Alliance for Clinical Trials in Oncology study shows positive results for patients with muscle-invasive urothelial carcinoma
2024-01-26
(Press-News.org) Patients with muscle-invasive urothelial cancer and a high risk of recurrence after surgery may have a new treatment option. The Alliance for Clinical Trials in Oncology today announced positive results from the phase III AMBASSADOR (A031501) trial for the adjuvant treatment of patients with localized muscle-invasive urothelial carcinoma (MIUC) and locally advanced urothelial carcinoma. Late-breaking data from the trial are being presented during an oral abstract session at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (abstract #LBA531) today.
“Patients with muscle-invasive bladder cancer after radical surgery are at high risk of disease recurrence and metastases. Pembrolizumab versus observation significantly reduced the risk of disease recurrence for these patients,” said Andrea B. Apolo, MD, study chair for the AMBASSADOR trial and Head of the Bladder Cancer Section of the Genitourinary Malignancies Branch and Director of the Bladder Cancer and Genitourinary Tumors Multidisciplinary Clinic in the Center for Cancer Research of the National Cancer Institute. “This is long awaited data in the bladder cancer community.”
At a pre-specified interim analysis review, pembrolizumab, an anti-PD-1 therapy, demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus observation in patients after surgery, meeting one of the trial’s dual primary endpoints. After a median follow-up of 22.3 months, pembrolizumab reduced the risk of DFS or death by 31% (HR=0.69 [95% confidence interval (CI), 0.55-0.87]; p=0.0013) versus observation in patients after surgery. Median DFS was 29.0 months (95% CI, 21.8-not evaluable [NE]) for pembrolizumab and 14.0 months (95% CI, 9.7-20.2) for observation, an improvement of 15 months. These DFS results were consistent regardless of patients’ PD-L1 expression status. The trial’s other dual primary endpoint of overall survival (OS) did not reach statistical significance at the time of this interim analysis and will continue to be followed as data mature (HR=0.98 [95% CI, 0.76-1.26]; p=0.88). After a median follow-up of 36.9 months, median OS was 50.9 months (95% CI, 43.9-NE) for pembrolizumab versus 55.8 months (95% CI, 53.3-NE) for observation (HR=0.98 [95% CI, 0.76-1.26]; p=0.88).
The safety profile of pembrolizumab in this trial was consistent with that observed in previously reported studies, and no new safety signals were identified. Grade 3+ adverse events (side effects that are severe or medically significant but not immediately life-threatening) occurred in 48.4% of patients receiving pembrolizumab versus 31.8% of patients under observation.
17.4% percent of patients receiving pembrolizumab withdrew from the trial without event, versus 27.2% from the observation arm. Seventy-six patients (22%) in the observation arm subsequently received an immune checkpoint inhibitor.
AMBASSADOR (A031501) is a randomized, open-label phase III trial evaluating pembrolizumab versus observation for the adjuvant treatment of localized MIUC and locally advanced urothelial carcinoma. The dual primary endpoints are OS and DFS, and secondary endpoints include OS and DFS in PD-L1 positive and negative patients. The trial enrolled 702 patients who were randomized to receive pembrolizumab (200 mg intravenously every three weeks for up to 18 cycles) or undergo observation.
It is estimated that approximately 82,290 people in the U.S. will be diagnosed with bladder cancer in 2023. Globally, there were approximately 573,000 new cases and 212,000 deaths from bladder cancer in 2020. Muscle-invasive bladder cancer is bladder cancer that has spread into the deep muscle of the bladder wall, and locally advanced urothelial cancer is cancer that begins in the urothelial cells and has spread from where it started to nearby tissue or lymph nodes. Despite surgery, up to 50% of patients with bladder cancer experience recurrence within 12 months.
AMBASSADOR is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and is being led and conducted by the NCI funded Alliance for Clinical Trials in Oncology with participation from the NCI funded national clinical trials network (NCTN) as part of Merck’s collaboration with the NCI through a Cooperative Research and Development Agreement (CRADA). To learn more about the AMBASSADOR trial, visit ClinicalTrials.gov.
# # #
Reference: Alliance A031501: Phase III randomized adjuvant study of pembrolizumab in muscle invasive and locally advanced urothelial carcinoma (AMBASSADOR) versus observation. A full description of this clinical trial can be found at https://clinicaltrials.gov/study/NCT03244384.
The Alliance for Clinical Trials in Oncology develops and conducts clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as research methods to alleviate side effects of cancer and cancer treatments. The Alliance is part of the National Clinical Trials Network (NCTN) funded by the National Cancer Institute (NCI) and serves as a research base for the NCI Community Research Oncology Program (NCORP). The Alliance comprises nearly 10,000 cancer specialists at hospitals, medical centers, and community clinics across the United States and Canada. To learn more, visit www.AllianceforClinicalTrialsinOncology.org.
END
ELSE PRESS RELEASES FROM THIS DATE:
2024-01-26
Waltham — January 25, 2024 — A newly developed neural network is highly accurate in identifying key landmarks important in breast surgery – opening the potential for objective assessment of breast symmetry, suggests a study in the February issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons (ASPS). The journal is published in the Lippincott portfolio by Wolters Kluwer.
