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Session Highlights from the 2021 Annual Meeting
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| Erdafitinib or Erdafitinib Plus Cetrelimab for Patients with Metastatic or Locally Advanced Urothelial Carcinoma and Fibroblast Growth Factor Receptor Alterations: First Phase 2 Results From the NORSE Study |
| Thomas Powles, MBBS, MRCP, MD |
| Thomas Powles presents the first phase 2 results from the NORSE study assessing erdafitinib or erdafitinib plus cetrelimab for patients with metastatic or locally advanced urothelial carcinoma and fibroblast growth factor receptor (FGFR) alterations. These are the first data on erdafitinib + cetrelimab in patients with newly diagnosed metastatic urothelial carcinoma with FGFR alterations who were ineligible for cisplatin-based therapy. |
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| The Phase 2 NORSE Trial Discussion: Erdafitinib or Erdafitinib Plus Cetrelimab for Patients With Metastatic or Locally Advanced Urothelial Carcinoma and FGFR Alterations
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| Srikala Sridhar, MD
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| The European Society of Medical Oncology (ESMO) 2021 meeting’s Proffered Paper Session for non-prostate genitourinary tumors included a discussant presentation by Srikala Sridhar of the phase 2 NORSE trial assessing erdafitinib or erdafitinib plus cetrelimab for patients with metastatic or locally advanced urothelial carcinoma and fibroblast growth factor receptor (FGFR) alterations.
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| Phase II Trial of Pembrolizumab in Combination with sEphB4-HSA in Previously Treated Metastatic Urothelial Carcinoma
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| Sarmad Sadeghi, MD, Ph.D., MS
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| In this presentation, Sarmad Sadeghi discussed the results of the phase 2 trial of pembrolizumab in combination with sEphB4-HSA in previously treated patients with metastatic urothelial carcinoma. The trial showed promising preliminary results for this novel systemic therapy approach.
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| Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin or Gemcitabine and Cisplatin as Perioperative Chemotherapy for Patients with MIBC: GETUG/AFU VESPER V05 Phase III Trial
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| Christian Pfister, MD, Ph.D.
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| Christian Pfister presented the results of the GETUG/AFU VESPER V05 phase III clinical trial, which compared dose-dense Methotrexate, Vinblastine, Doxorubicin and Cisplatin versus Gemcitabine and Cisplatin as perioperative chemotherapy for patients with muscle-invasive bladder cancer.
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| Results of the GETUG/AFU VESPER V05 Phase III Trial (ddMVAC vs GC in MIBC) and the Phase II Trial of Pembrolizumab plus sEphB4-HSA in Metastatic Urothelial Carcinoma |
| Enrique Grande, MD, Ph.D., MSc
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| Enrique Grande discussed the results of the GETUG/AFU VESPER V05 Phase III Trial and the Phase II trial of pembrolizumab plus sEphB4-HSA in metastatic urothelial carcinoma. These two studies led to exciting results with the potential to impact practice for patients with urothelial carcinoma in the future.
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| New Developments in Muscle-Invasive Bladder Cancer
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| Ronald de Wit, MD, Ph.D.
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| As a portion of the European Society for Medical Oncology (ESMO) Annual Congress, an Educational Session focused on improving outcomes in bladder cancer was held. In this context, Ronald de Wit discussed new developments in muscle-invasive disease.
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| How To Choose First-Line Systemic Therapy in Advanced Urothelial Cancer |
| Richard Cathomas, MD, Ph.D. |
| Richard Cathomas discussed how to select the optimal first line systemic therapy in advanced urothelial disease. Dr. Cathomas highlighted both patient- and disease-factors that may be important in choosing treatment. In terms of patient characteristics, we must consider whether a patient is platinum-eligible; if platinum eligible, whether they are cisplatin-eligible; their age; and potentially their gender. |
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| Novel Treatment Strategies in Advanced Urothelial Cancer |
| Begona Perez Valderrama, MD |
| Begona Valderrama discussed new treatments and novel approaches in advanced urothelial cancer (aUC). Dr. Valderrama highlights the current treatment landscape in aUC, emphasizing the importance of assessing whether patients are fit for cisplatin-based therapy. |
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| Analysis of Hard-to-Treat Subgroups from EV-301, a Phase 3 Trial of Enfortumab Vedotin vs Chemotherapy for Previously Treated Advanced Urothelial Carcinoma
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| Jonathan Rosenberg, MD
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| Jonathan Rosenberg presented a subgroup analysis of the EV-301 trial. This phase III trial demonstrated that treatment with enfortumab vedotin showed superior overall survival compared with standard chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma. This subgroup analysis reports on the efficacy and safety of EV for those with poor prognostic factors.
