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Necitumumab

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https://www.readbyqxmd.com/read/29108919/egfr-immunohistochemistry-as-biomarker-for-antibody-based-therapy-of-squamous-nsclc-experience-from-the-first-ring-trial-of-the-german-quality-assurance-initiative-for-pathology-quip-%C3%A2
#1
Iver Petersen, Manfred Dietel, Wolf J Geilenkeuser, Masoud Mireskandari, Wilko Weichert, Katja Steiger, Andreas H Scheel, Reinhard Büttner, Peter Schirmacher, Arne Warth, Felix Lasitschka, Hans-Ulrich Schildhaus, Thomas Kirchner, Simone Reu, Hans Kreipe, Florian Länger, Markus Tiemann, Christoph Schulte, Korinna Jöhrens
BACKGROUND: EGFR and its downstream signaling pathway are important targets for cancer therapy. Recently, the monoclonal anti-EGFR antibody Necitumumab in combination with gemcitabine and cisplatin was approved (EMA/14106/2016) for first-line treatment of squamous non-small cell carcinoma (SqNSCLC). Eligibility was restricted to cases with positive EGFR expression. In this context, a ring trial of the Quality Assurance Initiative for Pathology (QuIP(®)) was launched to prepare the German pathology community for a reliable and reproducible, immunohistochemically based biomarker test...
September 28, 2017: Pathology, Research and Practice
https://www.readbyqxmd.com/read/28675660/meta-analysis-of-first-line-therapies-with-maintenance-regimens-for-advanced-non-small-cell-lung-cancer-nsclc-in-molecularly-and-clinically-selected-populations
#2
Pui San Tan, Marcel Bilger, Gilberto de Lima Lopes, Sanchalika Acharyya, Benjamin Haaland
Evidence has suggested survival benefits of maintenance for advanced NSCLC patients not progressing after first-line chemotherapy. Additionally, particular first-line targeted therapies have shown survival improvements in selected populations. Optimal first-line and maintenance therapies remain unclear. Here, currently available evidence was synthesized to elucidate optimal first-line and maintenance therapy within patient groups. Literature was searched for randomized trials evaluating first-line and maintenance regimens in advanced NSCLC patients...
August 2017: Cancer Medicine
https://www.readbyqxmd.com/read/28569042/exposure-response-analysis-of-necitumumab-efficacy-in-squamous-non-small-cell-lung-cancer-patients
#3
E Chigutsa, A J Long, J E Wallin
We sought to describe the exposure-response relationship of necitumumab efficacy in squamous non-small cell lung cancer patients and evaluate intrinsic and extrinsic patient descriptors that may guide dosing. SQUIRE was a phase III study comparing necitumumab in combination with gemcitabine and cisplatin vs. gemcitabine and cisplatin alone in 1,014 patients. An integrated model for tumor size dynamics and overall survival was developed, where reduction in tumor size results in a decrease in survival hazard...
August 2017: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/28365238/an-open-label-randomized-controlled-phase-ii-study-of-paclitaxel-carboplatin-chemotherapy-with-necitumumab-versus-paclitaxel-carboplatin-alone-in-first-line-treatment-of-patients-with-stage-iv-squamous-non-small-cell-lung-cancer
#4
David R Spigel, Alexander Luft, Henrik Depenbrock, Rodryg Ramlau, Mazen Khalil, Joo-Hang Kim, Carlos Mayo, Grace Yi Chao, Coleman Obasaju, Ronald Natale
BACKGROUND: The combination of necitumumab with gemcitabine-cisplatin significantly improved overall survival (OS) in patients with stage IV squamous non-small-cell lung cancer (NSCLC), in the phase III SQUamous NSCLC treatment with the Inhibitor of EGF REceptor (SQUIRE) trial. Paclitaxel-carboplatin was selected as an alternative standard of care in the current phase II study. PATIENTS AND METHODS: Patients were randomized (stratified according to Eastern Cooperative Oncology Group performance status and sex) 2:1 to ≤ six 3-week cycles (Q3W) of paclitaxel and carboplatin with or without necitumumab...
