Matthew D. Galsky, MD, FASCO, on Muscle-Invasive Bladder Cancer: Enfortumab Vedotin and Pembrolizumab
Matthew D. Galsky, MD, FASCO, of Mount Sinai Tisch Cancer Center, discusses findings from the randomized phase III KEYNOTE-B15/EV-304 study, which is evaluating neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab followed by radical cystectomy plus pelvic lymph node dissection vs neoadjuvant chemotherapy followed by radical cystectomy plus pelvic lymph node dissection in patients with muscle-invasive bladder cancer who are eligible for cisplatin-based therapy (Abstract LBA630).
Thomas Powles, MD, PhD, FCRP, on a Novel Antibody-Drug Conjugate in Previously Treated Advanced Urothelial Cancer
Thomas Powles, MD, PhD, FCRP, of Barts Cancer Centre, Queen Mary University of London, shares findings from the phase II RC48G001 trial of disitamab vedotin, an antibody-drug conjugate comprising a novel anti-HER2 antibody, disitamab, and an MMAE payload. The agent demonstrated “promising antitumor activity and a manageable safety profile, consistent with results from China, supporting further evaluation,” concluded investigators (Abstract LBA631).
Perioperative Enfortumab Vedotin Plus Pembrolizumab in Cisplatin-Ineligible Bladder Cancer
As reported in The New England Journal of Medicine by Vulsteke et al, the phase III KEYNOTE-905/EV-303 trial has shown improved event-free and overall survival with the addition of perioperative enfortumab vedotin plus pembrolizumab to radical cystectomy in patients with muscle-invasive bladder...
Combined Tests Could Avoid Unnecessary Cystectomy, Study Finds
Combining a visual inspection of the bladder—systematic endoscopic evaluation—with a blood test to check for the presence of circulating tumor DNA (ctDNA) may accurately predict which patients with bladder cancer still have cancer in their bladder after treatment and which do not. These findings,...
Can ctDNA Negativity Predict Metastasis-Free Survival in Muscle-Invasive Bladder Cancer?
Circulating tumor DNA (ctDNA) may be used to predict metastatic risk and identify which patients with muscle-invasive bladder cancer are more likely to benefit from a bladder-sparing treatment approach, according to findings from the RETAIN trials presented at the 2026 ASCO Genitourinary Cancers...
Perioperative Enfortumab Vedotin Plus Pembrolizumab May Reduce Risk of Recurrence in Patients With Muscle-Invasive Bladder Cancer
The results from the randomized phase III KEYNOTE-B15/EV-304 study show that neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab significantly improved event-free survival, overall survival, and pathologic complete response rate in patients with muscle-invasive bladder cancer who were...
Intravesical Immunotherapy Shows Recurrence Control in BCG-Unresponsive Papillary-Only Non–Muscle-Invasive Bladder Cancer
Intravesical treatment with the investigational immunotherapy cretostimogene grenadenorepvec (CG0070) demonstrated “strong” high-grade recurrence-free survival rates in patients with high-risk, papillary-only, bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer, according ...
Can a New Testing Method Allow More Patients With Bladder Cancer to Avoid Radical Cystectomy?
Researchers have reported findings that may help redefine treatment for patients with muscle-invasive bladder cancer, a potentially aggressive form of the disease that is traditionally treated with surgical removal of the bladder. The study, published by Matthew D. Galsky, MD, and colleagues in the ...
Can Color Vision Deficiency Impact Survival in Bladder or Colorectal Cancer?
Color vision deficiency is an inherited condition affecting 1 in 12 males (8%) and 1 in 200 females (0.5%), most often impairing the ability to distinguish the color red. A recent study published in Nature Health examined the possible impact of color vision deficiency on survival outcomes among...
Researchers Advance Understanding of Female Sexual Anatomy to Improve Pelvic Cancer Radiotherapy
A recent, innovative study provides radiation oncologists with practical guidance to identify and protect female sexual organs during pelvic cancer treatment. Published by Greenwald et al in Practical Radiation Oncology, the report’s authors address a long-standing gap in cancer care by bringing...
