ASCO GU 2021

ASCO GU 2021: CTC Counts as a Biomarker of Prognosis and Response in Metastatic Castration-Resistant Prostate Cancer (mCRPC) from the CARD Trial

(UroToday.com) There have been many advances in the field of systemic therapy for advanced prostate cancer in the past 15 years. While, prior to the publication of TAX-327, there were no available treatments with proven life-prolonging benefits, we now have many treatments available with demonstrable improvements in overall survival. Thus, we now face the question of how to sequence these agents. In the prospective CARD trial (NCT02485691), cabazitaxel treatment demonstrated significantly improved progression-free survival (rPFS) and overall survival (OS) compared to abiraterone acetate or enzalutamide among patients with metastatic castration resistant prostate cancer (mCRPC) who had previously received docetaxel and progressed within 12 months of starting the alternative androgen-axis inhibitor.

ASCO GU 2021: The CLEAR Study of Lenvatinib Plus Pembrolizumab or Everolimus vs Sunitinib and the SWOG 1500 Trial of Sunitinib, Cabozantinib, Crizotinib, and Savolitinib in Advanced Kidney Cancer: Discussion

(UroToday.com) Following presentations by Dr. Robert Motzer discussing results of the CLEAR study of lenvatinib plus pembrolizumab or everolimus versus sunitinib in first-line treatment of advanced renal cell carcinoma and by Dr. Sumanta Pal looking at the SWOG 1500 trial of sunitinib, cabozantinib, crizotinib, and savolitinib in patients with metastatic papillary renal cell carcinoma, Dr. Stephanie Berg provided a discussion of these data in the Oral Abstract Session: Renal Cell Cancer session at the 2021 ASCO GU Cancers Symposium.

ASCO GU 2021: MK-6482 in Patients with Clear Cell Renal Cell Carcinoma: Discussion

(UroToday.com) Following presentations by Dr. David Bauer discussing phase I/II data for the oral HIF-2 α inhibitor MK-6482 in patients with advanced clear cell renal cell carcinoma and by Dr. Toni Choueiri looking at the combination of MK-6482 and cabozantinib in patients with previously treated clear cell renal cell carcinoma, Dr. Braun provided a discussion of these data in the Oral Abstract Session: Renal Cell Cancer session at the 2021 ASCO GU Cancers Symposium.

ASCO GU 2021: Back to Basics in Personalization: Returning to PTEN

(UroToday.com) In a plenary presentation in the Progress and Promise in Treatment Personalization for Advanced Prostate Cancer session at the 2021 ASCO GU Cancers Symposium, Dr. Martin Gleave presented on the role of PTEN in personalizing prostate cancer.

ASCO GU 2021: 177Lu-PSMA-617 (LuPSMA) Versus Cabazitaxel in Metastatic Castration-Resistant Prostate Cancer Progressing After Docetaxel: Updated Results Including Progression-Free Survival and Patient-Reported Outcomes (TheraP ANZUP 1603)

(UroToday.com) The field of advanced prostate cancer has rapidly progressed over the past 15 years. Prior to the publication of TAX-327, there were no proven life-prolonging therapies for patients with metastatic castration-resistant prostate cancer (mCRPC). Since that time, there have been many new agents that have proven survival benefits including taxane-based chemotherapy, agents targeting the androgen axis, and bone-targeting agents. Most recently, combining advances in targeted imaging with therapeutic intervention, the field of theranostics has begun to flourish in prostate cancer. The TheraP trial was designed to assess the role of LuPSMA, compared to cabazitaxel, in men who had progressed following treatment with docetaxel of mCRPC. A previous report demonstrated improved PSA response rates among those treated with LuPSMA (PSA reduction ≥50% of 66% vs. 37%).

ASCO GU 2021: Biomarker Analysis from a Randomized Phase II Study of Olaparib with or Without Cediranib in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

(UroToday.com) The field of advanced prostate cancer has rapidly progressed over the past 15 years. Prior to the publication of TAX-327, there were no proven life-prolonging therapies for patients with metastatic castration-resistant prostate cancer (mCRPC). Since that time, there have been many new agents that have proven survival benefits including taxane-based chemotherapy, agents targeting the androgen axis, and bone-targeting agents. Most recently, there has been interested in developing targeted therapies. Among patients with homologous recombination repair (HRR) mutations, the use of poly (ADP-ribose) polymerase (PARP) inhibitors (including olaparib and rucaparib) has proven benefit. However, despite all these advances, mCRPC remains an uncurable disease state and there is room for further benefit.