March 2, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28356978/reproducibility-of-the-egfr-immunohistochemistry-scores-for-tumor-samples-from-patients-with-advanced-non-small-cell-lung-cancer
#5
Alejandro Avilés-Salas, Saé Muñiz-Hernández, Héctor Aquiles Maldonado-Martínez, José G Chanona-Vilchis, Laura-Alejandra Ramírez-Tirado, Norma HernáNdez-Pedro, Rita Dorantes-Heredia, José Manuel RuíZ-Morales, Daniel Motola-Kuba, Oscar Arrieta
Epidermal growth factor receptor (EGFR) is overexpressed in >60% of non-small cell lung cancer (NSCLC) cases. In combination with radiotherapy or chemotherapy, first-line treatments with antibodies against EGFR, including cetuximab and necitumumab, have demonstrated benefits by increasing overall survival (OS), particularly in patients who overexpress EGFR. The present study evaluated the interobserver agreement among three senior pathologists, who were blinded to the clinical outcomes and assessed tumor samples from 85 patients with NSCLC using the H-score method...
February 2017: Oncology Letters
https://www.readbyqxmd.com/read/28293124/spotlight-on-necitumumab-in-the-treatment-of-non-small-cell-lung-carcinoma
#6
REVIEW
Manish K Thakur, Antoinette J Wozniak
The treatment options for metastatic non-small-cell lung cancer (NSCLC) have expanded dramatically in the last 10 years with the discovery of newer drugs and targeted therapy. Epidermal growth factor receptor (EGFR), when aberrantly activated, promotes cell growth and contributes in various ways to the malignant process. EGFR has become an important therapeutic target in a variety of malignancies. Small-molecule tyrosine kinase inhibitors (TKIs) of EGFR are being used to treat advanced NSCLC and are particularly effective in the presence of EGFR mutations...
2017: Lung Cancer: Targets and Therapy
https://www.readbyqxmd.com/read/28277882/investigational-therapies-for-squamous-cell-lung-cancer-from-animal-studies-to-phase-ii-trials
#7
REVIEW
Elaine Shum, Feng Wang, Salem Kim, Roman Perez-Soler, Haiying Cheng
It remains challenging to treat squamous cell lung cancer (SCC) with limited therapeutic options. However, recent breakthroughs in targeted therapies and immunotherapies have shed some light on the management of this deadly disease. Areas covered: The article first reviews the current treatment options for advanced SCC, especially recent FDA approved molecular agents (afatinib, ramucirumab and necitumumab) and immunotherapies (nivolumab, pembrolizumab and atezolimumab). We then provide an overview on investigational therapies with data ranging from preclinical to phase II studies, focusing on new cytotoxic agents, emerging molecularly targeted agents (including a PARP inhibitor for Homologous Recombinant Deficiency positive SCC) and novel immunotherapeutic strategies...
April 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28111429/efficacy-and-safety-of-first-line-necitumumab-plus-gemcitabine-and-cisplatin-versus-gemcitabine-and-cisplatin-in-east-asian-patients-with-stage-iv-squamous-non-small-cell-lung-cancer-a-subgroup-analysis-of-the-phase-3-open-label-randomized-squire-study
#8
Keunchil Park, Eun Kyung Cho, Maximino Bello, Myung-Ju Ahn, Sumitra Thongprasert, Eun-Kee Song, Victoria Soldatenkova, Henrik Depenbrock, Tarun Puri, Mauro Orlando
PURPOSE: The phase 3 randomized SQUIRE study revealed significantly longer overall survival (OS) and progression-free survival (PFS) for necitumumab plus gemcitabine and cisplatin (neci+GC) than for gemcitabine and cisplatin alone (GC) in 1,093 patients with previously untreated advanced squamous non-small cell lung cancer (NSCLC). This post hoc subgroup analysis assessed the efficacy and safety of neci+GC among East Asian (EA) patients enrolled in the study. MATERIALS AND METHODS: All patients received up to six 3-week cycles of gemcitabine (days 1 and 8, 1,250 mg/m²) and cisplatin (day 1, 75 mg/m²)...
