On April 6, 2016 AstraZeneca reported that it will report new clinical trial and scientific data from their industry-leading lung cancer franchise of marketed and pipeline medicines at the European Lung Cancer Conference (ELCC) together with its global biologics research and development arm, MedImmune, in Geneva, Switzerland, 13 -16 April, 2016 (Press release, AstraZeneca, APR 6, 2016, View Source [SID:1234510436]). Schedule your 30 min Free 1stOncology Demo! Fifteen abstracts will be presented at the meeting including eight oral presentations, two "best abstracts" and two "late-breakers". Five abstracts have been selected for the official press programme. Highlights will reinforce the potential of Tagrisso (osimertinib) for the treatment of specific types of advanced non-small cell lung cancer (NSCLC), compare plasma testing and tumour tissue biopsy for treatment decisions in advanced NSCLC, and demonstrate the progress of combination therapy in immuno-oncology.
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
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Tagrisso in first- and second-line lung cancer treatment
Two oral, late-breaker presentations share data from the Tagrisso AURA studies. They build on evidence that supported the accelerated approval of Tagrisso as the first indicated treatment for epidermal growth factor receptor (EGFR) T790M mutation-positive metastatic NSCLC in the US, EU and Japan.
On Thursday 14 April, updated efficacy and safety data will be presented from two Phase I expansion cohorts exploring Tagrisso as first-line treatment for patients with EGFRm advanced NSCLC (Abstract #LBA1_PR). Phase I/II data in pre-treated patients with EGFR T790M advanced NSCLC (Abstract #LBA2_PR) will also be presented. Both presentations will feature in the ELCC press programme on Thursday 14 April.
Mondher Mahjoubi, Senior Vice President, Head of Oncology, Global Product and Portfolio Strategy at AstraZeneca, said: "ELCC’s recognition of the importance of our data for the lung cancer community is very encouraging and we are excited to present more mature data from the AURA programme for our new, first-in-class lung cancer medicine, Tagrisso. We are also reaffirming our commitment to deliver the right treatment to the right patient based on scientific research, with updates from our pioneering plasma circulating tumour DNA trials."
Plasma ctDNA testing: Delivering the right treatment to the right patient
Accurate identification of patients with tumours carrying key molecular mutations is essential for delivering next-generation targeted therapies to those most likely to benefit. Detection of plasma circulating tumour-derived DNA (ctDNA) in a simple blood test offers a minimally invasive alternative to tumour tissue biopsy, and is already available for identifying patients suitable for treatment with AstraZeneca’s Iressa.
Building on this work, the latest results from innovative research in minimally invasive plasma ctDNA analysis to identify patients with EGFRm T790M NSCLC and predict response to Tagrisso will be reported (Abstract #134O_PR and #135O_PR). Further data from the ASSESS study for EGFR mutation detection in plasma from this patient group will also be presented (Abstract #58O_PR). ASSESS is the first largescale "real-world" study comparing tumour biopsy with ctDNA testing for EGFRm in advanced NSCLC. These studies are highlighted in the ELCC press programme on Friday 15 April.
Marc Denis, Professor of Biochemistry and Molecular Biology at Nantes University Hospital, Nantes, France, said: "Plasma ctDNA testing has the potential to rapidly identify patients suitable for targeted therapy not just for lung cancer but across a wide range of tumour types. Availability of these simple blood tests may streamline diagnosis, including for patients where tumour samples are unavailable."
Immuno-oncology (IO): Combination focus
AstraZeneca has a broad programme of combination clinical trials underway in oncology and continues to explore novel combination therapies addressing the needs of difficult-to-treat patients with lung cancer. Safety and efficacy data from two exploratory trials combining immunotherapies and small-molecules will be reported at ELCC. These presentations have been designated "best abstracts" (Abstracts #57O and #136O) by the conference.
Robert Iannone, Head of Immuno-Oncology, Global Medicines Development, at AstraZeneca, said: "Durvalumab is the cornerstone of our IO portfolio and we have a rapidly-advancing development programme focused primarily on novel combinations. At ELCC, we are presenting the exceptional science behind our combination approach with abstracts describing the ongoing MYSTIC and NEPTUNE studies combining durvalumab with tremelimumab. These build on recent data showing the anti-tumour activity of this combination in patients with metastatic NSCLC irrespective of PD-L1 status, as published in The Lancet Oncology."
