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Bladder Cancer
Immunotherapy

IMvigor130: First-Line Atezolizumab Plus Chemotherapy vs Chemotherapy Alone in Advanced Urothelial Cancer

As reported in The Lancet by Matthew D. Galsky, MD, of Icahn School of Medicine at Mount Sinai, and colleagues, the phase III IMvigor130 trial has shown prolonged progression-free survival with first-line atezolizumab plus platinum-based chemotherapy vs platinum-based chemotherapy alone in patients ...

bladder cancer
immunotherapy

Christopher Sweeney, MBBS, and Thomas Powles, MD, PhD, on Urothelial Cancer: The JAVELIN Bladder 100 Study on Avelumab vs Best Supportive Care

Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, talks with Thomas Powles, MD, PhD, of Queen Mary University of London, about the first study to demonstrate a survival advantage with avelumab for metastatic urothelial cancer. In the trial, avelumab improved median overall survival by 21.4 months compared with 14.3 months with best supportive care (Abstract LBA1).

Bladder Cancer
Immunotherapy

Expert Point of View: Jonathan E. Rosenberg, MD

“These data are solid, showing a 7-month improvement in overall survival in patients with stable disease or better after first-line chemotherapy. This is roughly a 50% improvement in survival, which is clinically meaningful. Also, progression-free survival was significantly increased with...

Bladder Cancer
Immunotherapy

Maintenance Avelumab Improves Survival in Advanced Bladder Cancer

Maintenance therapy with avelu­mab and best supportive care significantly prolonged overall survival vs best supportive care alone in patients with advanced urothelial carcinoma that did not progress on first-line platinum-based chemotherapy, according to an interim analysis of the phase III...

Bladder Cancer

Mitomycin Gel for Low-Grade Upper Tract Urothelial Cancer

On April 15, 2020, mitomycin gel was approved for the treatment of adult patients with low-grade upper tract urothelial cancer.1,2 Mitomycin gel is for pyelocalyceal use alone and not for intravenous, topical, or oral administration. Supporting Efficacy Data Approval was based on findings in the...

bladder cancer
immunotherapy

Metastatic Urothelial Cancer: A Conversation on State-of-the-Art Treatment Before the ASCO20 Virtual Scientific Program

As Thomas Powles, MD, PhD, of Queen Mary University of London, prepares to deliver his late-breaking presentation at the ASCO20 Virtual Scientific Program (LBA-1), he talks with Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, about current therapy: PD1/PDL1 inhibition in second-line treatment and as monotherapy in the first-line setting, as well as the concept of maintenance switch.

Bladder Cancer

Low-Intensity Surveillance as an Option for Some Patients With Non–Muscle Invasive Bladder Cancer

Low-intensity cystoscopic surveillance may be a viable option for patients with high-risk, non–muscle invasive bladder cancer, according to data from a paper presented to the media during a special session moderated by the American Urological Association (AUA) on May 15. The research was also...

Bladder Cancer

Chemoablation of Low-Grade Upper Tract Urothelial Cancer With Mitomycin-Containing Reverse Thermal Gel

In the single-arm phase III OLYMPUS trial reported in The Lancet Oncology, Kleinmann et al found that primary chemoablation of low-grade upper tract urothelial carcinoma using a mitomycin-containing reverse thermal gel (UGN-101) resulted in disease eradication in more than half of patients. As...

Bladder Cancer
Immunotherapy

'Switch Maintenance' Pembrolizumab for Metastatic Urothelial Cancer

In a phase II study reported in the Journal of Clinical Oncology, Matthew D. Galsky, MD, and colleagues found that maintenance pembrolizumab produced additional responses and improved progression-free survival vs placebo in patients with metastatic urothelial cancer who had at least stable disease...

Bladder Cancer

FDA Approves Mitomycin Gel for Low-Grade Upper Tract Urothelial Cancer

On April 15, the U.S. Food and Drug Administration (FDA) approved mitomycin (Jelmyto) for adult patients with low-grade upper tract urothelial cancer. OLYMPUS Trial Efficacy determination was based on OLYMPUS, an ongoing, single-arm, multicenter trial enrolling 71 patients with treatment-naive or...

