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https://www.readbyqxmd.com/read/28092856/separation-of-antibody-drug-conjugate-species-by-rplc-a-generic-method-development-approach
#1
Szabolcs Fekete, Imre Molnár, Davy Guillarme
This study reports the use of modelling software for the successful method development of IgG1 cysteine conjugated antibody drug conjugate (ADC) in RPLC. The goal of such a method is to be able to calculate the average drug to antibody ratio (DAR) of and ADC product. A generic method development strategy was proposed including the optimization of mobile phase temperature, gradient profile and mobile phase ternary composition. For the first time, a 3D retention modelling was presented for large therapeutic protein...
January 11, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28088309/-new-therapy-outlooks-in-hodgkin-lymphoma
#2
REVIEW
Cédric Rossi, René-Olivier Casasnovas
Classical Hodgkin lymphoma (HL) is a curable disease in 80% of advanced and 90% of localized stages. An improvement of the HL curability is still possible with the emergence of first-line therapy with a better balance between efficacy and toxicity and early identification patients with high risk of failure requiring specific treatment. 18FDG PET-CT gained a major role in the baseline staging and response assessment to HL treatment. The prognostic value of early PET-CT allowed to develop PET-CT guided therapies able to optimize the balance between efficacy and toxicity including the modulation of the chemotherapy intensity or the omission of radiotherapy for some localized diseases...
January 11, 2017: Bulletin du Cancer
https://www.readbyqxmd.com/read/28073814/donor-derived-mycosis-fungoides-following-reduced-intensity-haematopoietic-stem-cell-transplantation-from-a-matched-unrelated-donor
#3
Francesca A M Kinsella, Mohammad Rasoul Amel Kashipaz, Julia Scarisbrick, Ram Malladi
A 46-year-old woman with a history of dasatinib-resistant chronic myeloid leukaemia, clonal evolution and monosomy 7 underwent reduced intensity conditioned in vivo T-cell-depleted allogeneic haematopoietic stem cell transplantation (HSCT) from a matched unrelated donor. Following the transplantation, she developed recurrent cutaneous graft versus host disease (GvHD), which required treatment with systemic immunosuppression and electrocorporeal photophoresis. Concurrently, she developed a lichenoid rash with granulomatous features suggestive of cutaneous sarcoidosis...
January 10, 2017: BMJ Case Reports
https://www.readbyqxmd.com/read/28065438/using-health-care-claims-data-to-assess-the-prevalence-of-hodgkin-lymphoma-and-relapsed-or-refractory-hodgkin-lymphoma-in-the-united-states
#4
Jay Lin, Lisa R Siegartel, Melissa Lingohr-Smith, Brandy Menges, Dinara Makenbaeva
PURPOSE: Although most patients with Hodgkin lymphoma (HL) respond to primary therapy, some patients experience relapses or are refractory to treatment (RR-HL). The objectives of this study were to investigate the prevalence of HL and RR-HL in the United States by using a large health care claims database. METHODS: Patients with ≥1 diagnosis for HL between January 1, 2013, and September 30, 2014 (prevalence assessment period), in the MarketScan Commercial and Medicare databases were identified...
January 5, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28062707/optimization-of-a-pegylated-glucuronide-monomethylauristatin-e-linker-for-antibody-drug-conjugates
#5
Patrick J Burke, Joseph Z Hamilton, Scott C Jeffrey, Joshua H Hunter, Svetlana O Doronina, Nicole M Okeley, Jamie B Miyamoto, Martha E Anderson, Ivan J Stone, Michelle L Ulrich, Jessica K Simmons, Erica E McKinney, Peter D Senter, Robert P Lyon
The emergence of antibody-drug conjugates (ADC), such as brentuximab vedotin and ado-trastuzumab emtansine, has led to increased efforts to identify new payloads and develop improved drug-linker technologies. Most antibody payloads impart significant hydrophobicity to the ADC, resulting in accelerated plasma clearance and suboptimal in vivo activity, particularly for conjugates with high drug-to-antibody ratios (DAR). We recently reported on the incorporation of a discrete PEG24 polymer as a side chain in a β-glucuronidase-cleavable monomethylauristatin E (MMAE) linker to provide homogeneous DAR 8 conjugates with decreased plasma clearance and increased antitumor activity in xenograft models relative to a non-PEGylated control...
January 2017: Molecular Cancer Therapeutics
https://www.readbyqxmd.com/read/28017562/optimization-of-non-linear-gradient-in-hydrophobic-interaction-chromatography-for-the-analytical-characterization-of-antibody-drug-conjugates
#6
Balázs Bobály, Giuseppe Marco Randazzo, Serge Rudaz, Davy Guillarme, Szabolcs Fekete
The goal of this work was to evaluate the potential of non-linear gradients in hydrophobic interaction chromatography (HIC), to improve the separation between the different homologous species (drug-to-antibody, DAR) of commercial antibody-drug conjugates (ADC). The selectivities between Brentuximab Vedotin species were measured using three different gradient profiles, namely linear, power function based and logarithmic ones. The logarithmic gradient provides the most equidistant retention distribution for the DAR species and offers the best overall separation of cysteine linked ADC in HIC...
