Nivolumab for Adjuvant Treatment of Urothelial Carcinoma
On August 19, 2021, the PD-1 inhibitor nivolumab was approved for adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection.1 This is the first approval by the U.S. Food and Drug Administration for adjuvant treatment of patients...
DD-MVAC vs Gemcitabine/Cisplatin for Muscle-Invasive Bladder Cancer
The randomized phase III controlled GETUG/AFU VESPER V05 trial was designed to compare the efficacy of two perioperative treatment regimens—gemcitabine/cisplatin or dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC)—in patients with muscle-invasive bladder cancer. The...
Radical Cystectomy: Early-Stage Micropapillary Bladder Cancer Outcomes Similar to Late-Stage Conventional Urothelial Carcinoma
A study presented by Kevin Ginsburg, MD, and colleagues at the American Urological Association 2021 Annual Meeting has found that among patients treated with radical cystectomy, those with cT1 micropapillary bladder cancer had similar or worse oncologic outcomes compared with patients with cT2...
Enfortumab Vedotin-ejfv in Urothelial Cancer
On July 9, 2021, enfortumab vedotin-ejfv, an antibody-drug conjugate targeting nectin-4, was granted regular approval. The agent is indicated for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and platinum chemotherapy or...
Neoadjuvant Gemcitabine and Split-Dose Cisplatin Plus Pembrolizumab for Muscle-Invasive Bladder Cancer
In a phase II study reported in the Journal of Clinical Oncology, Tracy L. Rose, MD, MPH, and colleagues found that neoadjuvant therapy with pembrolizumab, gemcitabine, and primarily split-dose cisplatin resulted in pathologic downstaging (< pT2N0) in more than half of patients undergoing...
FDA Revises Label for Pembrolizumab in Patients With Advanced Urothelial Carcinoma
On August 31, the U.S. Food and Drug Administration (FDA) revised the label for the anti–PD-1 therapy pembrolizumab for its indication in first-line advanced urothelial carcinoma. The FDA converted the indication from an accelerated approval to a full approval. In addition, as part of the label...
Addition of ATR Inhibitor Berzosertib to Cisplatin/Gemcitabine in Metastatic Urothelial Carcinoma
In a phase II trial reported in JAMA Oncology, Sumanta K. Pal, MD, FASCO, and colleagues found that the addition of the ATR inhibitor berzosertib to cisplatin/gemcitabine provided no benefit in patients with metastatic urothelial carcinoma. The triplet did not prolong progression-free survival, and ...
Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Urothelial Cancer
On April 13, 2021, sacituzumab govitecan-hziy was granted accelerated approval to treat patients with locally advanced or metastatic urothelial cancer who had received platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor.1 Supporting Efficacy Data Approval was based on findings...
FDA Approves Nivolumab for Adjuvant Treatment of Urothelial Carcinoma
On August 19, the U.S. Food and Drug Administration (FDA) approved the anti–PD-1 therapy nivolumab (Opdivo) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of disease recurrence after undergoing radical resection. This is the first FDA approval for adjuvant...
Adjuvant Nivolumab Improves Disease-Free Survival in High-Risk Muscle-Invasive Urothelial Carcinoma
As reported in The New England Journal of Medicine by Dean F. Bajorin, MD, of the Department of Medicine, Memorial Sloan Kettering Cancer Center, and colleagues, an interim analysis of the phase III CheckMate 274 trial has shown improved disease-free survival with adjuvant nivolumab vs placebo...
Is Disease-Free Survival the Best Endpoint for Adjuvant Nivolumab in High-Risk, Muscle-Invasive Urothelial Carcinoma?
The role of adjuvant treatment for invasive, high-grade bladder cancer remains controversial and challenging. Sternberg et al reported a statistically significant progression-free survival benefit from adjuvant combination gemcitabine/cisplatin (GC) or MVAC (methotrexate, vinblastine, doxorubicin, ...
Adjuvant Nivolumab Improves Disease-Free Survival in High-Risk Muscle-Invasive Urothelial Carcinoma
As reported inThe New England Journal of Medicine by Dean F. Bajorin, MD, of the Department of Medicine, Memorial Sloan Kettering Cancer Center, and colleagues, an interim analysis of the phase III CheckMate 274 trial has shown improved disease-free survival with adjuvant nivolumab vs placebo...
Sacituzumab Govitecan-hziy: Welcome Addition to Advanced Urothelial Cancer Treatments, but Time to Figure Out Sequencing and Combinations
The results of Cohort 1 of the phase II trial TROPHY-U-01 (IMMU-132-06; ClinicalTrials.gov identifier NCT03547973), published in the Journal of Clinical Oncology by Tagawa et al and reviewed in this issue of The ASCO Post, led to the recent accelerated U.S. Food and Drug Administration (FDA)...
