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Session Highlights from the 2021 Annual Meeting |
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| Health-Related Quality of Life (HRQoL), Pain and Safety Outcomes in the Phase III VISION Study of 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer
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| Karim Fizazi, MD, Ph.D.
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| In this oral presentation, Dr. Karim Fizazi discussed the health-related quality of life (HRQoL) data from the VISION study of 177Lu-PSMA-617 (Lu-PSMA). The results of the VISION study, published earlier this year, demonstrated a significant improvement in rPFS and overall survival for men with mCRPC and this is the first report of the HRQoL data. |
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| Abiraterone Acetate Plus Prednisolone With or Without Enzalutamide Added to ADT Compared to ADT Alone for Men With High-Risk Non-Metastatic Prostate Cancer: Combined Analysis From Two Comparisons in the STAMPEDE Platform
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| Gerhardt Attard, MD, Ph.D., FRCP
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| In a Presidential Symposium during the ESMO Annual Congress, Gerhardt Attard presented a combined analysis from the STAMPEDE platform assessing the role of abiraterone acetate plus prednisolone with or without enzalutamide added to ADT compared to ADT alone for men with high-risk non-metastatic prostate cancer.
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| A Phase 3 Trial With a 2x2 Factorial Design in Men With De Novo Metastatic Castration-Sensitive Prostate Cancer: Overall Survival With Abiraterone Acetate Plus Prednisone in PEACE-1
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| Karim Fizazi, MD, Ph.D.
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| In a Presidential Symposium during the ESMO Annual Congress, Dr. Karim Fizazi discussed updated results of PEACE-1, a randomized Phase 3 trial in men with de novo metastatic castration-sensitive prostate cancer (mCSPC). This update focused on the overall survival (OS) for men treated with or without abiraterone plus prednisone (AAP). |
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| A Discussion on the Role of Abiraterone in Combination with Docetaxel and the Role of Abiraterone in Combination with ADT
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| Eleni Efstathiou, MD, Ph.D.
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| In this presentation, Dr. Eleni Efstathiou, discussed two Presidential Symposium presentations in prostate cancer. The first, a combined analysis from two comparisons in the STAMPEDE platform protocol presented by Gerhardt Attard. The second, overall survival with abiraterone acetate plus prednisone in PEACE-1, presented by Karim Fizazi at this year's 2021 ESMO Annual Meeting.
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| Darolutamide Maintenance in mCRPC Previously Treated with Novel Hormonal Agents and Non-Progressive Disease After Subsequent Treatment with a Taxane: A Randomized Double-Blind Placebo-Controlled Phase II Trial (SAKK 08/16)
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| Richard Cathomas, MD
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| Richard Cathomas discussed the phase II SAAK 08/16 trial assessing darolutamide maintenance in men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with novel hormonal agents and non-progressive disease after subsequent taxane therapy. The optimal treatment sequence for mCRPC remains unclear, with cross-resistance between novel hormonal agents, however with previous studies suggesting that chemotherapy may re-induce novel hormonal agent sensitivity.
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| Phase 1b/2 Study of Sabizabulin (VERU-111), an Androgen Receptor Transport Disruptor, in Men with Metastatic Castration Resistant Prostate Cancer (mCRPC) Who Failed an Androgen Receptor Targeting Agent
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| Mark Markowski, MD, Ph.D.
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| In a presentation at the ESMO Annual Congress focusing on prostate cancer, Dr. Mark Markowski presented data from a phase 1/2 trial of sabizabulin in men with metastatic castration-resistant prostate cancer (mCRPC).
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| CheckMate 9KD Cohort A2 Final Analysis: Nivolumab + Rucaparib for Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer
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| Daniel P. Petrylak, MD
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| In this presentation, Daniel Petrylak discussed results from the final analysis of CheckMate 9KD Cohort A2. This single-arm study evaluated the clinical activity of nivolumab plus rucaparib in men with metastatic castration-resistant prostate cancer (mCRPC) previously untreated with chemotherapy or a PARP inhibitor. Patients eligible for Cohort A2 were not candidates for or refused chemotherapy.
