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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...
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...
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...
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, 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, 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, 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).
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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;...
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)....
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...
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...
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...
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, 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).
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....
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...
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...
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, 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.
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...
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...
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, 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, 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).
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...
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.
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, 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).
Daniel M. Geynisman, MD, of Fox Chase Cancer Center, discusses phase II results from the RETAIN BLADDER study, which sequenced bladder tumor samples while treating patients with neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin chemotherapy. The goal was to increase metastasis-free survival and also preserve the bladder and quality of life (Abstract 397).
Treatment with the antibody-drug conjugate enfortumab vedotin-ejfv has been found to significantly increase survival of patients with metastatic urothelial carcinoma, according to results from the phase III EV-301 clinical trial. These findings were presented by Thomas Powles, MD, PhD, and...
Thomas Powles, MD, PhD, of Cancer Research UK Barts Centre, discusses phase III results from the EV-301 trial, which showed that enfortumab vedotin is the first therapy to demonstrate a significant survival advantage over standard chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma (Abstract 393).
Treatment with the immunotherapy nivolumab with or without cisplatin-based chemotherapy following radical surgery significantly improved disease-free survival in patients with muscle-invasive urothelial carcinoma, irrespective of their PD-L1 status, according to a study that will be presented by...
The U.S. Food and Drug Administration (FDA) recently granted Priority Review to nivolumab as either adjuvant or first-line therapy in several types of gastric cancers, as well as to a novel PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal. The FDA also...
As reported in the Journal of Clinical Oncology by Catto et al, the BRAVO-Feasibility study showed that recruitment of patients with high-grade, non–muscle invasive bladder cancer into a randomized trial comparing radical cystectomy vs intravesical bacillus Calmette-Guérin (BCG) proved difficult,...
In a study reported in Nature Communications, Bishoy M. Faltas, MD, of the Department of Medicine, Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York, and colleagues identified common germline-somatic variant interactions in advanced urothelial cancer, with these...
In a study reported in Nature Communications, Vosoughi et al identified common germline-somatic variant interactions in advanced urothelial cancer, with these interactions appearing to play a central role in disease progression. As stated by the investigators, “The prevalence and the biologic...
Patients with muscle-invasive urothelial cancer and postsurgical circulating tumor DNA (ctDNA) positivity have high risk of disease recurrence following cystectomy and experienced improved clinical outcomes with adjuvant atezolizumab as compared to patients undergoing observation. These...
As reported in The Lancet Oncology by Thomas Powles, MD, of Barts Cancer Institute, Queen Mary University of London, and colleagues, the phase III DANUBE trial showed that durvalumab monotherapy did not prolong overall survival vs standard chemotherapy in previously untreated patients with...
Formal discussant Kilian M. Gust, MD, of the Medical University of Austria, Vienna, reminded listeners that JAVELIN Bladder 100 was designed at a time when no checkpoint inhibitor was approved for the treatment of metastatic urothelial cancer. In the past 5 years, five immune checkpoint inhibitors...
A strategy of front-line maintenance treatment with the PD-L1 inhibitor avelumab combined with best supportive care improved both progression-free and overall survival vs best supportive care alone across prespecified subgroups of patients with advanced or metastatic urothelial carcinoma that had...
In his discussion of KEYNOTE-361 and the DANUBE trial, Richard Cathomas, MD, of Kantonsspital, Graubünden, Switzerland, said both studies yielded disappointing results. Overall, in these trials as well as current evidence from other trials, treatment of platinum-eligible (cisplatin or carboplatin)...