"Neural networks and machine learning have the potential to improve evaluation of breast symmetry in reconstructive ...
2024-01-26
This study is led by Prof. Yuliang Cao and Prof. Yongjin Fang (College of Chemistry and Molecular Sciences, Wuhan University). The experiments were performed by using ammonia etching on highly crystalline Na2NiFe(CN)6 (denoted as NaNiHCF) to activate the sodium storage sites and accelerate the Na+ transport.
Fe(CN)6 vacancies and the water molecules in the lattice, which are concomitant during the synthesis, however, lead to poor electrochemical performance. Hence, optimizing the crystal structures of PBAs to boost their electrochemical performance is currently a hot spot in the research ...
2024-01-26
This study is led by Prof. Xianqun Fan (Department of Ophthalmology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital).
Gene editing ushers in a new era of disease treatment since many genetic diseases are caused by base-pair mutations in genomic DNA. With the rapid development of genome editing technology, novel editing tools such as base editing and prime editing have attracted public attention, heralding a great leap forward in this field.
Prime editing (PE) was proposed by David Liu’s team in 2019, which is characterized ...
2024-01-26
In the realm of clean energy, metal halide perovskite solar cells (PSCs) have emerged as a groundbreaking focus, capturing significant attention for their extraordinary advancements. In just over a decade, their certified power conversion efficiency (PCE) has skyrocketed to 26.1%, approaching the upper limits seen in traditional crystalline silicon cells. What sets PSCs apart is their potential to surpass the 30% PCE threshold [1].
The key to optimizing solar devices lies in the deposition of high-quality perovskite films. Achieving minimal defect density and exceptional homogeneity becomes crucial for enhancing device performance. One commonly employed strategy involves introducing ...
2024-01-26
This study, led by Prof. Jiuhui Qu, Dr. Qinghua Ji, and Dr. Wei Zhang from Tsinghua University, focuses on addressing water scarcity by exploring atmospheric water harvesting. The water in the air originates from both natural and forced evaporation, with condensation being the final and crucial step in water harvesting. Condensation involves nucleation, growth, and shedding of water droplets, which are then collected. However, uncontrollable growth of condensed droplets leading to surface flooding is a pressing challenge due to insufficient driving forces, posing a threat to sustainable condensation.
To expedite this process and achieve orderly ...
2024-01-26
To improve the care coordination competency of nurses involved in the management of critically ill patients on life support, an electronic app—NCCCS—was developed by Associate Professor Chie Takiguchi of Toho University and Professor Tomoko Inoue of International University of Health and Welfare.
The NCCCS app utilizes the scoring system referred to as the Nurses' Care Coordinate Competency Scale (NCCCS), developed by Dr. Takiguchi et al. in 2017, and it is currently being translated into Chinese, Italian, Polish, and Persian. This app offers immediate feedback to nurses caring for critically ill patients on life ...
2024-01-26
Scientists from Hiroshima University undertook a study of dragonfly wings in order to better understand the relationship between a corrugated wing structure and vortex motions. They discovered that corrugated wings exhibit larger lift than flat wings.
Their work was published in the journal Physical Review Fluids on December 7, 2023.
The researchers set out to determine if the corrugation of a dragonfly's wing is a secret ingredient for boosting lift. While past research has largely zoomed in ...
2024-01-26
Amylases are among the most important biotechnological and industrial enzymes that can be applied in various sectors, such as food, pharmaceuticals, textiles, chemicals, paper, and detergents.
The enzymes’ costs come from a range of factors including the quantity produced, the production process, the expense of its recovery, and the degree of purity at which it will be marketed, etc. The use of agro-industrial substrates and microorganisms brings the potential to low-cost enzyme production. Meanwhile, due to the ability to improve physical and chemical resistance to industrial environmental extremes, such as high temperature and pH, as well ...
2024-01-26
Staying hydrated and consuming appropriate amounts of salt is essential for the survival of terrestrial animals, including humans. The human brain has several regions constituting neural circuits that regulate thirst and salt appetite, in intriguing ways.
Previous studies suggested that water or salt ingestion quickly suppresses thirst and salt appetite before the digestive system absorbs the ingested substances, indicating the presence of sensing and feedback mechanisms in digestive organs that help real-time thirst and salt appetite modulation in response to drinking ...
2024-01-26
Early in the pandemic, clinicians noticed that certain immunocompromised patients were experiencing persistent SARS-CoV-2 infections, some lasting weeks to months at a time.
This raised concerns that one of these cases could be the source of an emerging viral variant that has benefited from an extended battle with the immune system.
A prospective study published in the journal Lancet Microbe provides more clarity on which patient populations are at higher risk for prolonged infections —and hints that this fear is likely unwarranted.
The ...
LAST 30 PRESS RELEASES:
[Press-News.org] Alliance for Clinical Trials in Oncology study shows positive results for patients with muscle-invasive urothelial carcinoma