Addition of Cetrelimab to Erdafitinib in Metastatic Urothelial Carcinoma With FGFR Alterations
In a phase II study (NORSE) reported in the Journal of Clinical Oncology, Loriot et al found that both erdafitinib monotherapy and the combination of erdafitinib and cetrelimab were active as first-line treatment in cisplatin-ineligible patients with metastatic urothelial carcinoma with FGFR...
Can KDM6A Mutations Help Guide Treatment Selection in Bladder Cancer?
Mutations in KDM6A have been identified as a regulator of therapeutic responses in advanced bladder cancer, sensitizing tumors to anti–PD-1 immune checkpoint inhibition but resisting cisplatin chemotherapy, according to early research published in Nature Communications. Based on this and further...
IMvigor011 Subgroup Analysis: Role of ctDNA in Guiding Adjuvant Treatment for Muscle-Invasive Bladder Cancer
Circulating tumor DNA (ctDNA) status after radical cystectomy may be able to effectively guide adjuvant treatment decisions for patients with muscle-invasive bladder cancer, according to data presented at the 26th Annual Meeting of the Society of Urologic Oncology (SUO).1 Results of an exploratory...
Intravesical Cretostimogene Grenadenorepvec Shows Strong High-Grade Recurrence-Free Survival in BCG-Unresponsive Papillary-Only Non–Muscle-Invasive Bladder Cancer
Intravesical cretostimogene grenadenorepvec (CG0070) monotherapy demonstrated strong high-grade recurrence-free survival rates in patients with high-risk, papillary-only, bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer, according to data presented at the 26th Annual...
Gemcitabine Intravesical System Shows High Disease-Free Survival Rates in BCG-Unresponsive Papillary-Only NMIBC
Monotherapy with a gemcitabine intravesical system (TAR-200; Gem-iDRS) demonstrated high disease-free survival rates in patients with bacillus Calmette-Guérin (BCG)-unresponsive papillary-only high-risk non–muscle-invasive bladder cancer (NMIBC), according to data presented at the 26th Annual...
Intravesical Oncolytic Adenovirus Delivers High Complete Response Rates in BCG-Naive, High-Risk, Non–Muscle-Invasive Bladder Cancer With Carcinoma in Situ
Intravesical cretostimogene grenadenorepvec (CG0070) monotherapy demonstrated a high overall complete response rate in patients with high-risk, bacillus Calmette-Guérin (BCG)-naive non–muscle-invasive bladder cancer with carcinoma in situ, according to early results from Cohort A of the phase II...
KEYNOTE-905: Perioperative Immunotherapy Regimen Active in Cisplatin-Ineligible MIBC
A perioperative regimen of the antibody-drug conjugate enfortumab vedotin-ejfv plus the PD-1 inhibitor pembrolizumab significantly improved event-free survival, overall survival, and pathologic complete response rates compared to radical cystectomy alone in patients with muscle-invasive bladder...
Final Analysis Supports Use of Durvalumab Plus BCG Infusions in High-Risk Non–Muscle-Invasive Bladder Cancer
In patients with high-risk non–muscle-invasive bladder cancer, the addition of 1 year of the PD-L1 inhibitor durvalumab to standard induction and maintenance bacillus Calmette-Guérin (BCG) infusions led to a statistically significant and clinically meaningful improvement in disease-free survival...
Upfront Reduced-Dose Enfortumab Vedotin With Pembrolizumab in First-Line Treatment of Advanced Urothelial Cancer
In a U.S. retrospective cohort study reported in JAMA Oncology, Chow et al found that reduced-dose vs standard upfront enfortumab vedotin-ejfv plus pembrolizumab reduced the risk of enfortumab vedotin treatment interruption in the first-line treatment of patients with advanced urothelial cancer....
Final Analysis Supports Use of Durvalumab Plus BCG Infusions in High-Risk Non–Muscle-Invasive Bladder Cancer
In patients with high-risk non–muscle-invasive bladder cancer, the addition of 1 year of the PD-L1 inhibitor durvalumab to standard induction and maintenance bacillus Calmette-Guérin (BCG) infusions led to a statistically significant and clinically meaningful improvement in disease-free survival...
FDA Approves Pembrolizumab With Enfortumab Vedotin-ejfv for Muscle-Invasive Bladder Cancer
On November 21, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) or the subcutaneous formulation pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) in combination with enfortumab vedotin-ejfv (Padcev) as neoadjuvant treatment followed by adjuvant treatment...