ASCO GU 2021: 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

(UroToday.com) The field of advanced prostate cancer has rapidly progressed over the past 15 years. Prior to publication of TAX-327, there were no proven life-prolonging therapies for patients with metastatic castration-resistant prostate cancer (mCRPC). Since that time, there have been many new agents that have proven survival benefits including taxane-based chemotherapy, agents targeting the androgen axis, and bone-targeting agents. In spite of castration resistance, mCRPC remains driven by activated androgen receptors and elevated intratumoral androgens. Thus, maximal androgen-axis targeting treatment may require dual inhibition of these two pathways. To this end, in a plenary abstract presentation in the Oral Abstract Session: Prostate Cancer session at the 2021 ASCO GU Cancers Symposium, Dr. Rathkopf presented results of the ACIS trial assessing the combination of apalutamide + abiraterone acetate (two approved prostate cancer treatment with distinct receptor inhibition and ligand suppression actions, respectively) as compared to abiraterone acetate alone in patients with chemo-naive mCRPC.

ASCO GU 2021: Molecular Determinants Associated with Long-Term Response to Apalutamide in nmCRPC and Final Results from the ACIS Phase 3 Study - Discussion

(UroToday.com) Following presentations by Dr. Felix Feng assessing molecular determinants of response to apalutamide in patients with non-metastatic prostate cancer and by Dr. Dana Rathkopf looking at the ACIS trial combining apalutamide and abiraterone acetate in patients with newly diagnosed metastatic castration-resistant prostate cancer, Dr. Joshi Alumkal provided a discussion of these data in the Oral Abstract Session: Prostate Cancer session at the 2021 ASCO GU Cancers Symposium.

ASCO GU 2021: Australia and New Zealand Outcomes of High-Dose Chemotherapy and Stem Cell Transplantation for Relapsed or Refractory Germ Cell Tumors from 1999 to 2019: Multicenter Registry-Based Study with ABMTRR

(UroToday.com) The treatment of germ cell tumors that relapse after or are refractory to platinum-based chemotherapy can include high dose chemotherapy (HDCT) with autologous stem-cell transplant (ASCT). Multiple cohorts from North America and Europe suggest that 5-year overall survival with HDCT ranges is between 48% and 65%. In this abstract, the authors conducted a retrospective and multi-center cohort study of outcomes from HDCT and ASCT in Australia and New Zealand between 1999 and 2019.

ASCO GU 2021: Longer Follow-up Data of Circulating miR371a-3p Expression Across the Spectrum of Germ Cell Tumors

(UroToday.com) In a prior publication, the authors of this abstract published results confirming plasma expression of the microRNA 371a-3p (miR371) can be utilized as a sensitive and specific marker of active germ cell malignancy in patients. In this abstract, Dr. Lucia Nappi and colleagues present updated follow-up data with miR371 expression data to further define the utility of this test in predictive relapse in clinical stage 1 and 2A patients.

ASCO GU 2021: Prediction Model for Brain Metastasis in Patients with Metastatic Germ-Cell Tumors Accounting for Size of Pulmonary Metastases

(UroToday.com) The presence of brain metastases stratifies metastatic germ cell tumors as poor risk and is an independent adverse prognostic factor that can lead to treatment complications and failure. Brain imaging is not necessarily performed for staging imaging unless neurologic symptoms are present. In this abstract, the authors aimed to create a predictive model using certain mGCT patient clinical characteristics to identify patients with high risk of brain metastases.

ASCO GU 2021: Molecular Determinants Associated with Long-Term Response to Apalutamide in Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC)

(UroToday.com) There has been a rapid evolution in treatment options for patients with non-metastatic castration-resistant prostate cancer since the spring of 2018. Up until the presentation of SPARTAN and PROSPER trials, reporting on the use of apalutamide and enzalutamide in non-metastatic castration-resistant prostate cancer, at GU ASCO in February 2018, there were no specifically approved treatment options for these patients. These agents, as well as darolutamide (on the basis of data from ARAMIS), were subsequently approved on the basis of demonstrated improvements in metastasis-free survival. In a plenary abstract presentation in the Oral Abstract Session: Prostate Cancer session at the 2021 ASCO GU Cancers Symposium, Dr. Felix Feng provided an exploratory analysis investigating potential biological signatures of patients with long-term responses.

ASCO GU 2021: The Role of PARP Inhibitors in Prostate Cancer: Is It a Sea Change or Just Another Incremental Change?

(UroToday.com) In a plenary presentation in the Progress and Promise in Treatment Personalization for Advanced Prostate Cancer session at the 2021 ASCO GU Cancers Symposium, Dr. Peter Nelson discussed the role of PARP inhibitors in prostate cancer, highlighting the PARP inhibitor trials, the mechanisms informing biomarkers, questions of precision and accuracy, issues with assay, and potential further opportunities and next steps.

ASCO GU 2021: Role of Definitive Local Therapy After Complete Clinical Response to Neoadjuvant Chemotherapy

(UroToday.com) In a plenary presentation in the Navigating Uncertain Times in Muscle-Invasive and Advanced Bladder Cancer session at the 2021 ASCO GU Cancers Symposium, Dr. Chad Ritch discussed the role of definitive, consolidative therapy following complete response to neoadjuvant chemotherapy.

