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HIGHLIGHTS FROM THE 2024 AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING |
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| ADT Sparing Approaches in the Metastatic Hormone-Sensitive and Castrate-Resistant Spaces
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| Karen Autio, MD, MSc
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| Karen Autio presented on ADT-sparing approaches in metastatic castrate-sensitive and castrate-resistant prostate cancer. She highlighted the significant toxicities associated with ADT and discussed the role of stereotactic ablative radiotherapy and metastasis-directed therapy in minimizing treatment burden while maintaining efficacy.
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| Bone Resorptive Agents and Their Appropriate Use and Timing
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| Ashwin Sachdeva, PhD, MBBS, MSc, MRCS
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| During the session addressing techniques to minimize the effects of ADT while exploring alternatives in prostate cancer management, Dr. Ashwin Sachdeva discussed the appropriate use and timing of bone resorptive agents in patients with advanced prostate cancer.
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| Patient-Centered Approaches to Improve Quality of Life and Mitigate the Adverse Effects of Androgen Deprivation Therapy
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| Brian D. Gonzalez, Ph.D.
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| Brian Gonzalez discussed patient-centered approaches to improve quality of life and mitigate the adverse effects of ADT. Behavioral interventions, such as cognitive behavioral therapy (CBT) and physical activity, can help mitigate adverse effects of ADT, including fatigue, depressive symptoms, and sleep disruption. Behavioral strategies play a critical role in patient-centred clinical practice and can help improve health related quality of life.
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| Blood-Based Markers of Differential Efficacy of Bipolar Androgen Therapy and Enzalutamide in the Randomized TRANSFORMER Trial
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| Samuel Denmeade, MD
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| Samuel Denmeade presented findings from the TRANSFORMER trial comparing bipolar androgen therapy with enzalutamide in castration-resistant prostate cancer. The study showed that progression-free survival 2 was significantly longer with BAT followed by enzalutamide compared to the reverse sequence. Analysis of circulating tumor DNA revealed that patients with androgen receptor alterations may benefit more from BAT.
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| Clinical Utility of Transcriptomic Signatures to Identify Androgen Receptor and Neuroendocrine Signaling in Prostate Cancer
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| Yu-Wei Chen, MD, MS
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| Yu-Wei Chen discussed the clinical utility of transcriptomic signatures in identifying androgen receptor (AR) and neuroendocrine signaling in prostate cancer. The study characterized molecular features across different prostate cancer histologies and metastatic sites using AR signaling and neuroendocrine transcriptomic signatures.
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| Prognostic PSMA-PET PROMISE Nomograms for Patients with Prostate Cancer
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| Wolfgang Fendler, MD
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| Wolfgang Fendler discussed the prognostic value of PSMA-PET PROMISE nomograms for patients with prostate cancer. These nomograms, based on PSMA-PET imaging and other clinical parameters, accurately predicted overall survival across various disease stages. They outperformed traditional clinical risk scores and hold promise for improving risk stratification and treatment decision-making in prostate cancer patients.
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| Oncogenic Alteration Rates, Race, and Prostate Cancer-Specific Mortality in Veterans with Metastatic Prostate Cancer Undergoing Somatic Tumor Next Generation Sequencing
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| Luca Faustino Valle, MD
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| Luca Faustino Valle presented a retrospective cohort study exploring the association between oncogenic alteration rates, race, and prostate cancer-specific mortality in veterans with metastatic prostate cancer undergoing somatic tumor next-generation sequencing (NGS). The study found significant differences in alteration rates of several oncogenic genes and pathways based on patient race/ethnicity, with Black patients exhibiting distinct genomic alteration profiles compared to White patients.
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| ProstACT GLOBAL: A Phase 3 Study of Best Standard of Care with and Without 177Lu-DOTA-Rosopatamab (TLX591) for Patients with PSMA Expressing mCRPC Progressing Despite Prior Treatment with a Novel Androgen Axis Drug
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| A. Oliver Sartor, MD
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| Oliver Sartor presented the ProstACT GLOBAL phase 3 trial, which investigates the safety and efficacy of combining 177Lu-DOTA-rosopatamab (TLX591) with the best standard of care for patients with PSMA-expressing metastatic castration-resistant prostate cancer (mCRPC) that has progressed despite prior treatment with novel androgen axis drugs. TLX591 is a PSMA-targeted radio-antibody drug conjugate with demonstrated anti-tumor effects and overall survival benefits in earlier studies.
