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Prostate Cancer Highlights from the 2021 Genitourinary Cancers Symposium |
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| Biomarker Analysis from a Randomized Phase II Study of Olaparib with or Without Cediranib in Men with Metastatic Castration-Resistant Prostate Cancer
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| Rana R. McKay, MD
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| Rana McKay presented a phase 2 study of olaparib versus olaparib in combination with cediranib, an oral antagonist of VEGF receptors 1-3. The rationale from this study comes from preclinical and clinical studies showing that anti-angiogenic agents can result in a hypoxic tumor environment that downregulates the expression of homologous recombination genes, as well as studies in other cancers showing antitumor activity of cediranib and olaparib in combination.
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| Clinical Conundrums of Genomically Driven Prostate Cancer - Case Panel Discussion
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| Michael Morris, MD; Ganesh Palapattu, MD, FACS; Maria Isabel Carlo, MD; Alejandro Berlin MD, MSc
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| In this case panel discussion in the Clinical Conundrums of Genomically Driven Prostate Cancer session, a patient case was presented. Maria Carlo provided the medical oncologist and geneticist discussion, urologist, Ganesh Palapattu discussed the incidence of germline mutations in patients with localized prostate cancer, and Alejandro Berlin presented the radiation oncologist discussion, addressing the risk of increased radiotherapy toxicity including second primary malignancy in patients with germline DNA damage repair defects. |
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| Final Results from ACIS, a Randomized, Placebo-Controlled Double-Blind Phase 3 Study of Apalutamide and Abiraterone Acetate plus Prednisone (AAP) Versus AAP in Patients with Chemo-Naive Metastatic Castration-Resistant Prostate Cancer |
| Dana Rathkopf, MD |
| Dana Rathkopf presented results of the ACIS trial which met its primary outcome of showing an rPFS benefit for abiraterone plus apalutamide as first line therapy in mCRPC. The secondary endpoint of overall survival was similar between the treatment arms. While more treatment related adverse events were noted in the combination arm, the overall QoL as measured by FACT-P was similar between arms. |
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| Molecular Determinants Associated with Long-Term Response to Apalutamide in Nonmetastatic Castration-Resistant Prostate Cancer
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| Felix Y. Feng MD
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| In this presentation, Felix Feng described the transcriptomic characteristics of the extremes of response in the SPARTAN trial. Time to progression events (metastasis or death) were divided into quartiles, with long term responders defined as no events until the fourth time quartile, and early progressors having events in the first quartile of time. In total, 233 tumors from radical prostatectomy or diagnostic biopsy were included in this biomarker analysis, with a mean time from sample generation to analysis of 6.7 years.
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| Discussion: Molecular Correlates of Response to Apalutamide in nmCRPC and Final Results from ACIS, Androgen Annihilation with Abiraterone and Apalutamide in Chemo-Naïve mCRPC
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| Joshi J. Alumkal, MD
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| In this discussion, Dr. Alumkal discussed two presentations looking at molecular correlates of response to apalutamide in non-metastatic castration-resistant prostate cancer (nmCRPC) and data from the ACIS trial of androgen annihilation with abiraterone and apalutamide in chemotherapy naïve mCRPC.
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| Concordance of BRCA1, BRCA2, and ATM Mutations Identified in Matched Tumor Tissue and Circulating Tumor DNA in Men with Metastatic Castration-Resistant Prostate Cancer Screened in the PROfound Study
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| Kim N. Chi, MD, FRCP(C)
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| In plenary abstract presentation in the Poster Highlights Session: Prostate Cancer session at the 2021 ASCO GU Cancers Symposium, Kim Chi and colleagues evaluated the utility of plasma-derived ctDNA to identify deleterious BRCA and ATM mutations in screened patients from PROfound.
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| Exploratory Gene-By-Gene Analysis Of Olaparib In Patients With Metastatic Castration-Resistant Prostate Cancer: PROfound |
| Johann de Bono, MD, Ph.D. |
| The phase 3 PROfound study demonstrated improved overall survival in men with mCRPC who had progressed on prior anti-androgen therapy and harbor deleterious alteration in BRCA1, BRCA2, and ATM. A radiographic progression-free survival benefit was also demonstrated in an overall group of patients harboring a deleterious alteration in selected homologous recombination (HR) genes. In this abstract, Johann de Bono presented results of exploratory analyses examining the relationship between individual gene alterations and clinical outcomes. |
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| Randomized Phase II Trial of Radium-223 plus Enzalutamide Versus Enzalutamide Alone in mCRPC: Final Efficacy and Safety Results
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| Adam Kessel
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| The clinical benefit of radium-223 has been demonstrated in patients with metastatic castration-resistant prostate cancer (mCRPC) in the ALSYMPCA randomized placebo-controlled trial. Over the last nearly decade since the publication of this landmark trial, combination therapy in patients with mCRPC is of great interest for improving efficacy but must be done in a safe manner for these patients. At the GU ASCO 2021 annual meeting, medical student, Adam Kessel shares results of the final efficacy and safety results for this trial.
