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HIGHLIGHTS FROM THE 2023 EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY ANNUAL MEETING
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| EV-302/KEYNOTE-A39: Enfortumab Vedotin in Combination with Pembrolizumab (EV+P) Vs Chemotherapy in Previously Untreated Locally Advanced Metastatic Urothelial Carcinoma
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| Thomas Powles, MD, MBBS, MRCP
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| Thomas Powles presented the groundbreaking EV-302/KEYNOTE-A39 study results, a phase III trial comparing enfortumab vedotin plus pembrolizumab against platinum-based chemotherapy for previously untreated locally advanced/metastatic urothelial carcinoma. The EV + P combination demonstrated significant and clinically meaningful improvements, with doubled median PFS and OS, higher objective response rates, and a manageable safety profile, potentially heralding it as a new standard of care for first-line urothelial carcinoma treatment.
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| CheckMate 901: Nivolumab plus Gemcitabine-Cisplatin Versus Gemcitabine-Cisplatin Alone for Previously Untreated Unresectable or Metastatic Urothelial Carcinoma: Phase 3 Results
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| Michiel S. van der Heijden, MD, Ph.D.
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| Michiel van der Heijden presented the results of the CheckMate 901 phase III trial, which evaluated the combination of nivolumab plus gemcitabine/cisplatin versus gemcitabine/cisplatin alone in patients with previously untreated unresectable or metastatic urothelial carcinoma. The study revealed that nivolumab + gemcitabine/cisplatin significantly improved overall and progression-free survival, achieving notably higher objective response and complete response rates with deep and durable responses.
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| Discussant: EV-302/KEYNOTE-A39 & CheckMate 901: Welcoming a New Standard of Care in the First-Line Treatment of Urothelial Carcinoma
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| Andrea Apolo, MD
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| Andrea Apolo presented a discussant session at the ESMO 2023 congress on two groundbreaking studies, EV-302/KEYNOTE-A39 and CheckMate 901, which explored new standards of care in the first-line treatment of urothelial carcinoma. These trials have brought about transformative results, with enfortumab vedotin plus pembrolizumab emerging as the new standard of care for first-line treatment of unresectable or metastatic urothelial carcinoma.
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| State-Of-The-Art in Adjuvant Treatment of Renal Cell Carcinoma
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| Guillermo Antonio De Velasco Oria, MD, PhD
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| Guillermo Antonio De Velasco Oria provides an overview of the current state of adjuvant therapy for renal cell carcinoma. He discusses the historical use of tyrosine kinase inhibitors (TKIs) and the lack of curative potential in the majority of advanced RCC cases. Several adjuvant trials with TKIs had negative results, except for sunitinib in the S-TRAC trial, which showed a disease-free survival benefit but not an overall survival benefit.
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| State-of-the-Art in Adjuvant Treatment of Urothelial Cancer
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| Maria De Santis, MD
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| Maria De Santis discusses the current state of adjuvant therapy for urothelial carcinoma, emphasizing the need to improve the cure rate while minimizing life-changing side effects. Options for adjuvant therapy in urothelial carcinoma include chemotherapy, immunotherapy, and radiotherapy. Cisplatin-based chemotherapy has shown benefits in overall survival, disease-free survival, local control, and metastasis-free survival, while immunotherapy has demonstrated disease-free survival improvements in some trials. |
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| Current Peri-Operative Trial Designs and Endpoints: What Do They Mean?
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| Srikala Sridhar, MD, MSc, FRCPC
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| Srikala Sridhar's presentation highlights the state of perioperative trial designs and endpoints in genitourinary cancers. She discusses the potential use of perioperative immune checkpoint inhibitors, particularly in renal cell carcinoma, and the challenges related to their use, such as immune-mediated adverse events and the need for biomarkers to assess disease response.
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| Global Access Considerations in Systemic Treatment of Genitourinary Cancers
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| Fabio Schutz, MD
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| Fabio Schutz discusses global access considerations in the systemic treatment of genitourinary cancers during the ESMO 2023 congress. He highlights disparities in cancer incidence and mortality between developed and less developed regions, emphasizing the role of access to healthcare systems and better epidemiology statistics. Dr. Schutz also discusses the economic burden of newer drugs, especially immune checkpoint inhibitors, and how clinical trials can offer opportunities for less developed regions while stressing the importance of investment in research infrastructure in these areas.
