Paller, Amy Siegfried, Elaine Cork, Michael Arkwright, Peter Ramien, Michele Khokhar, Faisal Chen, Zhen Zhang, Annie Cyr, Sonya Eichenfield, Lawrence
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BACKGROUND: Patients with atopic dermatitis (AD), particularly infants and young children, are at greater risk of developing skin infections. In this study, we assessed infection rates in AD patients aged 6 months to 5 years treated with dupilumab. METHODS: In LIBERTY AD PRESCHOOL, a double-blind, placebo-controlled, phase III clinical trial, child...
Brahmer, Julie Long, Georgina Hamid, Omid Garon, Edward Herbst, Roy Andre, Thierry Armand, Philippe Bajorin, Dean Bellmunt, Joaquim Burtness, Barbara
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BACKGROUND: Pembrolizumab has a manageable safety profile as described in its label, which was primarily based on 2799 patients who participated in clinical trials for melanoma or non-small cell lung cancer. Here, we evaluated the safety of pembrolizumab in a broader population of patients from 31 advanced cancer clinical trials across 19 cancer ty...
Hoimes, Christopher Flaig, Thomas Milowsky, Matthew Bilen, Mehmet Gupta, Shilpa Srinivas, Sandy Merchan, Jaime McKay, Rana Petrylak, Daniel Sasse, Carolyn
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WHAT IS THIS SUMMARY ABOUT?: This summary provides the results of a study of two treatments for cancer, enfortumab vedotin and pembrolizumab, that were studied together against locally advanced or metastatic urothelial cancer (la/mUC), a cancer that occurs most commonly in the bladder. WHAT WERE THE RESULTS?: In the 45 patients studied, around 16% ...
Saijo, Atsuro Ogino, Hirokazu Butowski, Nicholas A Tedesco, Meghan R Gibson, David Watchmaker, Payal B Okada, Kaori Wang, Albert S Shai, Anny Salazar, Andres M
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BackgroundCentral nervous system (CNS) WHO grade 2 low-grade glioma (LGG) patients are at high risk for recurrence and with unfavorable long-term prognosis due to the treatment resistance and malignant transformation to high-grade glioma. Considering the relatively intact systemic immunity and slow-growing nature, immunotherapy may offer an effecti...
Patel, Sandip Alonso-Gordoa, Teresa Banerjee, Susana Wang, Ding Naidoo, Jarushka Standifer, Nathan Palmer, Doug Cheng, Lin-Yang Kourtesis, Panagiotis Ascierto, Maria
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BACKGROUND: The combination of monalizumab (anti-NKG2A/CD94) and durvalumab (anti-programmed death ligand-1) may promote antitumor immunity by targeting innate and adaptive immunity. This phase 1/2 study of monalizumab and durvalumab evaluated safety, antitumor activity, and pharmacodynamics in patients with advanced solid tumors. MAIN BODY: Immuno...
Kappos, Ludwig Traboulsee, Anthony Li, David Bar-Or, Amit Barkhof, Frederik Montalban, Xavier Leppert, David Baldinotti, Anna Schneble, Hans-Martin Koendgen, Harold
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Open-label extension (OLE) studies help inform long-term safety and efficacy of disease-modifying therapies in multiple sclerosis (MS). We report exploratory analyses from a phase 2 trial on the longest follow-up to date of ocrelizumab-treated patients with relapsing-remitting MS (RRMS). The primary treatment period (PTP) comprised four 24-week tre...
Britten, Karissa McAndrew, Nicholas
Purpose of reviewIn recent years, there has been a flurry of activity in the human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer space. New, powerful drugs like trastuzumab deruxtecan have challenged our fundamental definition of what HER2 expression means as a predictive biomarker.Recent findingsRecent approvals of mu...
Rosenthal, Blake Aulakh, Sabreen Patel, Perseus Wong, Jason Ali, Sabina
PURPOSE: Biosimilar tumor necrosis factor inhibitors (b-TNFi) reduce healthcare costs and maintain equal efficacy when compared to their originator counterparts (o-TNFi). Current practice is to start patients on a slower standard infusion rate during the initial transition from an o-TNFi to a b-TNFi. There is a knowledge gap around switching from r...
Lorig-Roach, Nicholas Harpell, Nina M DuBois, Rebecca M
The clinical success of immune checkpoint inhibitors has underscored the key role of the immune system in controlling cancer. Current FDA-approved immune checkpoint inhibitors target the regulatory receptor pathways of cytotoxic T-cells to enhance their anticancer responses. Despite an abundance of evidence that natural killer (NK) cells can also m...
Sperling, R Donohue, M Rissman, R Johnson, K Rentz, D Grill, J Heidebrink, J Jenkins, C Jimenez-Maggiora, G Langford, O
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BACKGROUND: Converging evidence suggests that markers of Alzheimers disease (AD) pathology in cognitively unimpaired older individuals are associated with high risk of cognitive decline and progression to functional impairment. The Anti-Amyloid Treatment in Asymptomatic Alzheimers disease (A4) and Longitudinal Evaluation of Amyloid and Neurodegener...