October 2017: Cancer Research and Treatment: Official Journal of Korean Cancer Association
https://www.readbyqxmd.com/read/27972596/the-effect-of-necitumumab-in-combination-with-gemcitabine-cisplatin-on-health-related-quality-of-life-hrqol-and-tolerability-squire-trial-patients-with-epidermal-growth-factor-receptor-egfr-expressing-squamous-nsclc-tumours
#9
M Reck, M Socinski, A Szczesna, M Dediu, R Ramlau, G Losonczy, O Molinier, C Schumann, J Brown, Soldatenkova, N Chouaki, N Thatcher, A Luft
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27913776/necitumumab-for-the-treatment-of-squamous-cell-non-small-cell-lung-cancer
#10
Jessica K Brinkmeyer, Donald C Moore
Non-small cell lung cancer is the most common form of lung cancer, accounting for about 85% of all cases and is further subdivided into adenocarcinoma, squamous cell, and large cell carcinoma. Necitumumab (Portrazza™, Eli Lilly and Company) is an anti-epidermal growth factor receptor monoclonal antibody approved for the first-line treatment of squamous cell non-small cell lung cancer in combination with cisplatin and gemcitabine. The safety and efficacy of necitumumab has been evaluated in two-phase III clinical trials, one demonstrating a lack of efficacy in non-squamous non-small cell lung cancer and another demonstrating improvement in overall survival and progression-free survival in squamous cell non-small cell lung cancer...
December 2, 2016: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/27912834/first-line-systemic-therapy-for-non-small-cell-lung-cancer
#11
REVIEW
Rebecca S Heist
Major advances in the treatment of metastatic non-small cell lung cancer have led to significant incremental improvements in patient outcomes. Platinum-based combination therapy remains the cornerstone of first-line therapy. The addition of biologic agents, such as bevacizumab or necitumumab, in selected populations has shown benefit over chemotherapy alone. The advent of maintenance therapy has also improved overall survival outcomes in selected populations of patients. Ongoing studies will further refine optimal treatment in the first-line setting and further advance first-line treatment options...
February 2017: Hematology/oncology Clinics of North America
https://www.readbyqxmd.com/read/27729681/cangrelor
#12
EDITORIAL
Danial E Baker, Kyle T Ingram
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line...
November 2015: Hospital Pharmacy
https://www.readbyqxmd.com/read/27696220/population-pharmacokinetics-of-necitumumab-in-cancer-patients
#13
Amanda Long, Emmanuel Chigutsa, Johan Wallin
Necitumumab is a second-generation, recombinant, human immunoglobulin G1, epidermal growth factor (EGFR) receptor antibody that specifically blocks the ligand binding site of EGFR. Necitumumab potentially acts by blocking ligand epidermal growth factor (EGF) binding-mediated activation of the EGFR signaling pathway, inhibiting tumor growth, angiogenesis, and anti-apoptotic mechanisms. Necitumumab inhibited the interaction of EGF and EGFR with a concentration that inhibits binding by 50 % of approximately 0...
May 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27692477/nice-guidance-on-necitumumab-for-untreated-advanced-or-metastatic-squamous-non-small-cell-lung-cancer
#14
Nwamaka Umeweni, Helen Knight, Gary McVeigh
No abstract text is available yet for this article.
November 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27668058/portrazza-necitumumab-an-igg1-monoclonal-antibody-fda-approved-for-advanced-squamous-non-small-cell-lung-cancer
#15
Loretta Fala
No abstract text is available yet for this article.
March 2016: American Health & Drug Benefits
https://www.readbyqxmd.com/read/27628194/phase-i-study-of-the-second-generation-recombinant-human-egfr-antibody-necitumumab-in-japanese-patients-with-advanced-solid-tumors
#16
Yosuke Tamura, Hiroshi Nokihara, Kazunori Honda, Yuko Tanabe, Hajime Asahina, Yasuhide Yamada, Sotaro Enatsu, Raffael Kurek, Noboru Yamamoto, Tomohide Tamura
PURPOSE: To establish the safety and pharmacokinetic profile of necitumumab in Japanese patients with advanced solid tumors not responsive to standard therapy or for which no standard therapy was available. METHODS: In this phase I study, patients aged ≥20 years with advanced solid tumors, and an Eastern Cooperative Oncology Group performance statuses of 0-1 were enrolled in a 3 + 3 design, with dose-escalation based on dose-limiting toxicity (DLT). Planned dose levels were: cohort 1: 600 mg IV, days 1 and 8, every 3 weeks; cohort 2: 800 mg IV, day 1, every 2 weeks; and cohort 3: 800 mg IV, days 1 and 8, every 3 weeks...