Sacituzumab Govitecan-hziy in Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy
In a cohort of the phase II TROPHY-U-01 trial reported in the Journal of Clinical Oncology, Scott T. Tagawa, MD, MS, of Weill Cornell Medicine, New York, and colleagues, found that the antibody-drug conjugate sacituzumab govitecan-hziy produced durable responses in patients with metastatic...
EV-301 Trial: Enfortumab Vedotin-ejfv Improves Overall Survival vs Chemotherapy in Previously Treated Advanced Urothelial Carcinoma
As reported in The New England Journal of Medicine by Thomas Powles, MD, of Barts Cancer Centre, Queen Mary University of London, and colleagues, a prespecified interim analysis of the phase III EV-301 trial has shown improved overall survival with the antibody-drug conjugate enfortumab...
Enfortumab Vedotin-ejfv Granted Regular Approval in Treatment of Locally Advanced or Metastatic Urothelial Cancer
On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv (Padcev), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and...
Study Finds Patients With Bladder Cancer and Ureteric Obstruction May Safely Receive Chemotherapy
A study published by Strother et al in BJU International found that patients with muscle-invasive bladder cancer can safely receive cisplatin-based neoadjuvant chemotherapy, even when their tumors are blocking their kidneys. The findings suggest that patients with the most serious type of this...
Peter H. O’Donnell, MD, on Urothelial Cancer: First-Line Pembrolizumab in Cisplatin-Ineligible Patients
Peter H. O’Donnell, MD, of The University of Chicago, discusses response and survival results from the phase II KEYNOTE-052 study, which showed that after up to 5 years of follow-up, pembrolizumab continued to elicit clinically meaningful, durable antitumor activity in cisplatin-ineligible patients with advanced urothelial cancer (Abstract 4508).
Matt D. Galsky, MD, on Bladder Cancer: Neoadjuvant Therapy With Gemcitabine, Cisplatin, and Nivolumab
Matt D. Galsky, MD, of the Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai, discusses results from a phase II trial designed to test gemcitabine and cisplatin plus nivolumab as neoadjuvant therapy in patients with muscle-invasive bladder cancer and to better predict benefit in those who opted out of cystectomy (Abstract 4503).
Sumanta K. Pal, MD, on Urothelial Carcinoma: Comparing Cisplatin and Gemcitabine With or Without Berzosertib
Sumanta K. Pal, MD, of City of Hope, discusses results from a phase II study that sought to determine whether adding berzosertib, a selective ATR inhibitor, to the standard upfront chemotherapy regimen of cisplatin with gemcitabine may improve outcomes in patients with metastatic urothelial carcinoma (Abstract 4507).
KEYNOTE-361: First-Line Pembrolizumab With or Without Chemotherapy vs Chemotherapy Alone in Advanced Urothelial Carcinoma
As reported in The Lancet Oncology by Thomas Powles, MD, PhD, and colleagues, the phase III KEYNOTE-361 trial has shown no significant improvement in progression-free or overall survival with first-line pembrolizumab plus platinum-based chemotherapy vs chemotherapy alone in patients with advanced...
Inclusion of Patients With Brain Metastases in Phase III Trials in Advanced Breast Cancer, Lung Cancer, and Melanoma
In a study reported in a research letter in JAMA Oncology, Corbett et al found that the majority of phase III trials investigating systemic therapy in patients with advanced lung cancer, breast cancer, and melanoma over the past 20 years have excluded or restricted enrollment of those with brain...
CheckMate 274: Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma
As reported in The New England Journal of Medicine by Dean F. Bajorin, MD, and colleagues, an interim analysis of the phase III CheckMate 274 trial has shown improved disease-free survival with adjuvant nivolumab vs placebo among all patients with high-risk muscle-invasive urothelial carcinoma who...
Choice of First-Line Platinum Chemotherapy Does Not Significantly Impact Efficacy of Second-Line Immunotherapy in Advanced Urothelial Carcinoma
In a presentation of real-world data given during the 2021 ASCO Annual Meeting, Miron et al concluded that the choice of first-line platinum chemotherapy did not result in a significant difference in overall survival benefit among patients with advanced bladder cancer who were able to go on to...
