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Latest & greatest articles for lung cancer
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Erlotinib plus bevacizumab versus erlotinib alone in patients with EGFR-positive advanced non-squamous non-small-cell lungcancer (NEJ026): interim analysis of an open-label, randomised, multicentre, phase 3 trial Resistance to first-generation or second-generation EGFR tyrosine kinase inhibitor (TKI) monotherapy develops in almost half of patients with EGFR-positive non-small-cell lungcancer (NSCLC) after 1 year of treatment. The JO25567 phase 2 trial comparing erlotinib plus bevacizumab (...) with activating EGFR genomic aberrations from 69 centres across Japan. Eligible patients were at least 20 years old, and had an Eastern Cooperative Oncology Group performance status of 2 or lower, no previous chemotherapy for advanced disease, and one or more measurable lesions based on Response Evaluation Criteria in Solid Tumours (1.1). Patients were randomly assigned (1:1) to receive oral erlotinib 150 mg per day plus intravenous bevacizumab 15 mg/kg once every 21 days, or erlotinib 150 mg per day
in this indication has been considered by SMC using its decision-making framework for the assessment of ultra-orphan medicines. Nature of condition ALK-positive NSCLC is a rare form of lungcancer with ALK gene rearrangements occurring in approximately 5% of patients with NSCLC. ALK-positive disease is more common in younger patients, with adenocarcinoma histology who have never smoked. 2, 3 Until recently, crizotinib has been the standard first-line treatment of ALK-positive NSCLC and although it is effective (...) in ALK -rearranged non-small-cell lungcancer and other malignancies: a single-arm, open-label, phase 1/2 trial. The Lancet Oncology. 2016;17(12):1683-96. 10. Planchard D, Popat S, Kerr K, Novello S, Smit EF, Faivre-Finn C, et al. Metastatic non- small cell lungcancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow- up. Annals of oncology : official journal of the European Society for Medical Oncology. 2018;29(Supplement_4):iv192-iv237. Epub 2018/10/05. 11. Scottish
considered under the ultra-orphan and end of life process durvalumab (Imfinzi®) is accepted for use within NHSScotland. Indication under review: as monotherapy for the treatment of locally advanced, unresectable non-small cell lungcancer (NSCLC) in adults whose tumours express PD-L1 [programmed cell death ligand 1] on =1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy. Durvalumab, compared with placebo, improved progression-free survival and overall (...) and Clinician Engagement (PACE) meeting. Chairman Scottish Medicines Consortium www.scottishmedicines.org.uk 2 Indication As monotherapy for the treatment of locally advanced, unresectable non-small cell lungcancer (NSCLC) in adults whose tumours express PD-L1 [programmed cell death ligand 1] on = 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy. 1 Dosing Information Durvalumab 10mg/kg intravenous (IV) infusion over 60 minutes every 2 weeks, until
Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lungcancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. First-line pembrolizumab monotherapy improves overall and progression-free survival in patients with untreated metastatic non-small-cell lungcancer with a programmed death ligand 1 (PD-L1) tumour proportion score (TPS) of 50% or greater. We investigated overall survival after treatment (...) with pembrolizumab monotherapy in patients with a PD-L1 TPS of 1% or greater.This randomised, open-label, phase 3 study was done in 213 medical centres in 32 countries. Eligible patients were adults (≥18 years) with previously untreated locally advanced or metastatic non-small-cell lungcancer without a sensitising EGFR mutation or ALK translocation and with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, life expectancy 3 months or longer, and a PD-L1 TPS of 1% or greater
2019LancetControlled trial quality: predicted high
authorisation indication indication Durvalumab (Imfinzi, AstraZeneca) is indicated 'as monotherapy for the treatment of locally advanced, unresectable non-small-cell lungcancer in adults whose tumours express PD-L1 on =1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation' . Dosage in Dosage in the the mark marketing eting authorisation authorisation 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks, until disease progression (...) There is an unmet need for treatment options in this disease area 3.1 Locally advanced unresectable non-small-cell lungcancer (NSCLC) is a highly heterogeneous disease with complex symptoms. Durvalumab is indicated for use in people whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed after chemoradiation. At this stage, durvalumab has the potential to be curative. The patient expert explained that Durvalumab for treating locally advanced unresectable non-small-cell