Immunotherapy
Solid Tumors
Lung Cancer
Bladder Cancer
Gynecologic Cancers
CNS Cancers

FDA Pipeline: Priority Reviews for Immunotherapy Based on Biomarker Status, Combination First-Line Therapy in Lung Cancer

Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to an immunotherapeutic agent for solid tumors with a high tumor mutational burden and to a combination treatment for the first-line treatment of metastatic or recurrent non–small cell lung cancer. The agency...

Prostate Cancer
Bladder Cancer
Kidney Cancer
Immunotherapy

Brief Highlights on Novel Therapies for Prostate, Bladder, and Kidney Cancers

Attendees gathered at the 2020 Genitourinary Cancers Symposium in San Francisco to hear the latest news about treating patients with cancers of the prostate, bladder, kidneys, and testicles. In addition to the comprehensive coverage of the meeting in The ASCO Post, here are some brief highlights...

Breast Cancer
Bladder Cancer
Lymphoma
Immunotherapy

FDA Pipeline: Approval of New Dosing for Biosimilar, Plus Two Fast Track Designations

The U.S. Food and Drug Administration (FDA) recently approved a new dose for a biosimilar referencing trastuzumab and granted Fast Track designations to agents for patients with urothelial cancer and follicular lymphoma. Approval of Multidose Vial of Trastuzumab Biosimilar The FDA approved a...

Bladder Cancer
Immunotherapy

Expert Point of View: Philip J. Saylor, MD

Philip J. Saylor, MD, Attending Physician at Massachusetts General Hospital and Assistant Professor at Harvard Medical School, Boston, commented on this study. “The results that were presented are clearly exciting and cause us to look forward to a likely phase III study of this strategy. The high...

Bladder Cancer
Immunotherapy

Early Data Show Activity for Enfortumab Vedotin Plus Pembrolizumab in Advanced Bladder Cancer

It may be possible to use a platinum-free combination as first-line treatment for advanced or metastatic urothelial carcinoma in cisplatin-ineligible patients, if results of the phase Ib/II EV-103 trial hold up. The combination of the newly approved antibody-drug conjugate (enfortumab vedotin) and...

Bladder Cancer

Adjuvant Gemcitabine/Platinum-Based Chemotherapy vs Surveillance for Upper Tract Urothelial Carcinoma: POUT Trial

In the phase III POUT trial, reported in The Lancet, Alison Birtle, MD, and colleagues found that adjuvant gemcitabine/platinum chemotherapy was associated with improved disease-free survival vs surveillance in patients with locally advanced urothelial carcinoma of the upper urinary tract. As...

Lung Cancer
Lymphoma
Bladder Cancer
Head and Neck Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in Lung Cancers, Lymphoma

This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for non–small cell and small cell lung cancers, as well as for diffuse large-B cell lymphoma (DLBCL); Breakthrough Therapy designation to an antibody-drug conjugate for bladder cancer; and a double Fast...

Immunotherapy
Bladder Cancer

Pembrolizumab for BCG-Unresponsive, High-Risk Non–Muscle Invasive Bladder Cancer

On January 8, 2020, pembrolizumab was approved for treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.1,2...

bladder cancer
immunotherapy

Nicholas D. James, PhD, MBBS, on Bladder Cancer: Cetuximab With Chemoradiotherapy

Nicholas D. James, PhD, MBBS, of The Institute of Cancer Research in London, discusses results from a phase I/II feasibility study that showed the combination of cetuximab, chemoradiation, fluorouracil, and mitomycin yields high bladder cancer control rates with acceptable toxicity and quality of life, meriting further evaluation in a randomized trial (Abstract 491).

bladder cancer

Syed A. Hussain, MD, on Muscle-Invasive Bladder Cancer: NEO-BLADE Trial of Nintedanib Plus Chemotherapy

Syed A. Hussain, MD, of the University of Sheffield, discusses phase II findings comparing nintedanib or placebo in combination with gemcitabine and cisplatin in locally advanced muscle-invasive bladder cancer. The data showed that adding nintedanib was safe and well tolerated, with a significant improvement in progression-free and overall survival at 1 and 2 years (Abstract 438).

immunotherapy
bladder cancer

Jonathan E. Rosenberg, MD, on Locally Advanced or Metastatic Urothelial Carcinoma: Enfortumab Vedotin Plus Pembrolizumab

Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, discusses study results which showed that, in first-line cisplatin-ineligible patients with metastatic urothelial carcinoma, enfortumab vedotin/pembrolizumab demonstrated activity and durability, with a manageable safety profile (Abstract 441).