Author: [email protected]
10-K/A [Amend] – Annual report [Section 13 and 15(d), not S-K Item 405]
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Ageing with elegans: a research proposal to map healthspan pathways.
Human longevity continues to increase world-wide, often accompanied by decreasing birth rates. As a larger fraction of the population thus gets older, the number of people suffering from disease or disability increases dramatically, presenting a major societal challenge. Healthy ageing has therefore been selected by EU policy makers as an important priority ( View Source ); it benefits not only the elderly but also their direct environment and broader society, as well as the economy. The theme of healthy ageing figures prominently in the Horizon 2020 programme ( View Source ), which has launched several research and innovation actions (RIA), like "Understanding health, ageing and disease: determinants, risk factors and pathways" in the work programme on "Personalising healthcare" ( View Source ). Here we present our research proposal entitled "ageing with elegans" (AwE) ( View Source ), funded by this RIA, which aims for better understanding of the factors causing health and disease in ageing, and to develop evidence-based prevention, diagnostic, therapeutic and other strategies. The aim of this article, authored by the principal investigators of the 17 collaborating teams, is to describe briefly the rationale, aims, strategies and work packages of AwE for the purposes of sharing our ideas and plans with the biogerontological community in order to invite scientific feedback, suggestions, and criticism.
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Comparison of a High-Throughput Mass Spectrometry Method and Radioactive Filter Binding to Assay the Protein Methyltransferase PRMT5.
Conformational remodeling of chromatin in cells is known to alter gene expression. The histone code hypothesis postulates that multiple modifications present on histone tails can regulate gene expression both through direct effects on chromatin compaction as well as through recruitment of unique complexes that signal specific downstream functions. Histone methylation is an important component of the histone code, and the dysregulation of histone methylation in disease makes methyltransferases and demethylases viable targets for drug discovery. We developed a biochemical assay platform, which takes advantage of the fact that protein methyltransferases (PMTs) all utilize the cofactor S-Adenosyl-L-methionine (SAM) as the methyl donor. The platform utilizes the High-throughput Mass Spectrometry (MS) technology to measure SAM and the S-Adenosyl-L-homocysteine product in a label-free manner. The platform has all the advantages of a label-free system coupled with the benefit of substrate agnostic measurements making it an ideal setup for PMT biochemical studies and drug discovery. In addition, MS is ideally suited for detecting multiple modification events within the same substrate. The ability to adjust the detection to monitor the methyl acceptor product allows for real-time measurements of multiple product species simultaneously, a distinct advantage over other commonly used assay formats.
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Economic Comparison of an Empirical Versus Diagnostic-Driven Strategy for Treating Invasive Fungal Disease in Immunocompromised Patients.
Patients with persistent or recurrent neutropenic fevers at risk of invasive fungal disease (IFD) are treated empirically with antifungal therapy (AFT). Early treatment using a diagnostic-driven (DD) strategy may reduce clinical and economic burdens. We compared costs and outcomes of both strategies from a UK perspective.
An empirical strategy with conventional amphotericin B deoxycholate (C-AmB), liposomal amphotericin B (L-AmB), or caspofungin was compared with a DD strategy (initiated based on positive ELISA results for galactomannan antigen) and/or positive results for Aspergillus species on polymerase chain reaction assay) using C-AmB, voriconazole, or L-AmB in a decision-analytic model. Rates of IFD incidence, overall mortality, and IFD-related mortality in adults expected to be neutropenic for ≥10 days were obtained. The empirical strategy was assumed to identify 30% of IFD and targeted AFT to improve survival by a hazard ratio of 0.589. AFT-specific adverse events were obtained from a summary of product characteristics. Resource use was obtained, and costs were estimated by using standard UK costing sources. All costs are presented in 2012 British pounds sterling.
Total costs were 32% lower for the DD strategy (£1561.29) versus the empirical strategy (£2301.93) due to a reduced incidence of adverse events and decreased use of AFT. Administration of AFT was reduced by 41% (DD strategy, 74 of 1000; empirical strategy, 125 of 1000), with similar survival rates.
This study suggests that a DD strategy is likely to be cost-saving versus empirical treatment for immunocompromised patients with persistent or recurrent neutropenic fevers.
Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.
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