December 16, 2016: Journal of Chromatography. A
https://www.readbyqxmd.com/read/28011983/refractory-plasmablastic-lymphoma-a-review-of-treatment-options-beyond-standard-therapy
#7
REVIEW
Dominik Pretscher, Alexander Kalisch, Martin Wilhelm, Josef Birkmann
Plasmablastic lymphoma (PBL) is a rare distinct subtype of aggressive diffuse large B-cell lymphoma and a notoriously hard to treat entity with a dismal prognosis in both HIV-negative and HIV-positive patients. Clinicians often face the question of second or third line treatment. As the treatment options with novel agents in lymphomas are rapidly evolving, more and more options beyond standard chemotherapy are available. In connection with a review of treatment options with novel lymphoma agents, we present a case report of a patient with a complete remission after the administration of brentuximab vedotin and lenalidomide...
December 23, 2016: Annals of Hematology
https://www.readbyqxmd.com/read/28010897/brentuximab-vedotin-for-treatment-of-non-hodgkin-lymphomas-a-systematic-review
#8
REVIEW
Garrett K Berger, Ali McBride, Stephanie Lawson, Kelsey Royball, Seongseok Yun, Kevin Gee, Irbaz Bin Riaz, Ahlam A Saleh, Soham Puvvada, Faiz Anwer
BACKGROUND: Brentuximab vedotin (BV) is an antibody-drug conjucate (ADC) comprising a CD30-directed antibody, conjugated to the microtubule-disrupting agent MMAE via a protease cleavable linker. BV is FDA approved for use in relapsed classical Hodgkin lymphoma (HL) and relapsed systemic anaplastic large cell lymphoma (sALCL). There are multiple publications for its utility in other malignancies such as diffuse large B-cell lymphoma (DLBCL), mycosis fungoides (MF), Sézary syndrome (SS), T-cell lymphomas (TCL), primary mediastinal lymphoma (PMBL), and post-transplant lymphoproliferative disorders (PTLD)...
January 2017: Critical Reviews in Oncology/hematology
https://www.readbyqxmd.com/read/27991731/novel-treatment-concepts-in-hodgkin-lymphoma
#9
REVIEW
I Glimelius, A Diepstra
Treatment of classical Hodgkin's lymphoma (HL) has been a success story, with cure of localized disease with radiotherapy in the 1930s, cure of advanced stages with combination chemotherapy with/without radiotherapy in the mid-1960s and continuous improvements since then. Nonetheless, at present approximately 2% of patients with classical HL are primarily refractory to conventional therapy with only 50% becoming long-term survivors. Another 13% of patients relapse, with only 60% being alive 10 years postrecurrence (as exemplified in this review in a Swedish cohort of 18- to 65-year-old patients diagnosed during the period 1992-2009)...
December 19, 2016: Journal of Internal Medicine
https://www.readbyqxmd.com/read/27982313/hodgkin-s-lymphoma-evaluation-of-patients-submitted-to-autologous-transplantation-of-hematopoietic-cells-in-the-hematology-service-of-the-hospital-walter-cant%C3%A3-dio-fortaleza-brazil
#10
Fernando Barroso Duarte, Mabel Gomes de Brito Fernandes, Jacques Kaufmann, Karine Sampaio Nunes Barroso, João Paulo de Vasconcelos Leitão, Beatriz Stela Gomes de Souza Pitombeira Araujo, Clara Maria Bastos Eloy da Costa, Acy Teles Quixadá-Medica, Jacqueline de Souza Holanda, Samuel Vasconcelos Landim, Maria Helena Pitombeira
The Autologous HSCT is an important alternative for refractory or recurrent HL patients in terms of survival and improved quality of life. This study analyzes the results of autologous BMT performed in HL patients in the Transplant Unit of the HUWC/ HEMOCE (Fortaleza - CE, Brazil). Fifty-two transplanted patients were studied from January 2009 to October 2015, among them, 30 men and 22 women, mean age of 28.2 years. All of them received GCS-F during the mobilization, in some cases associated with Vinorelbine or Plerixafor, with CD34 collection averaging 4...
