ASCO GU 2022

ASCO GU 2022: First-Line Pembrolizumab with or Without Lenvatinib in Patients with Advanced Urothelial Carcinoma (LEAP-011): A Phase 3, Randomized, Double-Blind Study.

(UroToday.com) On the second day of the American Society for Clinical Oncology (ASCO) Genitourinary Cancer Symposium 2022, Dr. Yohann Loriot presented in a session highlighting novel therapies in bladder cancer and their toxicities, describing the results of the LEAP-011 trial examining first line pembrolizumab with or without Lenvatinib in patients with advanced urothelial cancer (aUC).

ASCO GU 2022: Bladder-Sparing Trimodality Therapy: Toxicity and Functional Outcomes in the Era of Novel Therapeutics

(UroToday.com) On the second day of the American Society for Clinical Oncology (ASCO) Genitourinary Cancer Symposium 2022, Dr. Sophia Kamran presented in a session highlighting novel therapies in bladder cancer and their toxicities, discussing the role of bladder-sparing trimodality therapy with a focus on toxicity and functional outcomes.

ASCO GU 2022: A Path Forward: Addressing Disparities in Genitourinary Cancers

(UroToday.com) On the second day of the American Society for Clinical Oncology (ASCO) Genitourinary Cancer Symposium 2022, Dr. Karen Knudsen, Chief Executive Officer of the American Cancer Society (ACS), presented the keynote lecture focusing on the path forward to address disparities in genitourinary cancers.

ASCO GU 2022: ABLE: Phase 2, Single-Arm, Two-Stage Study of Nab-Paclitaxel with Anti-PD1/PDL1 in Advanced Urothelial Cancer

(UroToday.com) The 2022 GU ASCO Annual meeting included a urothelial carcinoma session highlighting work from Dr. Irene Tsung and colleagues presenting results of ABLE, a phase 2, single-arm, two-stage study of nab-paclitaxel with anti-PD1/PDL1 in advanced urothelial cancer. Anti-PD/PDL1 immune checkpoint inhibitor monotherapy is standard in select PDL1 expressing advanced urothelial cancer and platinum-refractory advanced urothelial cancer. Nab-paclitaxel previously showed encouraging activity in platinum-refractory advanced urothelial cancer. Dr. Tsung and investigators conducted a single-arm trial of the combination of nab-paclitaxel and pembrolizumab in platinum-refractory or cisplatin-ineligible advanced urothelial cancer.

ASCO GU 2022: Biomarker Analysis and Updated Clinical Follow-up from BLASST-1 (Bladder Cancer Signal Seeking Trial) of Nivolumab, Gemcitabine, and Cisplatin in Patients with MIBC Undergoing Cystectomy

(UroToday.com) The 2022 GU ASCO Annual meeting included a urothelial carcinoma session featuring work from Dr. Shilpa Gupta and colleagues presented results from BLASST-1, specifically biomarker analysis and updated clinical follow-up among MIBC patients receiving nivolumab, gemcitabine, and cisplatin. The BLASST-1 study is multi-center phase II trial evaluating the combination of nivolumab with gemcitabine-cisplatin as neoadjuvant therapy for patients with MIBC undergoing radical cystectomy (RC). The primary endpoint was pathologic downstaging (≤pT1N0). Safety, Relapse-free survival (RFS), Progression-free survival (PFS) and biomarker analyses were secondary endpoints. At GU ASCO 2020, the investigators previously reported a pathologic downstaging rate of 65.8% and pathologic complete response (pCR) rate of 49%. There were no safety concerns or delays to surgery. At GU ASCO 2022, Dr. Gupta correlates pathologic downstaging with biomarkers (Tumor mutational burden (TMB), PD-L1, and molecular subtypes) and provides updated clinical follow-up data.

ASCO GU 2022: First-Line Pembrolizumab in Advanced Urothelial Carcinoma: Clinical Parameters Associated with Efficacy in the Phase 2 KEYNOTE-052 and Phase 3 KEYNOTE-361 Trials

(UroToday.com) The 2022 GU ASCO Annual meeting included a urothelial carcinoma session featuring work from Dr. Tibor Csoszi and colleagues presenting results assessing clinical parameters associated with efficacy in the phase 2 KEYNOTE-052 and phase 3 KEYNOTE-361 trials of first-line pembrolizumab in advanced disease. First-line treatment with pembrolizumab monotherapy has shown durable clinical activity in selected patients with advanced/unresectable or metastatic urothelial carcinoma. Cisplatin-ineligible patients with advanced urothelial carcinoma who were not previously treated with chemotherapy were enrolled in KEYNOTE-052,1 and patients with untreated advanced urothelial carcinoma were enrolled in KEYNOTE-361.2 In a pooled population of patients with advanced urothelial carcinoma from the single-arm phase 2 KEYNOTE-052 and the randomized, open-label, phase 3 KEYNOTE-361 studies, this exploratory analysis evaluated the relationship between baseline characteristics and clinical outcomes of first-line pembrolizumab monotherapy. The study designs for these two trials are as follows:

ASCO GU 2022: Impact of Primary Tumor Location on Efficacy and Safety of Pembrolizumab in Patients with Locally Advanced or Metastatic Urothelial Carcinoma Enrolled in the Phase 2 KEYNOTE-052 and Phase 3 KEYNOTE-045 Trials

(UroToday.com) The 2022 GU ASCO Annual meeting included a urothelial carcinoma session featuring work from Dr. Peter O'Donnell and colleagues presenting results assessing the impact of primary tumor location on efficacy and safety of pembrolizumab in patients with locally advanced or metastatic urothelial carcinoma enrolled in the phase 2 KEYNOTE-052 and phase 3 KEYNOTE-045 trials. Pembrolizumab showed antitumor activity in first-line and second line for patients with urothelial carcinoma in the single-arm, phase 2 KEYNOTE-052 study1 and the randomized phase 3 KEYNOTE0452 study, respectively. This post hoc exploratory analysis evaluated whether primary tumor location affected efficacy and safety of pembrolizumab (KEYNOTE052; KEYNOTE-045) and chemotherapy (KEYNOTE-045).

ASCO GU 2022: Futibatinib plus Pembrolizumab in Patients with Advanced or Metastatic Urothelial Carcinoma: Preliminary Safety Results from a Phase 2 Study

(UroToday.com) The 2022 GU ASCO Annual meeting included a urothelial carcinoma session highlighting work from Dr. Vadim Koshkin and colleagues presenting preliminary results of futibatinib plus pembrolizumab in patients with advanced or metastatic urothelial carcinoma.

ASCO GU 2022: Molecular Residual Disease Detection with a Tissue Comprehensive Genomic Profiling-Informed Personalized Monitoring Assay: An Exploratory Analysis of the IMvigor-010 Observation Arm

(UroToday.com) The 2022 GU ASCO Annual meeting included a urothelial carcinoma session highlighting work from Dr. Amanda Young and colleagues presenting results of an exploratory analysis of the IMvigor-010 observation arm assessing molecular residual disease detection with a tissue comprehensive genomic profiling-informed personalized monitoring assay. There is compelling rationale that detection of molecular residual disease following curative therapy may identify patients at high risk of relapse requiring intensified adjuvant therapy. Combining molecular residual disease detection with comprehensive genomic profiling creates an opportunity to offer molecular residual disease-guided treatment with precision cancer therapeutics. At GU ASCO 2022, Dr. Young and investigators analyzed the observation arm of the IMvigor-010 study1 to understand the genomics of resected early stage bladder cancer and to validate comprehensive genomic profiling-informed personalized molecular residual disease detection in circulating tumor DNA (ctDNA).

ASCO GU 2022: Post Hoc Analysis of the Efficacy of Pembrolizumab Retreatment After Progression of Advanced Urothelial Carcinoma in KEYNOTE-045 and KEYNOTE-052

(UroToday.com) The 2022 GU ASCO Annual meeting included a urothelial carcinoma session featuring work from Dr. Daniel Castellano and colleagues presenting the results of a post hoc analysis of the efficacy of pembrolizumab retreatment after progression of advanced urothelial carcinoma in KEYNOTE-045 and KEYNOTE-052. Pembrolizumab has shown efficacy in advanced/unresectable and metastatic urothelial carcinoma. Pembrolizumab showed antitumor activity in first-line and second line for patients with urothelial carcinoma in the single-arm, phase 2 KEYNOTE-052 study [1] and the randomized phase 3 KEYNOTE045 [2] study, respectively. There is interest in determining whether patients should be treated subsequently with checkpoint inhibitors such as anti–PD-1 therapy if metastatic urothelial carcinoma responds then later progresses. Pembrolizumab retreatment after disease progression has shown efficacy in melanoma and NSCLC. This post hoc exploratory analysis investigated the efficacy of pembrolizumab retreatment for patients with advanced urothelial carcinoma or metastatic urothelial carcinoma enrolled in KEYNOTE-045 and KEYNOTE-052 with a best overall response of SD or better and whose disease progressed after discontinuation or completion of 2 years of therapy.