Bladder Cancer
Immunotherapy

2020 GU Cancers Symposium: Enfortumab Vedotin Plus Pembrolizumab in Bladder Cancer

In patients with metastatic urothelial carcinoma, platinum chemotherapy is the standard of care in the first-line setting; however, for patients who are ineligible for platinum treatment, the alternative standard—gemcitabine plus carboplatin—can be poorly tolerated and have limited durability and...

Bladder Cancer
Kidney Cancer
Prostate Cancer
Issues in Oncology

2020 GU Cancers Symposium: Fear of Recurrence, Patients’ Prognostic Understanding Examined in Genitourinary Cancers

In studies to be presented at the 2020 Genitourinary Cancers Symposium (Abstracts 649 and 665), researchers examined the prevalence of fear of cancer recurrence in patients with renal cell carcinoma and evaluated the prognostic understanding patients with genitourinary cancer possess of their...

Bladder Cancer

Enfortumab Vedotin in Metastatic Urothelial Carcinoma

In the phase I EV-101 trial reported in the Journal of Clinical Oncology, Rosenberg et al found that the antibody-drug conjugate enfortumab vedotin had no maximum tolerated dose and was active in patients with metastatic urothelial carcinoma at the dose selected for phase II evaluation. The agent...

Bladder Cancer

TIVO-3: Third- or Fourth-Line Tivozanib vs Sorafenib in Metastatic Renal Cell Carcinoma

As reported in The Lancet Oncology by Brian I. Rini, MD, and colleagues, the phase III TIVO-3 trial has shown a statistically significant increase in progression-free survival with tivozanib vs sorafenib as a third- or fourth-line treatment for advanced renal cell carcinoma. Study Details The...

Bladder Cancer

Enfortumab Vedotin-ejfv for Previously Treated Advanced Urothelial Cancer

On December 18, 2019, the antibody-drug conjugate enfortumab vedotin-ejfv (PadcevTM) was granted accelerated approval for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed cell death protein 1 (PD-1) or programmed cell...

Bladder Cancer
Hepatobiliary Cancer

FDA Pipeline: Fast Track/Orphan Drug Designation for Cholangiocarcinoma Treatment, Breakthrough Device Designation for Bladder Cancer Test

This week, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to infigratinib for patients with advanced or metastatic cholangiocarcinoma with a certain genetic mutation, and Orphan Drug designation to the treatment for patients with cholangiocarcinoma. The FDA also granted...

Bladder Cancer
Immunotherapy

FDA Approves PD-1 Inhibitor for BCG-Unresponsive, High-Risk Non–Muscle Invasive Bladder Cancer

Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have...

Bladder Cancer
Immunotherapy

JAVELIN Bladder 100 Study of Avelumab for Urothelial Cancer Meets Primary Endpoint

The phase III JAVELIN Bladder 100 trial met its primary endpoint of overall survival at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy and who were randomly...

Bladder Cancer

Does the Addition of Ramucirumab to Docetaxel Improve Overall Survival in Previously Treated Urothelial Carcinoma?

As reported in The Lancet Oncology by Daniel P. Petrylak, MD, and colleagues, the phase III RANGE trial has shown no significant improvement in overall survival with the addition of ramucirumab to docetaxel in patients with locally advanced or metastatic urothelial carcinoma previously treated...

