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HIGHLIGHTS FROM THE 2023 EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY ANNUAL MEETING
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PSMAfore Study Unveils Game-Changing Results for Prostate Cancer Treatment
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A. Oliver Sartor, MD
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| Oliver Sartor joins Alicia Morgans to discuss the eagerly anticipated results from the PSMAfore study (NCT04689828), a phase three trial exploring PSMA-617 lutetium for taxane-naive patients with metastatic castrate-resistant prostate cancer (mCRPC). Notable findings from the study revealed significantly improved radiographic progression-free survival (rPFS) with PSMA-617 lutetium vs a change in ARPI.
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| PSMAfore Phase 3 Trial of [177Lu]Lu-PSMA-617 in Taxane-Naive Patients with Metastatic Castration-Resistant Prostate Cancer
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| Oliver Sartor, MD
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| Oliver Sartor presented the results of the PSMAfore phase 3 trial, which investigated 177Lu-PSMA-617 in taxane-naive patients with mCRPC. The study found that 177Lu-PSMA-617 significantly prolonged rPFS compared to a change in androgen receptor pathway inhibitors. Secondary and exploratory endpoints, including PSA response, objective response rate, and quality of life measures, also favored 177Lu-PSMA-617, and it demonstrated a manageable safety profile.
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| PSMAfore Discussant: Using Clinical Intelligence to Define First Line mCRPC Therapy |
| Christopher Sweeney, MBBS
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| Christopher Sweeney discussed the PSMAfore phase 3 trial, highlighting its strengths such as being a well-powered randomized controlled trial that documented various aspects of activity in patients with mCRPC. Dr. Sweeney emphasized the need for personalized treatment principles in mCRPC, with the first principle being that all patients with mHSPC should be offered the most effective hormonal therapy available, and the second principle involving precision medicine for first-line mCRPC therapy based on individual patient profiles and tumor characteristics.
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| ARASTEP: Darolutamide + ADT in Patients with High-Risk BCR Prostate Cancer – A Phase 3 Study
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| Alicia Morgans, MD, MPH
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| Alicia Morgans presented the ARASTEP study, a phase 3, randomized, double-blind, placebo-controlled trial that assesses darolutamide in combination with androgen deprivation therapy in patients with high-risk biochemical recurrence of prostate cancer. The study aims to determine whether darolutamide, an androgen receptor inhibitor, improves radiological rPFS by PSMA PET/CT compared to a placebo in patients with BCR following primary therapy and PSMA PET/CT-positive lesions.
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| Phase 1/2 Trial of Oral EPI-7386 in Combination with Enzalutamide Compared to Enzalutamide Alone in mCRPC Subjects: Current Phase 1 results
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| Andrew L. Laccetti, MD, MS
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| Andrew Laccetti presents the results of a phase 1/2 trial of oral EPI-7386 in combination with enzalutamide versus enzalutamide alone in patients with metastatic castration-resistant prostate cancer. EPI-7386, a next-generation antiandrogen, was tested in combination with enzalutamide, showing good tolerability and significant reductions in PSA levels, with rapid and deep PSA declines observed in patients regardless of previous chemotherapy status.
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| Effect of Rapid Ultra-Low Prostate-Specific Antigen Decline (UL PSA) in TITAN Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Who Received Apalutamide plus Androgen Deprivation Therapy
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| Axel Merseburger, MD, Ph.D.
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| The secondary analysis of the TITAN trial investigated the influence of rapid ultra-low PSA (Prostate-Specific Antigen) declines in metastatic castration-sensitive prostate cancer (mCSPC) patients treated with apalutamide. This analysis found that achieving significant PSA reductions was associated with improved clinical outcomes, underlining the potential therapeutic advantages of this approach in mCSPC management.
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| Association of Health-Related Quality of Life with Efficacy Outcomes in the VISION Study of Patients with mCRPC
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| Michael Morris, MD |
| Michael Morris discussed the association of health-related quality of life with efficacy outcomes in the VISION study of patients with metastatic castration-resistant prostate cancer. The phase 3 VISION trial demonstrated that 177Lu-PSMA-617 and protocol-permitted standard of care in patients with PSMA-positive mCRPC significantly prolonged radiographic progression-free survival and overall survival relative to standard of care alone.
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| First Real-Life Data on 177Lu-PSMA-617: Descriptive Analysis on the Largest Metastatic Castration-Resistant Prostate Cancer Cohort Treated in Early Access in France
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| Anne-Laure Giraudet, MD
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| Anne-Laure Giraudet presents descriptive results of the first real-life data on 177Lu-PSMA-617 from the early access program in France, which included patients with metastatic castration-resistant prostate cancer. These patients, who were heavily pretreated, showed poorer performance status and a higher prevalence of lymph node metastases compared to those in the VISION trial. |
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| Combination Treatment with Radium-223 and Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer in the REASSURE Study
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| Bertrand Tombal, MD, Ph.D.
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| Bertrand Tombal presents the findings from the REASSURE study, which explored the combination treatment of radium-223 and enzalutamide in patients with metastatic castration-resistant prostate cancer. The study involved a real-world analysis of 1,465 patients who received these treatments in various ways.
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| Molecular Features of Circulating Tumor Cells Associated with Response to 177LuPSMA + Pembrolizumab for Metastatic Castration-Resistant Prostate Cancer
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| David Goode, MD, Ph.D.
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| David Goode presented findings from the PRINCE trial, which focused on molecular features of circulating tumor cells associated with the response to 177LuPSMA + pembrolizumab treatment in mCRPC. This phase I trial enrolled 37 patients and assessed their PSA levels, CTC counts, and other characteristics.
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| Prognostic Value of Neutrophil-to-Lymphocyte Ratio and Lymphopenia in Patients with mCRPC Treated with 177Lu-PSMA-617: VISION Post Hoc Analysis
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| Xiao X. Wei, MD, MAS
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| Xiao Wei presents a post hoc analysis of the VISION trial that assessed the prognostic value of neutrophil-to-lymphocyte ratio and lymphopenia in patients with mCRPC treated with 177Lu-PSMA-617. The analysis showed that baseline neutrophil-to-lymphocyte ratio ≥ 3 and absolute lymphocyte count < 1.0 x 103/μl were prognostic factors for worse overall survival and radiographic progression-free survival in mCRPC patients, regardless of the treatment received.
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