Summary of recent research progress in the field of cancer (04.09) April 09, 2018 Source: WuXi PharmaTech 1. It is expected to treat lung cancer in the first line, and Pfizer's new drug will be given priority for evaluation. Pfizer recently announced that the US FDA has accepted a new drug application (NDA) for its new lung cancer drug dacomitinib and has been granted priority review. This human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) is expected to be the first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR activating mutations. In addition, the European Medicines Agency (EMA) has accepted dacomitinib's marketing authorization application (MAA) for the same indications. Lung cancer is the leading cause of cancer deaths worldwide, with NSCLC accounting for about 85% of lung cancer cases and still difficult to treat today. Approximately 75% of NSCLC patients are diagnosed at an advanced stage with a five-year survival rate of only 5%. EGFR is a protein that helps cells grow and divide, and when it mutates, it promotes cancer cell proliferation. EGFR mutations occur in 10% to 35% of NSCLC worldwide. The dacomitinib brought by Pfizer belongs to the “second generation EGFR TKIâ€. Compared with the first generation of drugs, its binding to EGFR is more effective, so it is expected to achieve more significant inhibition. The new drug application is based on the results of the global Phase 3 clinical trial ARCHER1050, which compared dacomitinib (n=227) with gefitinib (n=225) in the treatment of locally advanced or metastatic with EGFR activating mutations. The efficacy of NSCLC patients. Median progression-free survival (PFS) was 14.7 months in patients receiving dacomitinib, compared with 9.2 months in the control group, according to a blinded independent center review. This difference suggests that dacomitinib as a first-line therapy can reduce the risk of disease progression or death in patients by 41% (HR=0.59 [95% CI: 0.47, 0.74], p<0.0001). The adverse events observed in the study were consistent with the results of previous trials. "Although the treatment of patients with non-small cell lung cancer with EGFR activating mutations has made significant progress, it remains a challenging disease requiring new treatment options," said Dr. Mace Rothenberg, Pfizer's chief development officer for global product development oncology. "In a critical clinical trial, dacomitinib showed clinically significant improvement over the first class of EGFR-targeted drugs in progression-free survival. These reports are for the treatment of patients with locally advanced or metastatic EGFR mutations in non-small cell lung cancer. An important step in the program." 2. Good effect on a variety of cancers, Lilly new drugs harvest positive clinical results Recently, Eli Lilly and Company announced the positive top-line data of REACH-2, a clinical phase 3 study of Cyramza (ramucirumab) as a monotherapy for second-line treatment of hepatocellular carcinoma (HCC). To date, Cyramza has shown survival benefits for four invasive, refractory tumor types in Phase 3 clinical studies, including monotherapy as a gastric cancer and HCC. HCC is the most common type of liver cancer and the third-ranked cancer killer, affecting 500,000 people worldwide, with the highest incidence in Asia and Africa. About half of patients with advanced HCC have high levels of alpha-fetoprotein (AFP), a protein produced during early fetal development, also produced from the liver and various tumors (including HCC). The prognosis of such patients is often poor. Cyramza is a fully human monoclonal antibody to vascular endothelial growth factor receptor 2 (VEGFR2) that binds to and blocks the activation of VEGFR2. Previously, the drug has been approved in the United States and Europe for the treatment of gastric or gastroesophageal adenocarcinoma with no chemotherapy or chemotherapy, and non-small cell lung cancer. Cyramza is currently evaluating the efficacy of more than 12,000 patients in more than 708 clinical trials worldwide, in addition to being a monotherapy, in combination with other anticancer therapies to study the efficacy of multiple tumor types. The current REACH-2 is a global, randomized, double-blind, placebo-controlled phase 3 clinical trial comparing Cyramza and placebo in disease progression to or intolerance to sorafenib. Efficacy of AFP serum levels (≥400 ng/mL, primary liver cancer-specific markers) in liver cancer patients. The trial began in 2015 with a total of 292 patients enrolled in 20 countries around the world, the first phase 3 HCC trial in a population of patients classified by biomarker testing. The results showed that the study reached the primary end point of overall survival (OS), and the secondary endpoint of progression-free survival (PFS), and the safety data was consistent with previous results. Dr. Levi Garraway, senior vice president of global development and medical affairs at Lilly's Cancer, said in a statement: "Advanced liver cancer is an invasive disease with a poor prognosis, and for patients with elevated AFP levels, the prognosis is even more Oops. If there is no second-line treatment, the expected survival of these patients after first-line treatment is only a few months. Because of this, Eli Lilly's results on REACH-2 and Cyramza's potential to benefit patients in this situation Inspired." 