ASCO GU 2022: PD-L1 Expression and BCG Response in Nonmuscle Invasive Bladder Cancer (NMIBC)

(UroToday.com) The 2022 GU ASCO Annual meeting included a urothelial carcinoma session featuring work from Dr. Solomon L. Woldu and colleagues presenting results assessing PD-L1 expression and BCG response in nonmuscle invasive bladder cancer (NMIBC). Intravesical BCG is the standard of care adjuvant therapy for high risk NMIBC, yet many patients experience recurrence or disease progression. The mechanism of action of BCG is believed to be related to the stimulation of immune surveillance. Relatedly, systemic immune checkpoint inhibition is currently being utilized in advanced bladder cancer and approved for BCG unresponsive NMIBC. This study sought to determine the association between PD-L1 expression and BCG treatment.  This study identified 102 BCG-naïve patients with high grade NMIBC treated with BCG. All patients underwent initial transurethral resection (TUR) for pathologic diagnosis. Dako 22c3 assay was used to determine PD-L1 expression. Patients were defined as PD-L1 positive if the combined positive score (CPS) > 0. BCG unresponsiveness was defined by the presence of high grade disease at 6 months following adequate BCG (one induction and maintenance cycle or two induction cycles) for pT1 or 12 months for CIS or presence of pT1 at 3 months following induction. High grade relapse was defined as the presence of any high grade disease after being followed for 6 months after BCG.

ASCO GU 2022: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Toripalimab in Patients with Metastatic Urothelial Carcinoma (POLARIS-03 Study): Two-Year Survival Update and Biomarker Analysis

(UroToday.com) The 2022 GU ASCO Annual meeting included a urothelial carcinoma session highlighting work from Dr. Xinan Sheng and colleagues presenting two-year survival results of the POLARIS-03 study assessing toripalimab in patients with metastatic urothelial carcinoma. Patients with advanced metastatic urothelial carcinoma who experience disease progression after standard therapy have limited treatment options. Toripalimab was approved in China (April 2021) for the 2nd line treatment of metastatic urothelial carcinoma based on a phase II clinical study (POLARIS-03) in Chinese patients with metastatic urothelial carcinoma. At GU ASCO 2022, Dr. Sheng and investigators report the two-year OS update and biomarker analysis of the study.

ASCO GU 2022: Study RC48-C014: Preliminary Results of RC48-ADC Combined with Toripalimab in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

(UroToday.com) The 2022 GU ASCO Annual meeting included a urothelial carcinoma session featuring work from Dr. Li Zhou and colleagues presenting the preliminary results of the RC48-C014 trial assessing RC48-ADC combined with toripalimab in patients with locally advanced or metastatic urothelial carcinoma. RC48-ADC is a novel humanized anti-HER2 antibody-drug conjugate, which showed promising data in HER2-positive and even negative patients with metastatic urothelial carcinoma. In the second line treatment of HER2 overexpressed locally advanced or metastatic urothelial carcinoma, RC48-ADC showed an ORR of 51.2%, PFS of 6.9 months, and OS of 13.9 months. Toripalimab is an anti-PD-1 antibody with a durable antitumor effect for metastatic urothelial carcinoma (ORR of 26%, PFS of 2.3 months, and OS of 14.4 months). The combination may have a synergistic antitumor effect. Initial RC48-C014 data was previously presented at ASCO 2021, and at GU ASCO 2022 Dr. Zhou and investigators report an update on safety and ORR.

ASCO GU 2022: SWOG S1314: A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Localized, MIBC with Overall Survival Follow Up

(UroToday.com) The 2022 GU ASCO Annual meeting included a urothelial carcinoma session featuring work from Dr. Thomas Flaig and colleagues presented results from SWOG S1314, a randomized phase II study of co-expression extrapolation (COXEN) with neoadjuvant chemotherapy for localized, muscle-invasive bladder cancer (MIBC) with overall survival follow up. This trial evaluated COXEN, a gene expression model, as a predictive biomarker in muscle-invasive bladder cancer patients randomized to Gemcitabine-Cisplatin or dose-dense Methotrexate-Vinblastine-Adriamycin/doxorubicin-Cisplatin (ddMVAC). Primary results correlating COXEN with pathologic response at surgery have been reported. This secondary analysis includes progression-free (PFS) and overall survival (OS).

