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ASCO GU 2021

ASCO GU 2021: Olaparib Efficacy in Patients with Metastatic Castration-Resistant Prostate Cancer Carrying Circulating Tumor DNA Alterations in BRCA1, BRCA2 or ATM: Results from the PROfound Study

(UroToday.com) Deficiencies in an apparatus to repair double-strand DNA breaks can be exploited in clinical practice. The homologous recombination (HR) program is executed by a variety of proteins and, recently, the US Food and Drug Administration (FDA) has approved two poly ADP-ribose polymerase (PARP) inhibitors (olaparib1 and rucaparib2) for treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). In both of these studies, qualifying genomic alterations were assayed in tumor tissue-based assays. In some patients, collection of metastatic tissue is not possible or the amount of tissue, while adequate for histological diagnosis is insufficient for sequencing assays. The plasma in mCRPC can contain circulating tumor DNA (ctDNA) and alterations observed in this compartment have demonstrated reliable concordance with tumor biopsies,3 with the added advantage of avoiding an invasive biopsy and, at times, reflecting a larger pool of metastatic clones.

ASCO GU 2021: Racial Disparities in Efficacy of First-Line Abiraterone in Metastatic Castrate-Resistant Prostate Cancer

(UroToday.com) It is increasingly well-known that African American (AA) men as a group experience higher incidence of prostate cancer and worse prostate cancer-specific outcomes. The reasons for this are the point of ongoing investigations, with contributors to disparity from biological and non-biological factors. Within the realm of differential biology lie the data that AA men have demonstrated more pronounced prostate-specific antigen (PSA) responses as compared to white counterparts when treated with abiraterone acetate in the metastatic castration-resistant setting (mCRPC),1 and with subsequent prospective studies indicating improved progress-free survival in this same population (as compared to non-Hispanic white patients).2 Dr. Mallika Marar and colleagues sought to determine, retrospectively, whether similar demographic-based differences in the efficacy of abiraterone acetate exist in real-world practice.

ANZUP Reports A New Class of Effective Therapy for Men with Metastatic Castration-Resistant Prostate Cancer

San Francisco, CA (UroToday.com) -- The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) reports the results of its “TheraP” (ANZUP 1603) clinical trial at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Virtual Symposium.

ASCO GU 2021: 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

(UroToday.com) At the 2021 American Society of Clinical Oncology Genitourinary Cancers annual meeting (ASCO GU), Dr. Daniel George and colleagues 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,1 relugolix demonstrated suppression of testosterone to castrate levels in 96.7% of patients, which was superior to leuprolide, with a 54% lower risk of major adverse cardiovascular events relative to leuprolide. Relugolix is a first-in-class Federal Drug Administration (FDA) approved, oral, highly selective, GnRH receptor antagonist that is given once daily with an effective half-life of 25 hours. To characterize the impact of concomitant prostate cancer treatments with the use of relugolix in advanced prostate cancer from the HERO study, a subgroup analysis for patients receiving various therapies was undertaken. The HERO study allowed concomitant treatments in patients who developed disease progression within the 48-week treatment period. 

ASCO GU 2021: Multi-Institutional Evaluation of the Clinical Outcomes and Genomic Correlates of African Americans with Metastatic Castration-Sensitive Prostate Cancer

(UroToday.com) It remains that African American (AA) men experience higher rates of incidence of prostate cancer and prostate cancer-specific mortality than do their non-AA counterparts. Multifaceted efforts are underway at several centers to isolate and address the biological and non-biological contributors to these fundamental health disparities. Among a gap between AA and non-AA prostate cancer patients is the rates of clinical trial enrollment.1 As advanced therapies have improved the outcomes for patients with metastatic castration-sensitive prostate cancer (mCSPC), the trials demonstrating these benefits have continued to underrepresent the AA community. In the absence of prospective data, Dr. Freeman and colleagues used retrospective data from six academic cancer centers to describe the clinical and genomic landscape of AA mCSPC.