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| Atezolizumab Monotherapy in Cisplatin-Ineligible Patients with Previously Untreated Metastatic Urothelial Carcinoma: 5-Year Response and Survival Analysis from the Phase II IMvigor210 Study (Cohort 1)
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| Jonathan Rosenberg, MD
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| Jonathan Rosenberg reported long-term follow-up of the IMvigor210 Cohort 1. While cisplatin-based chemotherapy is the standard of care for first-line metastatic urothelial carcinoma, many patients are ineligible for treatment with cisplatin. Thus, Cohort 1 of the single-arm phase II IMvigor210 study evaluated the efficacy and safety of first-line atezolizumab in cisplatin-ineligible patients with mUC. These data formed the basis of the ongoing randomised phase III IMvigor130 study.
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| Treatment Patterns Among Patients With Advanced Urothelial Carcinoma in the US
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| Alicia Morgans, MD, MPH
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| Alicia Morgans presented an observational study characterizing treatment patterns and subsequent second-line therapy in both cisplatin-eligible and ineligible patients with aUC. In the past few years, programmed death 1/ligand 1 inhibitors have become recommended for first-line therapy in aUC patients who are cisplatin-ineligible and have high PD-L1 expression or who are ineligible for any platinum-containing chemotherapy regardless of PD-L1 status. However, current, real-world data on PD-1/L1i use in this setting are limited.
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| KEYNOTE-676 Cohort B: Randomized Comparator-Controlled Cohort To Evaluate Efficacy and Safety of Pembrolizumab Plus BCG in Patients With High-Risk BCG Treatment-Naive NMIBC
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| Shahrokh F. Shariat, MD
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| Shahrokh Shariat presented the KEYNOTE-676 Cohort B trial in progress. KEYNOTE-676 is an open-label, comparator-controlled, phase III study of pembrolizumab + BCG vs BCG monotherapy in patients with HR NMIBC. The initial study is enrolling patients with persistent/recurrent HR NMIBC after BCG induction while Cohort B is a new, randomized cohort that will be used to evaluate patients who are BCG treatment-naive or treatment-remote.
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| SunRISe-1: TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High Risk NMIBC Unresponsive to Intravesical BCG Who Are Ineligible for or Elected Not To Undergo Radical Cystectomy
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| Michiel Van der Heijden, MD, Ph.D.
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| Michiel Van der Heijden presented on the design of the SunRISe-1 trial. This study seems to address the paucity of treatment options for patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) unresponsive to intravesical bacillus Calmette–Guérin.
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| Tissue and Blood-Based Biomarkers for Urothelial Cancer
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| Matthew Galsky, MD
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| Matthew Galsky presented the role of tissue and blood-based biomarkers for urothelial cancer. The role of biomarkers to inform current treatment in advanced urothelial carcinoma is somewhat muddy. While PD-L1 and TMB (and ctDNA as a minimal residual disease assay) may possibly be informative and nectin-4 is not informative based on its ubiquity, only mFGFR3 is clearly useful today. The role of Trop-2 remains to be assessed.
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| Final Results on Efficacy and Patient-Reported Outcomes of a Randomized Phase II Trial Investigating Nivolumab Switch-Maintenance After TKI Induction in Metastatic Clear Cell Renal Cell Carcinoma Patients (NIVOSWITCH) |
| Christopher Darr, MD |
| Christopher Darr presented results of the phase II NIVOSWITCH trial assessing whether a 1st line switch-maintenance approach (CPI after TKI) improved outcomes in metastatic clear cell renal cell carcinoma (mRCC). Each of these treatment approaches (CP and TKI) are accepted standards of care. |
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| CABOPRE: A Phase II Study of Cabozantinib Prior to Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma
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| Guillermo De Velasco, MD, Ph.D.
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| Guillermo De Velasco discussed the CABOPRE trial, a single-arm prospective multicentre phase II trial to assess the efficacy and safety of neoadjuvant cabozantinib in patients with clear cell metastatic renal cell carcinoma and potential candidates to cytoreductive nephrectomy. Based on the data, prior to cytoreductive nephrectomy, cabozantinib at 60 mg/day is feasible and active as a perioperative treatment in intermediate/poor-risk mRCC patients.
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| To view our full coverage of the 2021 ESMO Annual Congress, visit the Conference Coverage section on UroToday.com |
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