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| IMvigor011: A Global, Double-Blind, Randomized Phase 3 Study of Atezolizumab Versus Placebo As Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Post Cystectomy |
| Thomas Powles, MBBS, MRCP, MD |
| Thomas Powles discusses the IMvigor011 trial concept and design, a phase 3 trial assessing atezolizumab versus placebo as adjuvant therapy in patients with high-risk muscle-invasive bladder cancer (MIBC) who are ctDNA positive after a radical cystectomy. |
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| PD-L1 as a Predictor of Survival in Patients With Metastatic Urothelial Carcinoma From the Phase 3 DANUBE Trial of Durvalumab or Durvalumab Plus Tremelimumab Versus Standard of Care Chemotherapy
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| Joaquim Bellmunt, MD, Ph.D.
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| Joaquim Bellmunt provided an updated analysis from the DANUBE trial, evaluating PD-L1 as a predictor of survival in patients with metastatic urothelial carcinoma. The DANUBE trial was an open-label, phase III trial including patients with previously untreated mUC. The study did not meet its co-primary endpoints, however, numerically longer survival was observed in pts with high tumour PD-L1 expression who were treated with D or D+T compared with standard of care chemotherapy.
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| Erdafitinib or ERDA Plus Cetrelimab for Patients With Metastatic or Locally Advanced Urothelial Carcinoma and FGFR Alterations: First Phase 2 Results From the NORSE Study |
| Thomas Powles, MBBS, MRCP, MD
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| In this presentation, Thomas Powles presented results from the Phase 2 NORSE study of erdafitinib or erdafitinib plus cetrelimab in patients with metastatic or locally advanced urothelial carcinoma and fibroblast growth factor receptor alterations. These preliminary results discussed by Dr. Thomas Powles focused on overall response rate and safety data.
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| The Phase 2 NORSE Trial Discussion: A Novel Combination in the First-Line Setting for Patients With Metastatic or Locally Advanced Urothelial Carcinoma and FGFR Alterations |
| Srikala Sridhar, MD, MSc, FRCPC |
| Srikala Sridhar discussed the results from the Phase 2 NORSE study of erdafitinib or erdafitinib plus cetrelimab in patients with metastatic or locally advanced urothelial carcinoma (UC) and fibroblast growth factor receptor (FGFR) alterations. This study addresses a significant unmet clinical need for better first-line therapy options for patients with metastatic UC who are not eligible for cisplatin-based therapy. |
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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.
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| Sadeghi presented a phase II trial of the combination of pembrolizumab (P) and sEphB4-HSA in patients previously treated for metastatic urothelial carcinoma (mUC). This combination regime of pembrolizumab and sEphB4-HSA was well tolerated and demonstrated synergistic activity. Additionally, EphrinB2 has the potential to be a predictive biomarker of response. Based on these data, the FDA granted a breakthrough designation on September 1, 2021, for this regime in EphrinB2 positive patients. A phase III trial is in development.
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| GETUG/AFU VESPER V05 Phase III Trial of Dose Dense Methotrexate, Vinblastine, Doxorubicin and Cisplatin or Gemcitabine and Cisplatin As Perioperative Chemotherapy for Patients With MIBC |
| Christian Pfister, MD, Ph.D. |
| Christian Pfister presented the results of the GETUG/AFU VESPER V05 phase III trial assessing dose dense Methotrexate, Vinblastine, Doxorubicin and Cisplatin (dd-MVAC) compared to Gemcitabine and Cisplatin (GC) as perioperative chemotherapy for patients with muscle-invasive bladder cancer (MIBC) undergoing radical cystectomy. |
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| A Discussion on the Results of the GETUG/AFU VESPER V05 Phase III Trial and on Pembrolizumab in Combination with sEphB4-HSA in a Phase II Trial for Previously Treated Metastatic Urothelial Carcinoma
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| Enrique Grande, MD, Ph.D., MSc
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| Following presentations from Dr. Sadeghi on the role of pembrolizumab and sEphB4-HAS in patients with previously treated metastatic urothelial carcinoma and from Dr. Pfister on the role of ddMVAC as neoadjuvant chemotherapy in those with muscle-invasive disease, Dr. Enrique Grande provided an invited discussion to contextualize these papers in the Proffered Paper session of the European Society for Medical Oncology (ESMO) Annual Congress focusing on non-prostate cancer genitourinary tumors.
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