Perioperative Immunotherapy Regimen Improves Outcomes in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
A perioperative regimen of the antibody-drug conjugate enfortumab vedotin-ejfv plus the PD-1 inhibitor pembrolizumab significantly improved outcomes vs radical cystectomy alone in patients with muscle-invasive bladder cancer who were ineligible for or declined cisplatin-based chemotherapy. Results...
Addition of Durvalumab to BCG After TURBT for BCG-Naive, High-Risk NMIBC
In the final analysis of the phase III POTOMAC trial reported in The Lancet, De Santis et al found that the addition of durvalumab to bacillus Calmette-Guérin (BCG) induction and maintenance improved disease-free survival in patients with high-risk non–muscle-invasive bladder cancer (NMIBC) who...
Does Kidney Stone History Impact Survival Outcomes in Upper Tract Urothelial Carcinoma?
Based on the results of a multicenter retrospective cohort study published in JAMA Network Open, in patients who underwent radical nephroureterectomy for upper tract urothelial carcinoma, a history of urinary stones was associated with significantly worse cancer-specific and disease-free survival....
Safety and Benefit of Radiation Therapy for High-Risk Muscle-Invasive Bladder Cancer
Following cystectomy, patients with muscle-invasive bladder cancer at high risk for recurrence may safely be treated with radiotherapy and may achieve an improvement in locoregional control compared with observation. These findings, which come from the phase III BART trial presented in a plenary...
Advanced Urothelial Carcinoma: PPARG Inhibitor Shows Preliminary Efficacy
Each year, nearly 85,000 Americans are diagnosed with bladder cancer, and about 17,500 individuals die from the disease. Urothelial carcinoma is the most frequent type of bladder cancer, constituting over 90% of cases in industrialized nations. Up to two-thirds of advanced urothelial carcinomas are ...
Disitamab Vedotin Plus Toripalimab vs Chemotherapy in HER2-Expressing Advanced Urothelial Cancer
In a Chinese phase III trial (RC48-C016) reported at the recent ESMO Congress and in The New England Journal of Medicine, Sheng et al found that the combination of the HER2-directed antibody-drug conjugate disitamab vedotin and the PD-1 inhibitor toripalimab-tpzi improved progression-free survival...
Perioperative Immunotherapy Regimen Improves Outcomes in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
A perioperative regimen of the antibody-drug conjugate enfortumab vedotin-ejfv plus the PD-1 inhibitor pembrolizumab significantly improved outcomes vs radical cystectomy alone in patients with muscle-invasive bladder cancer who were ineligible for or declined cisplatin-based chemotherapy. Results...
New Approvals in Breast and Bladder Cancers
Here are brief reports on three oncology approvals by the U.S. Food and Drug Administration (FDA) in September 2025: • Estrogen Receptor Antagonist in Advanced or Metastatic Breast Cancer: The FDA has approved imlunestrant (Inluriyo), an estrogen receptor antagonist, for adults with estrogen...
Muscle-Invasive Bladder Cancer: IMvigor011 Trial Investigates ctDNA-Guided Adjuvant PD-L1 Inhibition
Patients with muscle-invasive bladder cancer who tested positive for circulating tumor DNA (ctDNA) after cystectomy may benefit from immunotherapy with the PD-L1 inhibitor atezolizumab compared to placebo, whereas ctDNA-negative patients may potentially be spared unnecessary treatment. These...
Adjuvant Radiation Therapy Safe and Beneficial in Locally Advanced Muscle-Invasive Bladder Cancer
Adjuvant radiation therapy following radical cystectomy and chemotherapy was found to be safe and efficacious for patients with locally advanced muscle-invasive bladder cancer, according to findings from the phase III randomized BART trial presented at the American Society for Radiation Oncology...
Acute Cystitis May Signal Urogenital Cancer
Acute cystitis signaled the presence of urogenital cancers in middle-aged men and women, according to the results of a Swedish cohort study published in BMJ Public Health. Based on these findings, the researchers suggested that acute cystitis could be used as a clinical marker for urogenital...
Addition of Neoadjuvant TAR-200 to Cetrelimab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
In an interim analysis of a phase II trial (SunRISe-4) reported in The Lancet Oncology, Necchi et al found that the addition of neoadjuvant TAR-200—a targeted releasing system that provides sustained delivery of gemcitabine within the bladder—to the PD-1 inhibitor cetrelimab resulted in a higher...
