomic Biomarkers Predict Response to Nivolumab plus Cabozantinib Versus Sunitinib in Advanced RCC: Analysis from CheckMate 9ER |
| David A. Braun, MD, PhD
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| David Braun presents findings from the CheckMate 9ER trial, showing that higher levels of sialylated and fucosylated serum glycopeptides are linked to poorer outcomes with both nivolumab plus cabozantinib and sunitinib in advanced RCC. Additionally, high serum levels of complement protein 3 and low levels of complement factor H glycopeptides may predict a better response to nivolumab plus cabozantinib compared to sunitinib.
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SunRISe-4 Trial Explores TAR-200 and Cetrelimab Combination for Bladder Cancer Treatment
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Andrea Necchi, MD
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| Andrea Necchi discusses the SunRISe-4 trial results, evaluating TAR-200 combined with cetrelimab in cisplatin-ineligible muscle-invasive bladder cancer patients. The study shows promising efficacy with a 42% pathological complete response rate for the combination therapy, compared to 23% for cetrelimab alone
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| TAR-200 plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Patients with Muscle-Invasive Bladder Cancer Who Are Ineligible for or Refuse Neoadjuvant Cisplatin-Based Chemotherapy: Interim Analysis of SunRISe-4 |
| Andrea Necchi, MD |
| Andrea Necchi presents interim results from the SunRISe-4 trial, which evaluated TAR-200 plus cetrelimab versus cetrelimab alone as neoadjuvant therapy in patients with MIBC ineligible for or refusing cisplatin-based chemotherapy. The combination of TAR-200 and cetrelimab achieved a pathologic complete response rate of 42% and a pathologic objective response rate of 60%, compared to 23% and 36% for cetrelimab monotherapy, respectively. |
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| Identification of Bladder Cancer Patients That Could Benefit from Early Post-Cystectomy Immunotherapy Based on Serial Circulating Tumour DNA Testing: Preliminary Results from the TOMBOLA Trial
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| Jørgen Bjerggaard Jensen, MD
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| Jørgen Bjerggaard Jensen presents preliminary findings from the TOMBOLA trial, demonstrating that serial circulating tumor DNA (ctDNA) testing after radical cystectomy can help identify bladder cancer patients who might benefit from early post-surgery immunotherapy. The study found that 56% of patients were ctDNA positive post-surgery, and 55% of these patients converted to ctDNA negative following treatment with atezolizumab.
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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 Powles, MBBS, MRCP, MD
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| The NIAGARA trial was presented as the first Phase 3 study assessing perioperative Durvalumab with chemotherapy in muscle-invasive bladder cancer (MIBC). This trial demonstrated that adding Durvalumab to neoadjuvant chemotherapy significantly improved event-free survival and overall survival compared to chemotherapy alone.
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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 S. Koshkin, MD
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| Vadim S. Koshkin presents the final analysis of a Phase 2 study evaluating futibatinib plus pembrolizumab in patients with advanced or metastatic urothelial carcinoma. This study aimed to determine the efficacy and safety of this combination in patients who are ineligible for or have declined platinum-based chemotherapy.
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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 |
| Thomas Powles, MBBS, MRCP, MD
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| Thomas Powles presents an exploratory analysis from the Phase 3 EV-302 study, examining the relationship between Nectin-4 expression and response to first-line enfortumab vedotin plus pembrolizumab in patients with advanced urothelial cancer. The analysis showed that high Nectin-4 expression did not significantly impact the efficacy of EV plus pembrolizumab, as the combination demonstrated consistent benefits in progression-free survival and overall survival across all Nectin-4 expression levels. |
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