Lung Cancer
Bladder Cancer
Colorectal Cancer
Hematologic Malignancies
Myelodysplastic Syndromes
Breast Cancer
Head and Neck Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in SCLC, Bladder Cancer, Colorectal Cancer

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Reviews for treatments in extensive-stage small cell lung cancer (SCLC), non–muscle invasive bladder cancer, and BRAF V600E–mutant colorectal cancer. The Agency also recently issued multiple Breakthrough Therapy designations and ...

Bladder Cancer

FDA Approves Enfortumab Vedotin-ejfv for Previously Treated Advanced Urothelial Cancer

On December 18, the U.S. Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (Padcev) for adult patients with locally advanced or metastatic urothelial cancer who have previously received neoadjuvant or adjuvant treatment with a programmed cell death protein 1 ...

Bladder Cancer

Does the Addition of Ramucirumab to Docetaxel Improve Overall Survival in Previously Treated Urothelial Carcinoma?

As reported in The Lancet Oncology by Daniel P. Petrylak, MD, and colleagues, the phase III RANGE trial has shown no significant improvement in overall survival with the addition of ramucirumab to docetaxel in patients with locally advanced or metastatic urothelial carcinoma previously treated with ...

Prostate Cancer
Breast Cancer
Bladder Cancer
Pancreatic Cancer
Kidney Cancer
Thyroid Cancer
Gynecologic Cancers
Immunotherapy

ESMO Congress 2019: Quick Takes From Key Clinical Trials

The ESMO Congress continues to grow as a pivotal platform for research in clinical oncology. At the ESMO Congress 2019, important findings were showcased in more than 2,200 studies, including 93 late-breaking abstracts. The ASCO Post summarized much of that news in separate articles over several...

Bladder Cancer

IMvigor130 Trial: Atezolizumab Plus Chemotherapy for Metastatic Urothelial Cancer

Treatment with atezolizumab plus chemotherapy extended progression-free survival by 1.9 months vs chemotherapy alone in patients with metastatic urothelial cancer, according to the early results of the IMvigor130 trial, which were presented at the European Society for Medical Oncology (ESMO)...

Prostate Cancer
Bladder Cancer
Hematologic Malignancies
Breast Cancer
CNS Cancers
Leukemia
Skin Cancer

FDA Pipeline: Advances in Prostate Cancer, Urothelial Cancer, Myelofibrosis, and More

In the past few weeks, the U.S. Food and Drug Administration (FDA) has issued regulatory decisions in prostate cancer, urothelial cancer, myelofibrosis, breast cancer, pediatric brain cancer, leukemia, and skin cancer. Breakthrough Therapy Designation for Niraparib in Metastatic...

Bladder Cancer
Immunotherapy

ESMO 2019: IMvigor130: Addition of Atezolizumab to Platinum-Based Chemotherapy in Advanced Urothelial Carcinoma

Patients with locally advanced or metastatic urothelial carcinoma demonstrated prolonged progression-free survival with the addition of atezolizumab to first-line platinum-based chemotherapy vs treatment with chemotherapy alone, according to phase III data from the IMvigor130 study presented by...

bladder cancer
immunotherapy

Thomas Powles, MD, PhD, and Enrique Grande, MD, PhD, on Urothelial Carcinoma: Atezolizumab and Platinum-Based Chemotherapy

Thomas Powles, MD, PhD, of Queen Mary University of London, and Enrique Grande, MD, PhD, of MD Anderson Cancer Center, Madrid, discuss findings of the phase III IMvigor130 trial on the efficacy and safety of atezolizumab as monotherapy or combined with platinum-based chemotherapy vs placebo plus platinum-based chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (Abstract LBA14).

bladder cancer
immunotherapy

Thomas Powles, MD, PhD, on Metastatic Urothelial Cancer: Durvalumab Plus Targeted Treatments

Thomas Powles, MD, PhD, of Queen Mary University of London, discusses the first study to examine immunotherapy and targeted treatment combinations with a personalized approach in bladder cancer. FGF, TORC1/2, and PARP inhibitors were explored in combination with durvalumab in selected patients (Abstract 902O).