FDA Approves Gemcitabine Intravesical System for Non–Muscle-Invasive Bladder Cancer
The U.S. Food and Drug Administration (FDA) has approved the gemcitabine intravesical system (Inlexzo) for adults with bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors. The gemcitabine intravesical system is...
New Drug-Releasing System Eliminates Bladder Cancer in Over 80% of Patients in a Phase II Trial
A new drug-releasing system, TAR-200, eliminated tumors in 82% of patients in the phase II SunRISe-1 trial (ClinicalTrials.gov identifier NCT04640623) for individuals with high-risk non–muscle-invasive bladder cancer whose disease had previously resisted treatment. In the majority of cases, the...
Urothelial Cancer Survival in the Eras Before and After Immune Checkpoint Inhibitors and Antibody-Drug Conjugates
As reported in JAMA Network Open by Mamtani et al, a retrospective cohort study of patients with metastatic urothelial cancer showed population-level increases in survival after the introduction of novel cancer therapeutics—immune checkpoint inhibitors (ie, pembrolizumab and atezolizumab) and...
utDNA May Help to Personalize Bladder Cancer Treatment
Results of a multi-institutional study published by St-Laurent et al in Science Direct revealed that testing urine-based tumor DNA (utDNA) may help to predict which patients with bladder cancer are at higher risk for recurrence after not responding to first-line treatment. The study analyzed utDNA...
Genitourinary Oncology Highlights: Treatment Advances in Renal Cell, Bladder, Urothelial, and Prostate Cancers
The 2025 ASCO Annual Meeting has officially concluded. Our sincere thanks to the global oncology community and ASCO for creating such a remarkable forum advancing cancer care. Here we highlight the most impactful updates in genitourinary tumors from this year’s meeting. Kidney Cancer: Long-Term...
FDA Approves Mitomycin Intravesical Solution for Recurrent Low-Grade Intermediate-Risk Non–Muscle-Invasive Bladder Cancer
On June 12, 2025, the U.S. Food and Drug Administration (FDA) approved mitomycin intravesical solution (Zusduri) for adult patients with recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer. Mitomycin intravesical solution is a reverse thermal hydrogel formulation of mitomycin...
NCCN Clinical Practice Guidelines in Oncology: 2025 Updates
The National Comprehensive Cancer Network (NCCN) released its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®) in 1996, covering eight tumor types. Today, guidelines are available for more than 60 tumor types, subtypes, and related topics. During the NCCN’s 30th Annual...
Case 3: Perioperative Strategies for a Patient With Muscle-Invasive Bladder Cancer and Borderline Renal Function
This is Part 3 of Immunotherapy Approaches in Muscle-Invasive Bladder Cancer, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Matthew Galsky, Srikala Sridhar, and Abhishek Tripathi discuss perioperative treatment strategies for a patient with muscle-invasive bladder cancer and borderline renal function. The patient is a 74-year-old man with a history of hypertension who is seen in the ER for lower abdominal discomfort. A CT scan reveals a bladder mass, and labs are notable for a creatinine clearance of 43 mL/min. He undergoes cystoscopy and transurethral resection of the bladder tumor (TURBT). Pathology reveals high-grade urothelial cancer with invasion of the lamina propria but no muscularis propria present in the sample. In the conversation that follows, the faculty discuss the importance of repeat TURBT in patients with high-grade urothelial cancer and no muscularis propria in the pathology specimen, the clinical implications of the NIAGARA study, whether bladder-sparing trimodality approaches could be an option, and more.