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| CLARIFY: Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Patients with High-Risk Prostate Cancer Prior to Radical Prostatectomy (A Phase 3 Diagnostic Study)
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| Michael Gorin, MD
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| Michael Gorin presented CLARIFY, a phase III diagnostic study evaluating positron emission tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy. The study aims to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET for detecting regional nodal metastases in untreated prostate cancer patients with high-risk features undergoing radical prostatectomy with pelvic lymph node dissection.
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| Prognostic Validation of a Digital Pathology-Based Multi-Modal Artificial Intelligence Biomarker in Patients with Metastatic Hormone-Sensitive Prostate Cancer from the CHAARTED Trial (ECOG-ACRIN EA3805) |
| Mark Markowski, MD, PhD |
| Mark Markowski presented the validation of the ArteraAI multi-modal artificial intelligence biomarker in mHSPC using data from the CHAARTED trial. The study confirmed that the MMAI biomarker is prognostic for overall survival in mHSPC patients, even after adjusting for treatment, metastatic burden, and stage at diagnosis. Future research aims to optimize the MMAI model for advanced prostate cancer and assess its potential to predict docetaxel benefit. |
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| EMBARK Post Hoc Analysis of Sexual Activity PROs in Patients Who Were Sexually Active or Interested in Sex at Baseline
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| Stephen J. Freedland, MD
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| Stephen Freedland presented a post hoc analysis of the EMBARK trial, assessing sexual activity outcomes in patients with non-metastatic hormone-sensitive prostate cancer who were sexually active or interested in sex at baseline. The analysis showed that enzalutamide monotherapy better preserved sexual activity, interest, satisfaction, and erectile function compared to leuprolide alone, whereas enzalutamide combined with leuprolide adversely affected erectile function.
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| Willingness of Patients with Biochemically Recurrent Prostate Cancer with Positive 18F-DCFPyL PET/CT PSMA to Monitor Without Treatment |
| Monique Williams, MS, PMP |
| Monique Williams presented a study on the willingness of patients with biochemically recurrent prostate cancer, identified via 18F-DCFPyL PET/CT PSMA, to monitor their condition without immediate treatment. The study involved 86 patients with a median PSA of 2.55 ng/mL and found that 89.5% had positive PSMA PET findings, with 87% of these patients choosing to monitor their disease rather than undergo immediate treatment. |
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| SECuRE: A Dose Escalation/Expansion Study to Assess the Anti-Tumor Efficacy of 67Cu-SAR-bisPSMA in Patients with Metastatic Castrate Resistant Prostate Cancer |
| Geoffrey Johnson, MD, PhD |
| The SECuRE trial, presented by Dr. Geoffrey Johnson at ASCO 2024, is a phase I/IIa study assessing the safety and anti-tumor efficacy of 67Cu-SAR-bisPSMA in patients with metastatic castrate-resistant prostate cancer (mCRPC). Preliminary results show no dose-limiting toxicities and promising safety and efficacy profiles, with the trial currently expanding to more sites in the US and Australia. |
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| ALADDIN: Evaluation of Darolutamide Addition to ADT and Radiation Therapy in Newly Diagnosed Prostate Cancer with Pelvic Lymph Nodes Metastases |
| Stephane Oudard, MD |
| The ALADDIN trial, presented by Dr. Stephane Oudard, is a phase 3 study evaluating the addition of darolutamide to ADT and radiation therapy in newly diagnosed prostate cancer patients with pelvic lymph node metastases. The trial, involving 152 patients, aims to assess whether adding darolutamide improves failure-free survival compared to ADT and radiotherapy alone. |
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| Randomized PROSTATE-IQ Trial to Reduce ADT Treatment Burden for Patients with Biochemical Recurrence After Prostatectomy
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| Karen Hoffman, MD, MHSc, MPH
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| Karen Hoffman introduced the PROSTATE-IQ trial, aiming to alleviate the treatment burden of androgen deprivation therapy for patients experiencing biochemical recurrence post-radical prostatectomy. The trial employs ArteraAI Post-RP Test to categorize patients into "Artera Low" and "Higher Risk" groups and explores apalutamide-based therapies as alternatives to traditional ADT.