Pembrolizumab in BCG-Unresponsive High-Risk Non–Muscle Invasive Bladder Cancer: KEYNOTE-057
As reported in The Lancet Oncology by Arjun V. Balar, MD, and colleagues, the phase II KEYNOTE-057 trial showed that pembrolizumab produced enduring responses in a cohort of patients with high-risk non–muscle invasive bladder cancer unresponsive to bacillus Calmette-Guérin (BCG) who were ineligible ...
Does the Addition of Bevacizumab to Gemcitabine/Cisplatin for Metastatic Urothelial Carcinoma Improve Survival?
As reported in the Journal of Clinical Oncology by Jonathan E. Rosenberg, MD, and colleagues, the phase III CALGB 90601/Alliance trial has shown no improvement in overall survival with the addition of bevacizumab to gemcitabine/cisplatin in patients with metastatic urothelial carcinoma. Study...
FDA ODAC Meeting Focuses on ‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies
In a perspective in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie, approvals for...
Enfortumab Vedotin-ejfv After PD-1 or PD-L1 Inhibitor Therapy for Cisplatin-Ineligible Patients With Advanced Urothelial Carcinoma
As reported in The Lancet Oncology by Evan Y. Yu, MD, and colleagues, findings in a cohort of the phase II EV-201 study showed a high response rate with the nectin-4–directed antibody-drug conjugate enfortumab vedotin-ejfv in cisplatin-ineligible patients with advanced or metastatic urothelial...
Sacituzumab Govitecan-hziy for Patients With Pretreated Metastatic Urothelial Carcinoma
In a cohort of the phase II TROPHY-U-01 trial reported in the Journal of Clinical Oncology, Scott T. Tagawa, MD, MS, and colleagues found that the antibody-drug conjugate sacituzumab govitecan-hziy produced responses in patients with metastatic urothelial carcinoma progressing after platinum-based...
Oncologists Launch Global Society to Improve Clinical Research, Standardize Treatment, and Improve Patient Education About Rare Genitourinary Tumors
Late this past year, a group of oncologists led by Philippe E. Spiess, MD, MS, FRCS(C), FACS, Assistant Chief of Surgical Services and Senior Member in the Department of Genitourinary Oncology at Moffitt Cancer Center and Professor in the Department of Urology at the University of South Florida;...
FDA Pipeline: Priority Reviews of Treatments for Bladder and Lung Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review designation to treatments for surgically resected, high-risk, muscle-invasive urothelial carcinoma and epidermal growth factor receptor exon 20 insertion mutation–positive metastatic non–small cell lung cancer (NSCLC)....
FDA ODAC Votes in Favor of Retaining Accelerated Approval for Bladder Cancer Treatments
Roche has announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favor of maintaining the accelerated approval of atezolizumab for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for...
YouTube Videos on Bladder Cancer: Study Focuses on Quality of Content
Social media platforms are valuable tools for educating patients about serious health topics, but they can also spread false and biased information with potentially harmful results, according to recent research published by Stacy Loeb, MD, MSc, and colleagues in European Urology. Researchers...
Genitourinary Oncology Highlights 2020–2021 Almanac
Landmark changes in the treatment of genitourinary cancers have occurred over the past year, as summarized in this year’s Genitourinary Oncology Almanac from The ASCO Post. Starting with our area of focus, metastatic renal cell carcinoma, the saga continues with two more positive phase III trials...
FDA Pipeline: Recent Designations in Urothelial Cancer, Cervical Cancer, Cholangiocarcinoma, and More
Recently, the U.S. Food and Drug Administration (FDA) issued regulatory decisions related to treatments for urothelial cancer, cervical cancer, cholangiocarcinoma, solid tumors, and colorectal cancer. Acceptance of Two Supplemental Biologics License Applications for Enfortumab Vedotin-ejfv in...
Enrique Grande, MD, PhD, on Urothelial Carcinoma: Treatment With Atezolizumab, Platinum, and Gemcitabine
Enrique Grande, MD, PhD, of The University of Texas MD Anderson Cancer Center, Madrid, discusses phase III overall survival results from the IMvigor130 study of atezolizumab plus platinum and gemcitabine vs placebo plus platinum and gemcitabine in patients with previously untreated metastatic urothelial carcinoma (Abstract CT187).
FDA Grants Accelerated Approval to Sacituzumab Govitecan-hziy for Advanced Urothelial Cancer
On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy (Trodelvy) for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor....
EV-301 and EV-201 Trials: Enfortumab Vedotin-ejfv Improves Survival in Metastatic Urothelial Cancer
Enfortumab vedotin-ejfv continues to move the needle forward as a validated treatment option for advanced urothelial carcinoma. At the 2021 Genitourinary Cancers Symposium, results from the phase III EV-301 study1 and EV-201 Cohort 22 provided support for the use of this agent in both patients...