3. AstraZeneca leukemia new drug is granted priority review Recently, AstraZeneca and its global biologics research and development department, MedImmune, announced that the US FDA has accepted the new drug moxetumomab pasudotox biologics license application (BLA), which is a research anti-CD22 recombinant immunotoxin, which can be used Treatment of adult patients with hairy cell leukemia (HCL) who have received at least two treatments. The FDA also grants the application priority review. Hairy cell leukemia (HCL) is a rare, slow-growing, incurable leukemia in which the patient's bone marrow overproduces abnormal B cells or lymphocytes. HCL can cause serious and even life-threatening diseases such as infection, bleeding and anemia. About 1,000 people in the United States are diagnosed with HCL each year. Although many patients initially respond to treatment, up to 40% of patients will relapse. Patients with relapsed or refractory HCL still have significant unmet medical needs due to the absence of established standard treatment options and minimal treatment. Moxetumomab pasudotox (formerly known as CAT-8015 or HA22) is an anti-CD22 recombinant immunotoxin that is expected to be the treatment of choice for this type of patient. Immunotoxins combine the selectivity of antibodies for targeted drug delivery with the efficacy of toxins to kill cancer cells. The drug consists of a binding moiety of an anti-CD22 antibody fused to a toxin. CD22 is a B lymphocyte-restricted transmembrane protein that has a higher receptor density in HCL cells than normal B cells, making it an attractive target for the treatment of this type of cancer. Upon binding to CD22, the molecule is internalized, treated and releases the modified protein toxin, inhibiting translation of the protein, leading to apoptosis. It is worth mentioning that moxetumomab pasudotox has been granted orphan drug status by the FDA to treat HCL. The efficacy and safety of this drug has also been validated in clinical trials. Phase 3 clinical trial 1053 reached the primary endpoint of sustained complete remission in adult patients with relapsed or refractory HCL, and specific results will be announced at an upcoming medical conference. 4. For all solid tumors, the first genome-wide spectrum test was officially launched Foundation Medicine recently announced that FoundationOne CDxTM, the first FDA-approved genome-wide profiling (CGP) test for multiple solid tumor companion diagnostics, is now available in the United States. Expanding access to clinical and analytically validated genomic analyses can lead to ways to improve patient outcomes. Individualized treatments based on biomarkers have been shown to be associated with the clinical benefit of tumor types and biomarkers, making treatment options more complex. The FoundationOne CDx provides a comprehensive platform for all solid tumors to detect changes in specific genomes, helping to guide effective individualized treatment decisions while reducing the time and organization required to test biomarkers. FoundationOne CDx is an FDA-approved CGP assay for all solid tumors, assessing 324 genome changes known to promote cancer growth genes, providing potentially useful information and guiding treatment options. FoundationOne CDx is also approved by the FDA as a broad companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those that may be targeted from 17 tags. Among the patients who benefited from the treatment, 12 were first-line treatments for approved indications. FoundationOne CDx also reports genomic biomarkers such as microsatellite instability (MSI) and tumor mutation load (TMB), which will help in the selection of immunotherapies. In addition, it provides additional genomic alterations related to patient management, as well as relevant clinical trial information. Therefore, it is designed to help simplify the development of companion diagnostics, reduce risk and advance targeted therapeutic development. In all of these ways, FoundationOne CDx can be used as an FDA-approved clinical research platform for biopharmaceutical companies, or as a CGP platform to help biopharmaceutical companies develop companion diagnostics for their precision medicine. â–² Dr. Vincent Miller, Chief Medical Officer of Foundation Medicine (Source: Foundation Medicine Official Website) “FoundationOne CDx is now widely available in the United States, and oncologists are beginning to use this valuable test to help guide and streamline individualized treatment decisions for patients,†said Dr. Vincent Miller, Chief Medical Officer of Foundation Medicine. “By integrating EarlyOne's FoundationOne CDx into routine clinical care, oncologists can improve treatment efficiency and expand patients' access to biomarker-driven drugs to improve treatment outcomes.†Reference material [1] Riding a wave of positive PhIII readouts, Pfizer gets a snap review for lung cancer drug dacomitinib [2] Eli Lilly's Cyramza Succeeds in Phase III Trial [3] US FDA accepts Biologics License Application for moxetumomab pasudotox in hairy cell leukaemia [4] Foundation Medicine Announces Commercial Availability of FoundationOne CDxTM, the First FDA-Approved Comprehensive Genomic Profiling Assay for All Solid Tumors Incorporating Multiple Companion Diagnostics Original title: Summary of recent research progress in the field of cancer (No. 61)
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