November 2016: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/27621656/clinical-potential-of-necitumumab-in-non-small-cell-lung-carcinoma
#17
REVIEW
Carlo Genova, Fred R Hirsch
Despite significant progress, new therapeutic approaches for advanced non-small cell lung cancer (NSCLC) are highly needed, particularly for the treatment of patients with squamous cell carcinoma. The epidermal growth factor receptor (EGFR) is often overexpressed in NSCLC and represents a relevant target for specific treatments. Although EGFR mutations are more frequent in non-squamous histology, the receptor itself is more often overexpressed in squamous NSCLC. Necitumumab is a human monoclonal antibody that is able to inhibit the EGFR pathway and cause antibody-dependent cell cytotoxicity...
2016: OncoTargets and Therapy
https://www.readbyqxmd.com/read/27614872/necitumumab-plus-gemcitabine-and-cisplatin-as-first-line-therapy-in-patients-with-stage-iv-egfr-expressing-squamous-non-small-cell-lung-cancer-german-subgroup-data-from-an-open-label-randomized-controlled-phase-3-study-squire
#18
RANDOMIZED CONTROLLED TRIAL
Martin Reck, Michael Thomas, Cornelia Kropf-Sanchen, Jörg Mezger, Mark A Socinski, Henrik Depenbrock, Victoria Soldatenkova, Jacqueline Brown, Thomas Krause, Nick Thatcher
BACKGROUND: In the SQUIRE study, adding the anti-epidermal growth factor receptor (EGFR) IgG1 antibody necitumumab to first-line gemcitabine and cisplatin (GC + N) in advanced squamous non-small-cell lung cancer (sqNSCLC) significantly improved overall survival (OS); the safety profile was acceptable. We explored data for the German subpopulation (N = 96) of SQUIRE patients with EGFR-expressing tumors. PATIENT AND METHODS: Patients with stage IV sqNSCLC were randomized 1:1 to up to 6 cycles of open-label GC + N or GC alone...
2016: Oncology Research and Treatment
https://www.readbyqxmd.com/read/27575423/incremental-innovation-and-progress-in-advanced-squamous-cell-lung-cancer-current-status-and-future-impact-of-treatment
#19
REVIEW
Corey J Langer, Coleman Obasaju, Paul Bunn, Philip Bonomi, David Gandara, Fred R Hirsch, Edward S Kim, Ronald B Natale, Silvia Novello, Luis Paz-Ares, Maurice Pérol, Martin Reck, Suresh S Ramalingam, Craig H Reynolds, Mark A Socinski, David R Spigel, Heather Wakelee, Carlos Mayo, Nick Thatcher
Squamous cell lung cancer (sqCLC) is an aggressive form of cancer that poses many therapeutic challenges. Patients tend to be older, present at a later stage, and have a high incidence of comorbidities, which can compromise treatment delivery and exacerbate toxicity. In addition, certain agents routinely available for nonsquamous cell histologic subtypes, such as bevacizumab and pemetrexed, are contraindicated or lack efficacy in sqCLC. Therapeutic progress has been much slower for advanced sqCLC, with median survival times of approximately 9 to 11 months in most studies...
December 2016: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27535394/targeted-therapies-for-lung-cancer
#20
REVIEW
Thomas E Stinchcombe
Targeted therapies have become standard therapies for patients with non-small cell lung cancer (NSCLC). A phase III trial of carboplatin and paclitaxel with and without bevacizumab in patients with advanced NSCLC with non-squamous histology demonstrated a statistically significant improvement in efficacy. In patients with NSCLC with an activating epidermal growth factor receptor (EGFR) mutation (defined as exon 19 deletion and exon 21 L858R point mutation), phase III trials of EGFR tyrosine kinase inhibitors (TKI) compared to platinum-based chemotherapy have demonstrated superior efficacy in the first-line setting...
2016: Cancer Treatment and Research
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