Weill Cornell Medicine Experts Presenting at 2021 ASCO GU

San Francisco, CA (UroToday.com) -- Poster session begins Thursday, February 11 at 8:00AM ET


Prostate Cancer - Advanced Disease Poster Session:

Real-world clinical outcomes study of sequential novel antihormonal therapy (NAH) or radium-223 (Ra-223) treatment of metastatic castration-resistant prostate cancer (mCRPC) that progressed after first-line NAH. (Abstract 48)
PROSPER subgroup analysis by age and region: Overall survival and safety in men with nonmetastatic castration-resistant prostate cancer receiving androgen deprivation therapy plus enzalutamide. (Abstract 84)

Advanced Prostate Cancer Trials in Progress Poster Session:

A phase I/II dose-escalation study of fractionated and multiple dose 225Ac-J591 for progressive metastatic castration-resistant prostate cancer (mCRPC). (Abstract TPS188)

Urothelial Carcinoma Poster Session:

Avelumab (Ave) first-line (1L) maintenance plus best supportive care (BSC) versus BSC alone for advanced urothelial carcinoma (UC): JAVELIN Bladder 100 subgroup analysis based on duration and cycles of 1L chemotherapy. (Abstract 438)
NOTE - This presentation is also featured in the urothelial carcinoma clinical trials poster highlights session on Friday, February 12 at 8:00 AM ET.

Cora N. Sternberg, M.D. Clinical Director of the Englander Institute of Precision Medicine at Weill Cornell Medicine and NewYork-Presbyterian
Dr. Sternberg’s areas of expertise:
  • Bladder cancer
  • Genomics
  • Immunotherapy
  • Kidney cancer
  • Prostate cancer
  • Testicular cancer
  • Urologic cancer
  • Urothelial cancer

Prostate Cancer - Advanced Disease Poster Session:

The role of androgen deprivation therapy on the clinical course of COVID-19 infection in men with prostate cancer (Abstract 41)
Survival outcomes in patients with metastatic castration-sensitive prostate cancer (mCSPC): A real-world evidence study (Abstract 46)

Advanced Prostate Cancer Trials in Progress Poster Session:

A phase I/II dose-escalation study of fractionated and multiple dose 225Ac-J591 for progressive metastatic castration-resistant prostate cancer (mCRPC). (Abstract TPS188)

Scott T. Tagawa, MD, MS, FACP, Medical Director of the Genitourinary Oncology Research Program at Weill Cornell Medicine and NewYork-Presbyterian
Dr. Tagawa’s areas of expertise:
  • Bladder Cancer
  • Immunotherapy
  • Kidney Cancer
  • Medical Oncology
  • Prostate Cancer
  • Testicular Cancer
  • Thrombosis
  • Urologic Cancer

Urothelial Carcinoma Poster Session:

Single-cell DNA targeted sequencing (scDNA-seq) to test therapeutic vulnerabilities in urothelial cancer (UC) patient-derived organoids (PDO). (Abstract 464)

Bishoy M. Faltas, MD, Genitourinary Oncologist at Weill Cornell Medicine and NewYork-Presbyterian, Director of Bladder Cancer Research, Englander Institute for Precision Medicine
Dr. Faltas’ areas of expertise:
  • Bladder Cancer
  • Cancer of Ureter
  • Genomics
  • Immunotherapy
  • Kidney Cancer
  • Prostate Cancer
  • Urethral Cancer
Source: American Society of Clinical Oncology Genitourinary Cancer Symposium. (2021, February 10). Weill Cornell Medicine Experts Presenting at 2021 ASCO GU [Press release]. Retrieved from ASCO Meeting Library ASCO GU 2021

Related Content:
The PROSPER Trial: Enzalutamide Demonstrates Significant Improvement in Overall Survival in Nonmetastatic Castration-Resistant Prostate Cancer - Cora Sternberg
JAVELIN Bladder 100: Results of First-line Maintenance Therapy Plus Best Supportive Care Demonstrates Significant Prolonged OS in Advanced Urothelial Cancer - Cora Sternberg