October 2016: Revista da Associação Médica Brasileira
https://www.readbyqxmd.com/read/27973149/cost-effectiveness-of-brentuximab-vedotin-in-relapsed-or-refractory-hodgkin-s-lymphoma-following-autologous-stem-cell-transplant-in-taiwan
#11
D Zou, R Kendall, Q Lin, Y Huang, J Tieng, J Tseng, P Sajosi
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/27972715/cost-effectiveness-of-brentuximab-vedotin-in-relapsed-or-refractory-systemic-anaplastic-large-cell-lymphoma-in-taiwan
#12
D Zou, R Kendall, Q Lin, Y Huang, J Tieng, J Tseng, P Sajosi
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/27972522/cost-effectiveness-analysis-of-brentuximab-vedotin-in-adults-with-relapsed-or-refractory-hodgkin-s-lymphoma
#13
G R Khachatryan, D Fedyaev, M Avxentyeva, V S Dombrovskiy
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/27972517/cost-effectiveness-of-using-brentuximab-vedotin-in-patients-with-recurrent-hodgkin-lymphoma-or-refractory-to-transplant
#14
M E Romero Prada, N C Roa Cardenas, E C Vasquez Melo, G Acero, L M Huerfano, M de Los Rios de Acevedo
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/27972484/real-world-treatment-patterns-and-costs-of-care-among-brentuximab-vendotin-treated-patients-with-hodgkin-lymphoma-in-the-united-states
#15
S M Szabo, I Hirji, K M Johnston, A Juarez-Garcia, M Subar, J M Connors
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/27927047/diagnostic-prognostic-and-therapeutic-role-of-cd30-in-lymphoma
#16
John Matthew R Pierce, Amitkumar Mehta
CD30 is a cell surface receptor expressed in classical Hodgkin lymphoma (HL), anaplastic large cell lymphoma (ALCL), and many other lymphomas to a variable degree. It has been identified as an important therapeutic target in lymphoma. Areas covered: CD30 testing is essential in diagnosis of classical HL and ALCL, and expression can also be seen in other lymphoma subtypes. Development of Brentuximab vedotin (BV), an antibody-drug conjugate directed to CD30, has been an important advance in lymphoma treatment...
January 2017: Expert Review of Hematology
https://www.readbyqxmd.com/read/27913499/novel-agents-and-strategies-in-transplant-eligible-patients-with-relapsed-and-refractory-hodgkin-lymphoma
#17
Craig Moskowitz
The majority of patients with Hodgkin lymphoma are cured with frontline therapy; however, 10% to 15% with early-stage disease and 20% to 30% with advanced stage require second-line therapy that includes a potentially curative transplant, of which an additional 50% to 55% are cured. Those with multiply relapsed disease traditionally would receive novel agents on a clinical trial or combination chemotherapy as a potential bridge to an allogeneic stem cell transplant. This treatment paradigm has changed with the availability of brentuximab vedotin, an antibody drug conjugate used pre- and post-ASCT, as well as for palliation...
December 2, 2016: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/27881581/nivolumab-in-the-treatment-of-hodgkin-lymphoma
#18
Stephen M Ansell
Despite an extensive immune infiltrate that is recruited to the tumor by malignant Reed Sternberg cells in Hodgkin lymphoma, the antitumor immune response is ineffective and unable to eradicate the malignant cells. The ineffective immune response is in part due to PD-1 signaling that renders intratumoral immune cells anergic. Reed Sternberg cells have been shown to upregulate expression of the PD-1 ligands, PD-L1 and PD-L2, due to either genetic alterations at chromosome 9p24.1 or Epstein Barr virus infection, and these ligands suppress the function of PD-1+ intratumoral T-cells...
November 23, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/27868471/brentuximab-vedotin-activity-in-diffuse-large-b-cell-lymphoma-with-cd30-undetectable-by-visual-assessment-of-conventional-immunohistochemistry
#19
Nancy L Bartlett, Mitchell R Smith, Tanya Siddiqi, Ranjana H Advani, Owen A O'Connor, Jeff P Sharman, Tatyana Feldman, Kerry J Savage, Andrei R Shustov, Catherine S Diefenbach, Yasuhiro Oki, Maria Corinna Palanca-Wessels, Mayur Uttarwar, Martha Li, Jing Yang, Eric D Jacobsen
This phase 2 study evaluated brentuximab vedotin monotherapy in CD30-expressing DLBCL; after several patients with little to no CD30 achieved a complete remission (CR), the study evaluated treatment of DLBCL with undetectable CD30 (CD30u) by local visual immunohistochemistry (vIHC). Sixteen of 52 CD30u DLBCL patients (31%) had an objective response (6 CRs [12%]). Median progression-free survival (PFS) was 1.4 months (range, 0.4-15.6) and median overall survival (OS) was 7.5 months (range, 0.7-18.6+). Subsequent CD30 expression quantitated by computer-assisted digital image analysis (cIHC) showed that 11 of 16 CD30u DLBCL responders had ≥1% CD30...
November 20, 2016: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/27837256/pharmacokinetics-immunogenicity-and-safety-of-weekly-dosing-of-brentuximab-vedotin-in-pediatric-patients-with-hodgkin-lymphoma
#20
Jamie E Flerlage, Monika L Metzger, Jianrong Wu, John C Panetta
PURPOSE: Because of the observed success of phase I/II trials, the novel anti-CD30 agent brentuximab vedotin is now being evaluated as a frontline agent in the high-risk pediatric Hodgkin lymphoma trial HLHR13. The objectives of this study were to evaluate the pharmacokinetic variability during weekly dosing of 1.2 mg/kg of brentuximab vedotin, determine factors that may explain this variability, compare our drug exposure with published data, and evaluate toxicity of brentuximab vedotin in the pediatric population...
December 2016: Cancer Chemotherapy and Pharmacology
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