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| 177Lu-PSMA-617 in The Pre- and Post-Taxane mCRPC Setting: Results from the Phase II IRST-185.03 Clinical Trial
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| Emilio Giunta, MD
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| Emilio Giunta presents the results of a phase II clinical trial at the 2023 ESMO annual meeting, focusing on the use of 177Lu-PSMA-617 in both the pre- and post-taxane mCRPC settings. In this open-label study, 177Lu-PSMA-617 was administered to 145 mCRPC patients. The trial found that this treatment prolonged progression-free survival and overall survival in both the pre- and post-taxane mCRPC patients.
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| Real-World Overall Survival with Enzalutamide and Abiraterone Acetate in Patients with Chemotherapy-Naïve mCRPC
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| Daniel J. George, MD
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| Daniel George discusses real-world overall survival with enzalutamide and abiraterone acetate in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). In a large, representative US Medicare dataset, patients with chemotherapy-naïve mCRPC treated with abiraterone had significantly shorter OS than those treated with enzalutamide. These results validate previous real-world studies and are robust across different healthcare systems. These findings may be particularly important in older patients and those with comorbidities.
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| Exposure-Safety Analyses of Talazoparib in Combination with Enzalutamide in Patients with mCRPC in TALAPRO-2 Trial
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| Arun A. Azad, PhD, MBBS, FRACP
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| Arun Azad discusses the exposure-safety analyses of talazoparib in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) in the TALAPRO-2 trial. This trial showed that the addition of talazoparib, a potent PARP inhibitor, to enzalutamide significantly improved radiographic progression-free survival in patients with mCRPC. These findings support the proposed dose modification algorithm as an effective approach for the management of adverse events.
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| Adjuvant Everolimus in Patients with Completely Resected Very High-Risk RCC and Clear Cell Histology: Results from the Phase III SWOG S0931 (EVEREST) Trial
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| Primo Lara, MD
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| Primo Lara presents the results of a subgroup analysis of the phase III SWOG S0931 (EVEREST) trial evaluating adjuvant everolimus in patients with completely resected very high-risk renal cell carcinoma with clear cell histology. For patients with clear cell RCC at very high-risk for recurrence, adjuvant everolimus was associated with significantly improved recurrence-free survival, compared to placebo, in a subset of patients comparable to those in S-TRAC and KEYNOTE-546.
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| A Pooled Meta-Analysis of Salvage Nivolumab/Ipilimumab after Nivolumab in Patients with Advanced Renal Cell Carcinoma
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| Rana McKay, MD
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| Rana McKay presented the results of a pooled meta-analysis focusing on the use of salvage nivolumab + ipilimumab after prior nivolumab therapy in patients with advanced renal cell carcinoma (RCC). The study found that a small subset of patients who did not respond to nivolumab monotherapy benefited from the combination of nivolumab and ipilimumab as a salvage treatment, with a 13% ORR, 6-month progression-free survival rate of 39%, and 3-year overall survival rate of 57% from nivolumab initiation.
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| CLEAR Trial, Post Hoc Analysis of the Tumor Response by Baseline Metastases in Patients with Renal Cell Carcinoma Treated with Lenvatinib + Pembrolizumab vs Sunitinib
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| Viktor Gruenwald, MD, Ph.D.
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| Dr. Viktor Gruenwald presents a post hoc analysis of the CLEAR trial, focusing on tumor response by baseline metastases in patients with renal cell carcinoma (RCC) treated with lenvatinib + pembrolizumab versus sunitinib. The analysis found that the lenvatinib + pembrolizumab combination demonstrated clinically relevant efficacy across all subgroups, including patients with different baseline metastatic characteristics.
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| STELLAR-304: A Randomized Phase 3 Study of Zanzalintinib (XL092) and Nivolumab in Non-Clear Cell Renal Cell Carcinoma
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| Sumanta Pal, MD, FASCO
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| Monty Pal presents the STELLAR-304 study, a randomized phase 3 trial that aims to assess the efficacy and safety of zanzalintinib in combination with nivolumab versus sunitinib in first-line treatment for non-clear cell RCC. Non-clear cell RCC is a heterogeneous group with distinct characteristics, and this study addresses the unmet need for effective therapies in this patient population. The primary endpoints of the trial are PFS and objective response rate, and it is currently recruiting patients in multiple countries worldwide.
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