Bladder Cancer
Issues in Oncology

The Fight Against Breast Cancer Illustrates the Health-Care Challenges of Women in Poverty

"Of all the forms of inequality, injustice in health is the most shocking and the most inhumane….” —Dr. Martin Luther King, Jr Progress has been made in expanding access to health care for low-income populations, but the quality of care still lags behind and can result in less successful outcomes...

bladder cancer

Gemcitabine/Eribulin in Cisplatin-Ineligible Metastatic Urothelial Carcinoma

In the final analysis from a phase II California Cancer Consortium trial (NCI-9653) reported in the Journal of Clinical Oncology, Sadeghi et al found the combination of gemcitabine and eribulin showed activity in cisplatin-ineligible patients with metastatic urothelial carcinoma. Study Details...

bladder cancer

Enfortumab Vedotin in Platinum- and Anti–PD-1/L1–Pretreated Urothelial Carcinoma

In the phase II EV-201 trial reported in the Journal of Clinical Oncology, Rosenberg et al found the antibody-drug conjugate enfortumab vedotin showed high activity in patients with metastatic urothelial carcinoma who had previously received platinum-based therapy and anti–programmed cell...

Bladder Cancer

Johns Hopkins Awarded $3.2 Million NIH Grant for Early-Stage Bladder Cancer Research

Researchers at the Johns Hopkins Kimmel Cancer Center, the Greenberg Bladder Cancer Institute, the Bloomberg-Kimmel Institute for Cancer Immunotherapy, the Brady Urological Institute, and the Center for Computational Genomics at Johns Hopkins have received a $3.2 million grant from the National...

bladder cancer

Erdafitinib in FGFR-Altered Advanced Urothelial Carcinoma

As reported in The New England Journal of Medicine by Loriot et al, the fibroblast growth factor receptor 1-4 tyrosine kinase inhibitor erdafitinib showed activity in FGFR-altered advanced urothelial carcinoma. Study Details The study enrolled patients from sites in 14 countries between May...

bladder cancer

Conditional Reprogramming of Urine Cultures for Bladder Cancer

A research team led by investigators from Georgetown University Medical Center and Fudan University in China has devised a noninvasive and individualized technique for detecting and treating bladder cancer. Their findings were published by Jiang et al in Protein & Cell. The method uses a...

Bladder Cancer

New NCCN Guidelines for Patients®: Bladder Cancer

THE TREATMENT LANDSCAPE for bladder cancer has changed dramatically over the past few years, and the National Comprehensive Cancer Network® (NCCN®) recently announced the newly published NCCN Guidelines for Patients®: Bladder Cancer, created with funding through the NCCN Foundation. The guidelines...

lung cancer
gastroesophageal cancer
bladder cancer
gastrointestinal cancer
immunotherapy

Ramucirumab Plus Pembrolizumab in Previously Treated Advanced Gastroesophageal Cancer, NSCLC, and Urothelial Carcinoma

Results from a phase IB trial expansion stage reported in The Lancet Oncology by Herbst et al showed the combination of ramucirumab plus pembrolizumab had manageable toxicity and antitumor activity in previously treated advanced gastroesophageal cancer, non–small cell lung cancer (NSCLC), and ...

bladder cancer

Study Identifies Key Biologic Features of Upper Tract Urothelial Carcinoma

A new study published by Robinson et al in Nature Communications aimed to learn more about the biologic characteristics of upper tract urothelial carcinoma to help develop more targeted therapies. “We discovered the defining biologic characteristics of [upper tract urothelial tumors] that...

Bladder Cancer

Actively Recruiting Clinical Trials for Muscle-Invasive and Non–Muscle-Invasive Bladder Cancers

The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical research trials for both muscle-invasive and non–muscle-invasive bladder cancers. The studies listed here are evaluating the safety and efficacy of combinations of chemotherapy and...

Bladder Cancer
Immunotherapy

Enfortumab Vedotin After Checkpoint Inhibition in Metastatic Urothelial Cancer

A phase II study found that treatment with the antibody-drug conjugate enfortumab vedotin achieved responses in 44% of patients with locally advanced or metastatic urothelial cancer previously treated with platinum chemotherapy and a checkpoint inhibitor. This is a noteworthy study because it...

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