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| A Phase 2 Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy (RP) in Patients with Unfavorable Intermediate-Risk or High-Risk Prostate Cancer with BRCA1/2 Gene Alterations (NePtune)
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| Rana McKay, MD
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| Rana McKay presented the NePtune trial, a phase II study investigating the use of neoadjuvant PARP inhibition with olaparib followed by radical prostatectomy in patients with unfavorable intermediate- or high-risk prostate cancer harboring BRCA1/2 gene alterations. The trial aims to assess the efficacy of this treatment strategy in achieving pathologic complete response or minimal residual disease and involves 32 patients receiving olaparib and an LHRH analog for six months before undergoing surgery.
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| Nivolumab and Ipilimumab for Metastatic Prostate Cancer with an Immunogenic Signature: The NEPTUNES Multi-Centre Two-Cohort, Biomarker-Selected Phase 2 Trial
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| Mark Linch, MD, PhD, MBChB
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| Mark Linch presented results from the NEPTUNES trial, a phase 2 study evaluating nivolumab and ipilimumab in metastatic prostate cancer patients with an immunogenic signature. The trial included two cohorts with different dose schedules, showing promising anti-tumor activity with composite response rates of 40% in Cohort 1 and 25% in Cohort 2. Responses were enriched in patients with specific biomarkers like mismatch repair deficiency and BRCA1/2 mutations.
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| COBRA: Assessment of Safety and Efficacy of 64Cu-SAR-bisPSMA in Patients with Biochemical Recurrence of Prostate Cancer Following Definitive Therapy
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| Luke Nordquist, MD, FACP
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| Luke Nordquist presented results from the COBRA study, which assessed the safety and efficacy of 64Cu-SAR-bisPSMA in detecting prostate cancer lesions in patients with biochemical recurrence following definitive therapy. The study concluded that 64Cu-SAR-bisPSMA is safe, effective, and offers advantages over current PSMA tracers, especially in detecting smaller lesions and providing next-day imaging capabilities.
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| ARV-766, a PROTAC Androgen Receptor Degrader, in mCRPC: Initial Results of a Phase 1/2 Study
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| Daniel P. Petrylak, MD,
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| Daniel Petrylak presented initial findings from a phase 1/2 study of ARV-766 in mCRPC. The study demonstrated that ARV-766, a PROTAC androgen receptor degrader, was well tolerated and showed promising clinical activity, particularly in patients with tumors harboring AR ligand-binding domain mutations, with a PSA50 of 43%. These results suggest that ARV-766 warrants further development in advanced prostate cancer.
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| DeLLpro-300: Phase 1b Study of Tarlatamab in De Novo or Treatment-Emergent Neuroendocrine Prostate Cancer
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| Rahul Aggarwal, MD
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| Rahul Aggarwal presented findings from a phase 1b study of tarlatamab in patients with neuroendocrine prostate cancer (NEPC). The study showed that tarlatamab, a bispecific T-cell engager immunotherapy targeting delta-like ligand 3 (DLL3), demonstrated a manageable safety profile, with cytokine release syndrome being the most common adverse event.
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| A Phase 1 Study of JNJ-69086420 (JNJ-6420), an Actinium-225 (225Ac)-Labeled Antibody Targeting Human Kallikrein 2, for mCRPC
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| Michael Morris, MD
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| Michael Morris presented findings from a phase 1 study of JNJ-69086420, an actinium-225 (225Ac)-labeled antibody targeting human kallikrein 2, for metastatic castration-resistant prostate cancer. The study showed that JNJ-6420 elicited deep and durable biochemical responses in mCRPC patients, with thrombocytopenia and interstitial lung disease being dose-limiting but manageable with a cumulative dose cap and adaptive dosing schedule.
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