Case 2: Adjuvant Therapy in a Patient With Cisplatin-Ineligible, Pathologic Node-Positive Muscle-Invasive Bladder Cancer
This is Part 2 of Immunotherapy Approaches in Muscle-Invasive Bladder Cancer, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Matthew Galsky, Srikala Sridhar, and Abhishek Tripathi discuss adjuvant treatment options for a patient with cisplatin-ineligible, pathologic node-positive muscle-invasive bladder cancer. The patient is an 82-year-old woman with a history of non–muscle-invasive bladder cancer who was subsequently treated with intravesical docetaxel plus gemcitabine for high-grade cT1 recurrence. On staging cystoscopy plus transurethral resection of the bladder tumor, she is found to have muscle-invasive bladder cancer. A CT scan reveals bladder wall thickening, and lab work is notable for creatinine clearance of 35 mL/min. She proceeds with radical cystectomy, and pathology reveals pT3N0 urothelial cancer of the bladder, and she has detectable ctDNA. In the conversation that follows, the faculty discuss how to counsel older or frail patients who are not eligible for upfront neoadjuvant chemotherapy, the role of adjuvant immunotherapy, and the impact on ctDNA on outcomes.
Case 1: Neoadjuvant Therapy in a Patient in Muscle-Invasive Bladder Cancer With Squamous Differentiation
This is Part 1 of Immunotherapy Approaches in Muscle-Invasive Bladder Cancer, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Matthew Galsky, Srikala Sridhar, and Abhishek Tripathi discuss neoadjuvant treatment options for a patient with muscle-invasive bladder cancer and squamous differentiation. The patient is a 65-year-old man with a history of hypertension and type 2 diabetes mellitus who presents with gross hematuria. A CT scan reveals a bladder mass, a single borderline enlarged pelvic lymph node, and mild right-sided hydronephrosis. Lab work is notable for a creatinine clearance of 65 mL/min and urinalysis showing red blood cells. Cystoscopy reveals a bladder tumor, and he undergoes cystoscopy and transurethral resection of the bladder tumor. Pathology reveals muscle-invasive urothelial cancer of the bladder with ~55% squamous differentiation. In the conversation that follows, the faculty discuss the relevance of histology in determining his treatment course, whether immune checkpoint blockade should be considered, the role of local therapy, and more.
Novel Strategy May Enhance Sensitivity, Accuracy of Monitoring Cancer in Blood Samples
A whole-genome sequencing–based, error-corrected method for detecting cancer from blood samples could be more sensitive and accurate in monitoring disease status posttreatment among patients with cancer compared with prior methods, according to a recent study published by Cheng et al in Nature...
Neoadjuvant Durvalumab Plus Chemotherapy for High-Risk Upper-Tract Urothelial Carcinoma
In a French phase II trial (iNDUCT-GETUG V08) reported in the Journal of Clinical Oncology, Houédé et al found evidence of activity of neoadjuvant durvalumab plus chemotherapy in patients with high-risk, upper tract urothelial carcinoma. Study Details In this multicenter open-label trial, 45...
FDA Approves Perioperative Durvalumab for Muscle-Invasive Bladder Cancer
On March 28, the U.S. Food and Drug Administration (FDA) approved the PD-L1 inhibitor durvalumab (Imfinzi) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle-invasive bladder ...
Enfortumab Vedotin–Based Approaches to Metastatic Urothelial Carcinoma
In a systematic review and meta-analysis reported in JAMA Network Open, Yajima et al found that both pembrolizumab plus enfortumab vedotin-ejfv and enfortumab vedotin alone were active in the first-line setting and later lines of therapy, respectively, in metastatic urothelial carcinoma. Study...
TB Vaccination Could Enhance BCG Response in Patients With Non–Muscle-Invasive Bladder Cancer, Study Finds
Two doses of a simple tuberculosis (TB) vaccination after surgery helps the immune system fight cancer cells and may improve patient outcomes among those with non–muscle-invasive bladder cancer, according to a pilot study of 40 patients. Initial results from the RUTIVAC-1 Trial were presented by...
Can Adding Antihistamines to Second-Line Therapy Improve Outcomes in Advanced Urothelial Carcinoma?
As reported in the journal Urologic Oncology: Seminars and Original Investigations by Fallara et al, an analysis of individual patient data from the IMvigor210 and IMvigor211 trials revealed that concomitant second-line treatment of locally advanced or metastatic urothelial carcinoma with...
Enfortumab Vedotin Plus Pembrolizumab Continues to Show Benefit in Metastatic Urothelial Carcinoma
In previously untreated patients with locally advanced or metastatic urothelial carcinoma, use of the antibody-drug conjugate enfortumab vedotin-ejfv in combination with the PD-1 inhibitor pembrolizumab continues to demonstrate a significant survival benefit over chemotherapy, according to updated...