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| The Impact of Concomitant Prostate Cancer Therapy on Efficacy and Safety of Relugolix vs Leuprolide in Men With Advanced Prostate Cancer: Subgroup Analysis, the Phase III HERO Study |
| Daniel J. George, MD |
Daniel George presented a subgroup analysis assessing the impact of concomitant prostate cancer therapy on the safety and efficacy of the oral GnRH receptor antagonist relugolix versus leuprolide in men with advanced prostate cancer in the phase 3 HERO study. No clinically relevant differences in adverse events were observed between patients with or without concomitant use of enzalutamide, docetaxel or radiation therapy in either treatment group.
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| Final Analysis Results from TITAN: A Phase III Study of Apalutamide Versus Placebo In Patients with Metastatic Castration-Sensitive Prostate Cancer Receiving ADT
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| Kim Chi, MD, FRCP(C)
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| In this presentation, Kim Chi presented follow-up data from a median of 44 months of clinical follow-up. This included an intention to treat analysis of all patients, though 40% of the placebo group crossed over from placebo to apalutamide after the initial unblinding at 22.7 months of follow-up. The benefit of apalutamide on overall survival was confirmed, with a similar hazard ratio for death – HR 0.65, 95% CI 0.53 – 0.79, p < 0.001.
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| KEYNOTE-365 Cohort B: Pembrolizumab Plus Docetaxel And Prednisone In Abiraterone Or Enzalutamide-Pretreated Patients with mCRPC: New Data After An Additional Year Of Follow-Up
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| Leonard Appleman, MD, Ph.D.
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| Pembrolizumab, an anti-PD-1 antibody, has antitumor activity as monotherapy in patients with heavily pre-treated, PD-L1 positive advanced prostate cancer as well as mCRPC patients regardless of PD-L1 expression status. KEYNOTE-365 is a 4-cohort study evaluating the combination of pembrolizumab in combination with multiple agents, as shown below. In this presentation, Leonard Appleman shares updated data with a median time of follow-up of 32.4 months.
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| CheckMate 9KD Arm B Final Analysis: Efficacy and Safety of Nivolumab Plus Docetaxel For Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer
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| Karim Fizazi, MD, Ph.D.
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| Karim Fizazi presents final analysis of Arm B of the CheckMate 9KD trial. The CheckMate 9KD trial is a multi-arm open label phase 2 study evaluating the efficacy of the anti-PD-1 antibody nivolumab in combination with other therapies such as docetaxel, rucaparib or enzalutamide in metastatic castration-resistant prostate cancer (mCRPC). The rationale for the combination of nivolumab with docetaxel is that docetaxel is a standard of care therapy for mCRPC that may potentiate anti-tumor immune responses.
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| PI3K/AKT Pathway Biomarkers Analysis From The Phase III IPATential150 Trial Of Ipatasertib Plus Abiraterone In Metastatic Castration-Resistant Prostate Cancer |
| Johann de Bono, MB, ChB, FRCP, MSc, Ph.D., FMedSci |
| In this study, Johann de Bono presents an evaluation of several questions in regards to the IPATential150 trial: (1) What is the impact of differential IHC PTEN loss status cutoffs on treatment efficacy, (2) What is the concordance between PTEN assessment by immunohistochemistry and next generation sequencing (NGS), (3) How does PTEN loss by next generation sequencing relate to outcomes, and (4) How do other genomic alterations in the PI3K/AKT pathway associate with treatment outcomes with ipatasertib. |
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| Prospective Randomized Trial of Gene Expression Classifier Utility Following Radical Prostatectomy (G-MINOR) |
| Todd M. Morgan, MD
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| The Decipher classifier may be applied to prostate tumor tissue to help predict which patients undergoing prostatectomy may benefit the most from post-operative radiotherapy. To evaluate this, the G-MINOR study enrolled patients with pT3+ and/or surgical margin positive disease at the time of prostatectomy who had a subsequent PSA drop to less than 0.1.
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| Genomic Landscape of Advanced Prostate Cancer In Racial Minority Populations: Real-World Experience In A Safety-Net Hospital Oncology Clinic |
| Tamer Khashab, MD |
| Tamer Khashab presented genomic data derived from a retrospective analysis of patients treated at a community-focused academic healthcare system in Texas that serves a higher percentage of Hispanic and African American patients with prostate cancer. |
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| To view our full coverage of the 2021 ASCO GU Symposium, visit the Conference Coverage section on UroToday.com
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