Articles: human.
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The lancet oncology · Jul 2024
Multicenter StudyCombining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study.
Current systemic therapies for metastatic pancreatic ductal adenocarcinoma are associated with poor outcomes with a 5-year overall survival rate under 5%. We aimed to assess the safety and antitumour activity of mitazalimab, a human CD40 agonistic IgG1 antibody, with modified FOLFIRINOX (mFOLFIRINOX; fluorouracil, leucovorin, oxaliplatin, and irinotecan), in chemotherapy-naive patients with metastatic pancreatic ductal adenocarcinoma. ⋯ Alligator Bioscience.
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Observational Study
Initial Evidence of a Possible Effect of HPV Vaccination on Cancer Incidence in Germany—Focus on Cervical Cancer.
Infection with human papillomavirus (HPV) is one of the more common sexually transmitted diseases in Germany. Vaccination against HPV was introduced in Germany in 2007. In this study, we sought to detect a population-based decline in the incidence of cervical cancer in women under age 30 who were eligible for vaccination in the first 11 years after its introduction. ⋯ Eleven years after the introduction of HPV vaccination, a drop in the incidence of cervical cancer was observable at the population level in the birth cohorts eligible for vaccination.
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Randomized Controlled Trial Multicenter Study
Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation.
Dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation, has shown efficacy and safety in a phase 3 trial involving patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation and an elevated risk of exacerbation. Whether the findings would be confirmed in a second phase 3 trial was unclear. ⋯ In patients with COPD and type 2 inflammation as indicated by elevated blood eosinophil counts, dupilumab was associated with fewer exacerbations and better lung function than placebo. (Funded by Sanofi and Regeneron Pharmaceuticals; NOTUS ClinicalTrials.gov number, NCT04456673.).
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Chinese medical journal · Jun 2024
Population pharmacokinetics of Ainuovirine and exposure-response analysis in human immunodeficiency virus-infected individuals.
Ainuovirine (ANV) is a new generation of non-nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) type 1 infection. This study aimed to evaluate the population pharmacokinetic (PopPK) profile and exposure-response relationship of ANV among people living with HIV. ⋯ Our PopPK model supported ANV 150 mg once daily as the recommended dose for people living with HIV, requiring no dose adjustment for the studied factors. Optimization of ANV dose may be warranted in clinical practice due to an increasing trend in adverse reactions with increasing exposure.