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ASCO GU 2021

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

(UroToday.com) Metastatic castration-resistant prostate cancer (mCRPC) remains a lethal disease despite the increased number of treatment options that have been Federal Drug Administration (FDA) approved in the past decade. Most recently, the PARP inhibitors olaparib and rucaparib were approved for men with mCRPC harboring certain gene alterations associated with homologous recombination deficiency. In this study, Dr. Rana McKay presented a phase 2 study of olaparib versus olaparib in combination with the 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.

ASCO GU 2021: A Prospective Phase II/III Study of PSMA-Targeted 18F-DCFPyL-PET/CT in Patients with Prostate Cancer (PCa) (OSPREY): A Subanalysis of Disease Staging Changes in PCa Patients with Recurrence or Metastases on Conventional Imaging

(UroToday.com) Conventional imaging modalities including computed tomography and bone scintigraphy are routinely recommended for prostate cancer staging, however, they are limited by relatively low sensitivity and moderate specificity. In contrast, PSMA-based imaging is highly promising for prostate cancer detection, with higher sensitivity, specificity, and accuracy. 18F-DCFPyL is a novel PSMA-targeted radiopharmaceutical for positron emission tomography (PET) being explored in the staging of prostate cancer. Previously, at AUA 2020, the diagnostic performance, detection rate, and potential impact of 18F-DCFPyL on the staging of patients with high- risk prostate cancer was reported. In a plenary abstract presentation in the Poster Highlights Session: Prostate Cancer session at the 2021 ASCO GU Cancers Symposium, Dr. Jeremy Durack and colleagues report on the impact of 18F-DCFPyL on the staging of patients with prostate cancer recurrence or metastases on conventional imaging.

ASCO GU 2021: Avelumab First-Line Maintenance plus Best Supportive Care (BSC) Versus BSC Alone for Advanced Urothelial Carcinoma: JAVELIN Bladder 100 Japanese Subgroup Analysis

(UroToday.com) Advanced urothelial carcinoma has among the worst prognosis for tumors treated by genitourinary oncologists. Standard of care dictates that patients receive platinum-based induction chemotherapy. However, even with this treatment, rates of recurrence and disease progression are high and overall survival is quite short due to the development of chemotherapy resistance. In the JAVELIN Bladder 100 study which was reported at ASCO 2020 Annual Meeting, the addition of avelumab, a PD-L1 directed therapy, as first-line maintenance to best supportive care demonstrated improvements in overall survival for patients who did not have disease progression during their initial cytotoxic chemotherapy induction.

ASCO GU 2021: Cabazitaxel Multiple Rechallenge in Metastatic Castration-Resistant Prostate Cancer: A Therapeutic Option to Increase Overall Survival?

(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. However, many patients will exhaust efficacious treatment options. Cabazitaxel is typically used in the second-line chemotherapy setting. In a plenary abstract presentation in the Poster Highlights Session: Prostate Cancer session at the 2021 ASCO Genitourinary Cancers Symposium (ASCO GU), Dr. Pobel and colleagues assess the feasibility and efficacy of cabazitaxel multiple rechallenges in patients with mCRPC.

ASCO GU 2021: Genomic Characterization of Bladder Cancer with Variant Histology

(UroToday.com) While the preponderance of patients with bladder tumors have urothelial histology, up to 25% of tumors are of pure variant or mixed urothelial and variant histology. These variant histologies are associated with more advanced stage at presentation and worse response to systemic therapy. In a poster presentation at the 2021 ASCO GU Cancers Symposium, Dr. Andrew Lenis and colleagues presented a genomic analysis of bladder cancers with variant histology.

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

(UroToday.com) The SPARTAN clinical trial was a randomized phase 3 placebo-controlled patients evaluating the efficacy of the Androgen Receptor antagonist apalutamide in combination with androgen deprivation therapy (ADT) in patients with nonmetastatic castration resistant prostate cancer (nmCRPC) whose PSA doubling time was less than 12 months. The schema of the study is shown below. Patients were randomized 2:1 to either apalutamide or placebo in combination with ADT. The primary outcome of the study was metastasis free survival (MFS), which is a surrogate for overall survival. Secondary and exploratory outcomes of the study are shown below.

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) Metastatic castration resistant prostate cancer (mCRPC) continues to be driven by androgen signaling, but this patient population has heterogeneous responses to second-generation androgen pathway inhibitors. Apalutamide, an androgen receptor antagonist, and abiraterone acetate, and androgen synthesis inhibitor, have somewhat distinct mechanisms of action and efficacy in mCRPC. The ACIS trial (NCT02257736) was designed to study is the combination of these two therapies, termed androgen annihilation, as first-line therapy in mCRPC.

ASCO GU 2021: Survival Outcomes in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC): A Real-World Evidence Study

(UroToday.com) The field of advanced prostate cancer has rapidly progressed over the past 15 years. In the past 5 years, there has been considerable development in the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC), including chemotherapy and novel hormonal therapies (NHT). Each of these has proven survival benefits compared to the historic standard of androgen deprivation therapy (ADT) alone. However, the uptake of these guideline-recommended treatment approaches with level 1 data is unknown. In a plenary abstract presentation in the Poster Highlights Session: Prostate Cancer session at the 2021 ASCO GU Cancers Symposium, Dr. Stephen Freedland and colleagues assessed utilization and outcomes for patients with mCSPC in the Veterans Health Administration system.

ASCO GU 2021: PARP Inhibitors – Is It A Sea Change or Just Another Incremental Change?

(UroToday.com) In this presentation at the 2021 ASCO Genitourinary Cancers Symposium (ASCO GU) Dr. Peter Nelson discussed the evidence leading to the approval of the PARP inhibitors olaparib and rucaparib in advanced prostate cancer and then discussed issues surrounding biomarkers for patient selection. 

ASCO GU 2021: 177Lu-PSMA-617 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) Targeting the PSMA protein is one of the most promising emerging approaches to treating advanced prostate cancer.  PSMA, the Prostate Specific Membrane Antigen, is expressed predominantly on prostate cells, as well as to a lesser degree in proximal tubules of the kidney, the small intestine, and oromaxillary glands.  As expression is further increased with prostate carcinogenesis, targeting of PSMA has been increasingly enticing.  Several approaches including small molecule- and antibody-based technologies1,2 have emerged carrying a “payload” of chemo- or radiotherapy or engineered to bring immune effector cells in close proximity to prostate cancer cells.  Last year, the authors (Dr. Hofman et al.) presented the results of the randomized phase II study, TheraP, which compared 177Lu-PSMA-617 to cabazitaxel in the treatment of post-docetaxel metastatic castration resistant prostate cancer (mCRPC).1  There, the small molecule 617 was conjugated to a beta-emitting radionuclide (177Lu) and they reported improved activity (via PSA50), improved PSA-PFS, and fewer Grade 3 or 4 adverse events, as compared to cabazitaxel therapy.
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