ASCO GU 2021: The Oral HIF-2 α Inhibitor MK-6482 in Patients with Advanced Clear Cell Renal Cell Carcinoma (RCC): Updated Follow-up of a Phase I/II Study

(UroToday.com) The treatment landscape for first-line therapy among patients with metastatic renal cell carcinoma (mRCC) has changed dramatically over the past 2 years. In 2018, the publication of the CheckMate214 data demonstrated a survival benefit for patients treated with nivolumab and ipilimumab compared with sunitinib in intermediate and poor-risk mRCC, ushering in the immunotherapy era for mRCC. The subsequent publication of the JAVELIN Renal 101, KEYNOTE-426, and CheckMate-9ER studies demonstrated the superiority of avelumab and axitinib, pembrolizumab, and axitinib, and nivolumab and cabozantinib compared to sunitinib in this disease space. However, few patients respond completely and most will progress within the year.

ASCO GU 2021: Optimal Radiologic Assessment After Systemic Therapy for Muscle-Invasive Bladder Cancer

(UroToday.com) In a plenary presentation in the Navigating Uncertain Times in Muscle-Invasive and Advanced Bladder Cancer session at the 2021 ASCO GU Cancers Symposium, Dr. Valeria Panebianco discussed the optimal approach to radiologic assessment following initial systemic therapy for muscle-invasive bladder cancer.

ASCO GU 2021: Phase 3 Trial of Lenvatinib plus Pembrolizumab or Everolimus Versus Sunitinib Monotherapy as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma (CLEAR Study)

(UroToday.com) The treatment landscape for first-line therapy among patients with metastatic renal cell carcinoma (mRCC) has changed dramatically over the past 2 years. In 2018, the publication of the CheckMate214 data demonstrated a survival benefit for patients treated with nivolumab and ipilimumab compared with sunitinib in intermediate and poor-risk mRCC, ushering in the immunotherapy era for mRCC. The subsequent publication of the JAVELIN Renal 101, KEYNOTE-426, and CheckMate-9ER studies demonstrated the superiority of avelumab and axitinib, pembrolizumab, and axitinib, and nivolumab and cabozantinib compared to sunitinib in this disease space. Recently, lenvatinib and everolimus demonstrated prolonged progression-free survival, compared to everolimus, in the second-line setting, and lenvatinib and pembrolizumab have shown promise in a phase I/II setting. In a plenary abstract presentation in the Oral Abstract Session: Renal Cell Cancer session at the 2021 ASCO GU Cancers Symposium, Dr. Robert Motzer and colleagues describe the results of the CLEAR study examining first-line lenvatinib and everolimus or lenvatinib and pembrolizumab versus sunitinib in patients with advanced RCC. Concurrent with the presentation, CLEAR was published in the New England Journal of Medicine.1

ASCO GU 2021: Patient Perspective on Newly Diagnosed Muscle-Invasive Bladder Cancer: What Do I Hope the Doctor Will Address?

(UroToday.com) In a plenary presentation in the Navigating Uncertain Times in Muscle-Invasive and Advanced Bladder Cancer session at the 2021 ASCO GU Cancers Symposium, Mr. Richard Bangs provided the patient perspective for those with new diagnoses of muscle-invasive bladder cancer.

ASCO GU 2021: First Results from the Phase 3 CheckMate 274 Trial of Adjuvant Nivolumab vs Placebo in Patients Who Underwent Radical Surgery for High-Risk Muscle-Invasive Urothelial Carcinoma

(UroToday.com) For patients with muscle-invasive bladder cancer who are eligible for curative-intent treatment, cisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) is a standard of care with improved pathologic response and overall survival (OS) compared to RC alone. Consolidation with chemoradiotherapy (CRT) is an alternative to RC. However, many patients are cisplatin-ineligible and thus often do not receive NAC. In patients who do not receive NAC for whatever reason, there is no conclusive data to support the use of adjuvant therapy. Further, the role of adjuvant chemotherapy is unclear in patients who have residual disease following NAC. In a plenary presentation in the Navigating Uncertain Times in Muscle-Invasive and Advanced Bladder Cancer session at the 2021 ASCO GU Cancers Symposium, Dr. Dean Bajorin presents the results of CheckMate-274 assessing the role of adjuvant nivolumab in patients following radical resection with or without NAC with cisplatin.

ASCO GU 2021: Impact of Equal Access Healthcare on Race Disparities in Bladder Cancer

(UroToday.com) In the United States, there are significant racial disparities in cancer outcomes. In prostate cancer, observed differences in survival between black and white men were essentially eliminated in the equal access Veterans Affairs’ (VA) system. As with prostate cancer, outcomes in bladder cancer are disproportionately worse for black patients compared to white patients. In a plenary abstract presentation in the Rapid Abstract Session: Urothelial Carcinoma and Rare Tumors session at the 2021 ASCO GU Cancers Symposium, Dr. Nikhil Kotha and colleagues examined outcomes by race for patients with bladder cancer within the VA system and then compare these outcomes to those in the Surveillance, Epidemiology, and End Results (SEER) database.