ASCO GU 2022: The Association of FDG PET/CT and NaF PET/CT with Survival Outcomes in Patients with Metastatic Genitourinary Malignancies Treated with Cabozantinib + Nivolumab +/- Ipilimumab

(UroToday.com) The 2022 GU ASCO Annual meeting included a urothelial carcinoma session highlighting work from Dr. Nicholas Simon and colleagues presenting results assessing the association of FDG PET/CT and NaF PET/CT with survival outcomes in patients with metastatic genitourinary malignancies treated with cabozantinib + nivolumab +/- ipilimumab. FDG PET/CT is widely used to assess for tumor burden, and NaF PET/CT is increasingly being used to assess osseous lesions. The aim of this study was to determine the association of functional imaging parameters obtained on FDG PET/CT and NaF PET/CT with OS for patients with metastatic genitourinary malignancies treated on a phase I study with cabozantinib + nivolumab +/- ipilimumab.

ASCO GU 2022: Treatment Outcomes for mCRPC Following Progression on Upfront ADT with Androgen Receptor Pathway Inhibitors for mCSPC

(UroToday.com) The 2022 GU ASCO Annual meeting included a prostate cancer session highlighting work from Dr. Daniel Khalaf and colleagues presenting their results of treatment outcomes for mCRPC following progression on upfront ADT with androgen receptor pathway inhibitors (ARPIs) for mCSPC. Combined ADT and ARPI are associated with improved radiographic progression free survival (rPFS) and overall survival (OS) compared with ADT alone in patients with mCSPC. However, the activity of subsequent therapies such as docetaxel, radium-223, or a second ARPI at the time of progression to mCRPC is not well characterized.

ASCO GU 2022: The TRAP Trial: Targeting Resistant Prostate Cancer, with or without DNA Repair Defects, Using the Combination of Ceralasertib and Olaparib

(UroToday.com) The 2022 GU ASCO Annual meeting included a prostate cancer session highlighting work from Dr. Zachery R. Reichert and colleagues presenting results of the TRAP trial, targeting resistant prostate cancer, with or without DNA repair defects, using the combination of ceralasertib and olaparib. Men with metastatic, castration resistant prostate cancer (mCRPC) harboring DNA repair defects (~20%) achieve a radiographic progression free survival of 7.4 months with PARP inhibitors. Preclinical studies combining PARP inhibitors (olaparib) and DNA damage checkpoint inhibitor (ATR inhibitor, ceralasertib) show synergy, providing the rationale to test this combination in men with mCRPC, including where single agent olaparib has been shown to be active.

ASCO GU 2022: Real-World Health-Related Quality of Life and Caregiver Needs in Patients with mHSPC and mCRPC

(UroToday.com) The 2022 GU ASCO Annual meeting included a prostate cancer session highlighting work from Dr. Mark Boye and colleagues presenting results of their study assessing real-world health-related quality of life (HRQoL) and caregiver needs in patients with metastatic hormone-sensitive (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer is one of the most common cancers in men. When making treatment decisions, patient HRQoL and caregiver needs are important considerations, and as such, it is imperative to understand the impact that prostate cancer has on HRQoL. The aim of this study was to assess the impact of mHSPC and mCRPC on HRQoL and associated caregiver needs.

ASCO GU 2022: Real-World Analyses of Major Adverse Cardiovascular Event Risk by Drug Class After Initiation of ADT

(UroToday.com) The 2022 GU ASCO Annual meeting included a prostate cancer session featuring work from Dr. David Crawford and colleagues presenting results of their real-world analyses of major adverse cardiovascular event (MACE) risk by drug class after initiation of ADT. Recent literature has suggested an association between ADT and increased cardiovascular risk in prostate cancer patients. The 1-year incidence of MACE in patients ≥45 years old was 1.4%, whereas a recent study of prostate cancer patients on ADT reported MACE in 2.9% of patients treated with an LHRH antagonist (relugolix), and 6.2% of patients treated with an LHRH agonist (leuprolide acetate) over 48 weeks in the HERO trial.1 Thus, MACE risk is an important consideration for prostate cancer patients on ADT. This study aims to evaluate MACE risk after ADT initiation with LHRH agonists versus LHRH antagonists using real-world data.

ASCO GU 2022: Real World Treatment Patterns Among Patients with mCRPC in the United States

(UroToday.com) The 2022 GU ASCO Annual meeting included a prostate cancer session highlighting work from Dr. Elisabetta Malangone-Monaco and colleagues presenting results of their study assessing real-world treatment patterns among patients with metastatic castration resistant prostate cancer (mCRPC) in the United States. mCRPC is an incurable disease with a poor prognosis. Though multiple treatments such as novel hormonal therapies (NHT: abiraterone, enzalutamide, docetaxel, cabazitaxel, sipuleucel-T, etc.) are approved, real-world data regarding treatment sequencing are lacking. This study assesses the real-world treatment patterns within the context of FDA-approved life-prolonging treatments for mCRPC.

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