Foundation Medicine and Its Collaborators Announce New Study Results Further Demonstrating the Clinical Utility of Blood-Based Comprehensive Genomic Profiling in Patients with Advanced Prostate Cancer

Results from the study assessing concordance of genomic alterations identified by liquid and tissue biopsy published in Clinical Cancer Research and to be presented at the American Society of Clinical Oncology 2021 Genitourinary Cancers Symposium
San Francisco, CA (UroToday.com) -- Foundation Medicine, Inc. and its collaborators announced results from a prostate cancer study evaluating the landscape of genomic alterations identified by liquid biopsy in over 3,000 patients, as well as assessing concordance of liquid and tissue biopsy in over 800 patients. The study demonstrated high concordance between targetable alterations identified using circulating tumor DNA (ctDNA) and tissue-based comprehensive genomic profiling (CGP) in patients with metastatic castration-resistant prostate cancer (mCRPC). It also found that, in many patients, liquid biopsy detects more acquired resistance mechanisms than tissue biopsy. The study, “Genomic analysis of circulating tumor DNA (ctDNA) in 3,334 patients with advanced prostate cancer identifies targetable BRCA alterations and AR resistance mechanisms,” was published online in Clinical Cancer Research, a journal of the American Association for Cancer Research. These data will also be presented as a poster highlight on Feb. 11 at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU).

Nivolumab in Combination with Cabozantinib Shows Sustained Survival and Response Rate Benefits as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma in the Phase 3 CheckMate -9ER Trial

With a median follow-up of two years, OPDIVO in combination with CABOMETYX continues to demonstrate superior progression-free survival, overall survival and objective response rate compared to sunitinib

Patients treated with OPDIVO in combination with CABOMETYX report significantly improved health-related quality of life in a separate analysis from CheckMate -9ER

Data showing ongoing efficacy benefits and patient-reported outcomes will be presented at the 2021 Genitourinary Cancers Symposium


San Francisco, CA (UroToday.com) -- Bristol Myers Squibb and Exelixis, Inc. announced results from new analyses from the pivotal Phase 3 CheckMate -9ER trial, demonstrating clinically meaningful, sustained efficacy benefits as well as quality of life improvements with the combination of OPDIVO® (nivolumab) and CABOMETYX® (cabozantinib) compared to sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC). These data will be presented in two posters at the virtual American Society of Clinical Oncology (ASCO) 2021 Genitourinary Cancers Symposium from February 11 to 13, 2021, and featured in the Poster Highlights Session on February 13, 2021, from 9:00 a.m. – 9:45 a.m. EST.

Janssen Announces Treatment with Apalutamide Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer

Final analysis from Phase 3 TITAN study demonstrated ERLEADA® provided statistically significant overall survival benefit and consistent safety profile in patients with advanced prostate cancer, regardless of extent of disease

San Francisco, CA (UroToday.com) -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the final analysis of the Phase 3 TITAN study, which demonstrated the continued statistically significant benefit of the addition of ERLEADA® (apalutamide) to androgen deprivation therapy (ADT) in overall survival (OS) in patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of extent of disease, when compared to placebo plus ADT.1 Results will be featured in an oral presentation at the American Society of Clinical Oncology's Genitourinary (ASCO GU) Cancers Symposium, taking place virtually February 11-13, 2021 (Abstract #11; Rapid Abstract Session: Prostate Cancer, February 11, 3:30 PM-4:15 PM EST).

Increase in Metastatic Prostate Cancer Diagnoses Seen After Reduction in PSA Screening in United States

ASCO Perspective

“This study suggests that reduced PSA screening may come at the cost of more men presenting with metastatic prostate cancer. Patients should discuss the risks and benefits associated with PSA screening with their doctor to identify the best approach for them,” said Robert Dreicer, MD, MS, MACP, FASCO, ASCO expert in genitourinary cancers.
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