Adjuvant Atezolizumab in Muscle-Invasive Urothelial Carcinoma: IMvigor010
As reported in The Lancet Oncology by Joaquim Bellmunt, MD, PhD, and colleagues, the phase III IMvigor010 trial showed no improvement in disease-free survival with adjuvant atezolizumab vs observation in patients with muscle-invasive urothelial carcinoma. Study Details In the open-label trial, 809...
Nivolumab: First Adjuvant Immunotherapy to Show Survival Benefit in High-Risk Muscle-Invasive Urothelial Cancer
Adjuvant therapy with nivolumab, an anti–PD-1 immune checkpoint inhibitor, after radical surgery improved disease-free survival in high-risk muscle-invasive urothelial cancer regardless of PD-L1 status, according to the results of the CheckMate 274 randomized phase III trial presented at the 2021...
Arlene O. Siefker-Radtke, MD, on Urothelial Bladder Cancer: New Settings for Immune Checkpoint Inhibitors
Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, discusses the changing therapeutic landscape in which atezolizumab, avelumab, and pembrolizumab have either been approved or are under review for treating urothelial bladder cancer in the metastatic, superficial, and adjuvant settings.
FDA Oncologic Drugs Advisory Committee to Review Status of Six Indications Granted Accelerated Approval
Recently, the U.S. Food and Drug Administration (FDA) announced that the agency will hold a public meeting of the Oncologic Drugs Advisory Committee on April 27 to 29 to discuss six indications granted accelerated approval that have since reported results from confirmatory trials that have not...
Atezolizumab’s Indication in Previously Treated Metastatic Bladder Cancer Is Withdrawn
Genentech, a member of the Roche Group, announced on March 8 that the company is voluntarily withdrawing the U.S. indication for atezolizumab (Tecentriq) in patients with prior platinum-treated metastatic urothelial carcinoma. This decision was made in consultation with the U.S. Food and Drug...
Enfortumab Vedotin-ejfv in Previously Treated Advanced Urothelial Carcinoma
As reported in The New England Journal of Medicine by Powles et al, a prespecified interim analysis of the phase III EV-301 trial has shown improved overall survival with enfortumab vedotin-ejfv vs investigator choice of chemotherapy in patients with previously treated advanced urothelial...
Tracy L. Rose, MD, on Bladder Cancer: Gemcitabine, Cisplatin, and Pembrolizumab as Neoadjuvant Therapy
Tracy L. Rose, MD, of the University of North Carolina at Chapel Hill, discusses phase II results of gemcitabine and split-dose cisplatin plus pembrolizumab as neoadjuvant therapy prior to radical cystectomy for patients with muscle-invasive bladder cancer. The trial showed this combination treatment is generally safe and may improve pathologic downstaging, but further study is warranted (Abstract 396).
Elizabeth R. Plimack, MD, on Bladder Cancer Highlights From the 2021 Genitourinary Cancers Symposium
Elizabeth R. Plimack, MD, of Fox Chase Cancer Center, discusses key abstracts discussed at this year’s meeting on bladder cancer and offers her views on the latest trends and findings (Abstracts 391, 393, 434).
Hypofractionated vs Conventionally Fractionated Radiotherapy for Locally Advanced Bladder Cancer
In an individual patient-level meta-analysis of two phase III trials reported in The Lancet Oncology, Choudhury et al found that a hypofractionated radiotherapy regimen was associated with improved invasive locoregional control and similar toxicity vs a standard fractionation regimen in patients...
Christopher Sweeney, MBBS, and Thomas Powles, MD, PhD, on Treating GU Malignancies: Expert Views
A spirited discussion ensued when we asked Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, and Thomas Powles, MD, PhD, of Cancer Research UK Barts Centre, to compare notes on how they treat bladder, prostate, and kidney cancers.
FDA Pipeline: Priority Reviews in KRAS G12C–Mutated NSCLC, Non–Muscle-Invasive Bladder Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for KRAS G12C–mutated non–small cell lung cancer (NSCLC) and high-risk, bacillus Calmette-Guérin–unresponsive non–muscle-invasive bladder cancer. A new drug application for a therapy for Waldenström’s...
Monika Joshi, MD, on Urothelial Cancer of the Bladder: Durvalumab and Radiotherapy for Localized Disease
Monika Joshi, MD, of Penn State Hershey Cancer Institute, discusses phase II results from the DUART study, which explored the efficacy of concurrent durvalumab, a checkpoint inhibitor, and radiation therapy followed by adjuvant durvalumab in patients with localized urothelial cancer of the bladder (Abstract 398).