Association of Patient Characteristics and Tumor Genomics With Clinical Outcomes Among Patients With Non-Small Cell LungCancer Using a Clinicogenomic Database. Data sets linking comprehensive genomic profiling (CGP) to clinical outcomes may accelerate precision medicine.To assess whether a database that combines EHR-derived clinical data with CGP can identify and extend associations in non-small cell lungcancer (NSCLC).Clinical data from EHRs were linked with CGP results for 28 998 patients (...) EHRs.Overall survival (OS), time receiving therapy, maximal therapy response (as documented by the treating physician in the EHR), and clinical benefit rate (fraction of patients with stable disease, partial response, or complete response) to therapy.Among 4064 patients with NSCLC (median age, 66.0 years; 51.9% female), 3183 (78.3%) had a history of smoking, 3153 (77.6%) had nonsquamous cancer, and 871 (21.4%) had an alteration in EGFR, ALK, or ROS1 (701 [17.2%] with EGFR, 128 [3.1%] with ALK, and 42 [1.0
Gibbert ? Thomas Kaiser ? Inga Overesch ? Cornelia Rüdig ? Anke Schulz Keywords: alectinib, carcinoma – non-small-cell lung, benefit assessment, NCT02075840 Extract of dossier assessment A17-67 Version 1.0 Alectinib (non-small cell lungcancer) 28 March 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - iii - Table of contents Page List of tables iv List of abbreviations v 2 Benefit assessment 1 2.1 Executive summary of the benefit assessment 1 2.2 Research question 6 2.3 Information (...) -free survival QLQ-C30 Quality of Life Questionnaire-Core 30 QLQ-LC13 Questionnaire-LungCancer 13 RCT randomized controlled trial RECIST Response Evaluation Criteria in Solid Tumours SAE serious adverse event SGB Sozialgesetzbuch (Social Code Book) SPC Summary of Product Characteristics VAS visual analogue scale Extract of dossier assessment A17-67 Version 1.0 Alectinib (non-small cell lungcancer) 28 March 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - 2 Benefit assessment
Alectinib (non-small-cell lungcancer) - Addendum to Commission A17-67 1 Translation of addendum A18-30 Alectinib (nicht kleinzelliges Lungenkarzinom) – Addendum zum Auftrag A17-67 (Version 1.0; Status: 1 June 2018). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 1 June 2018 1.0 Commission: A18-30 Version: Status: IQWiG Reports – Commission No. A18-30 (...) Alectinib (non-small cell lungcancer) – Addendum to Commission A17-67 1 Addendum A18-30 Version 1.0 Alectinib – Addendum to Commission A17-67 1 June 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Alectinib (non-small cell lungcancer) – Addendum to Commission A17-67 Commissioning agency: Federal Joint Committee Commission awarded on: 8 May 2018 Internal Commission No.: A18-30 Address
OAK and POPLAR. Both studies investigated the comparison of atezolizumab versus docetaxel in adult patients with locally advanced or metastatic non-small cell lungcancer (NSCLC) with disease progression during or after platinum-based chemotherapy for advanced disease. Both studies were therefore relevant for research question 1 of dossier assessment A17-50 on atezolizumab (patients for whom treatment with docetaxel, pemetrexed or nivolumab is indicated ). However, the data presented (...) Association for the Study of LungCancer; IC: immune cells; NSCLC: non-small cell lungcancer; PD-L1: programmed cell death ligand 1; TC: tumour cells; UICC: Union for International Cancer Control The G-BA decides on the added benefit. Addendum A18-09 Version 1.0 Atezolizumab – Addendum to Commission A17-50 23 February 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - 8 - 4 References 1. Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Atezolizumab (nicht kleinzelliges
Updated Analysis of KEYNOTE-024: Pembrolizumab Versus Platinum-Based Chemotherapy for Advanced Non-Small-Cell LungCancer With PD-L1 Tumor Proportion Score of 50% or Greater In the randomized, open-label, phase III KEYNOTE-024 study, pembrolizumab significantly improved progression-free survival and overall survival (OS) compared with platinum-based chemotherapy in patients with previously untreated advanced non-small-cell lungcancer (NSCLC) with a programmed death ligand 1 tumor proportion
Crizotinib (Alunbrig) - for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lungcancer (NSCLC) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization