المؤلفون: Dirk Schadendorf, Thomas K Eigentler, Israel Lowy, Apostolos Papachristos, Samantha Bowyer, Friedegund Meier, Brigitte Dreno, Danny Rischin, Michael R Migden, Annette M Lim, Chrysalyne D Schmults, Brett G M Hughes, Axel Hauschild, Brian Stein, Emmanuel Okoye, Jocelyn Booth, Matthew G Fury, Alexander Guminski, Sophie Dalac, Frank Seebach, Marie Beylot-Barry, Suk-Young Yoo, Nicole Basset-Séguin, Sabiha Trabelsi Messai, Victoria Casado Echarren, Anne J Paccaly, Jenny-Hoa Nguyen

المصدر: Journal for ImmunoTherapy of Cancer, Vol 12, Iss 3 (2024)

مصطلحات موضوعية: Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282

الوصف: Background Cemiplimab (Libtayo®), a human monoclonal immunoglobulin G4 antibody to the programmed cell death-1 receptor, is approved for the treatment of patients with advanced cutaneous squamous cell carcinoma (CSCC), who are not candidates for curative surgery or curative radiation, using an every-3-weeks (Q3W) dosing interval. Pharmacokinetic modeling indicated that Ctrough of extended intravenous dosing of 600 mg every 4 weeks (Q4W) would be comparable to the approved intravenous dosage of 350 mg Q3W. We examined the efficacy, pharmacokinetics, and safety of cemiplimab dosed Q4W.Methods In this open-label, phase II trial (ClinicalTrials.gov identifier NCT02760498), the cohort of patients ≥18 years old with advanced CSCC received cemiplimab 600 mg intravenously Q4W for up to 48 weeks. Tumor measurements were recorded every 8 weeks. The primary endpoint was objective response rate by independent central review.Results Sixty-three patients with advanced CSCC were treated with cemiplimab. The median duration of follow-up was 22.4 months (range: 1.0–39.8). An objective response was observed in 39 patients (62%; 95% CI: 48.8% to 73.9%), with 22% of patients (n=14) achieving complete response and 40% (n=25) achieving partial response. The most common treatment-emergent adverse events were diarrhea, pruritus, and fatigue.Conclusions Extended dosing of cemiplimab 600 mg intravenously Q4W exhibited substantial antitumor activity, rapid and durable responses, and an acceptable safety profile in patients with advanced CSCC. These results confirm that cemiplimab is a highly active therapy for advanced CSCC. Additional data would help ascertain the benefit−risk profile for the 600 mg intravenous dosing regimen compared with the approved regimen.

وصف الملف: electronic resource

العلاقة: https://jitc.bmj.com/content/12/3/e008325.fullTest; https://doaj.org/toc/2051-1426Test

الوصول الحر: https://doaj.org/article/85c0508e98f2481db714933c819add16Test

المؤلفون: Dirk Schadendorf, Chieh-I Chen, Zhen Chen, Israel Lowy, Elizabeth Stankevich, Danny Rischin, Michael R Migden, Annette M Lim, Chrysalyne D Schmults, Brett G M Hughes, Anne Lynn S Chang, Emmanuel Okoye, Jocelyn Booth, Siyu Li, Matthew G Fury, Alexander Guminski, Medha Sasane, Alesha A Thai, Suk-Young Yoo, Vera Mastey

المصدر: Journal for ImmunoTherapy of Cancer, Vol 9, Iss 8 (2021)

مصطلحات موضوعية: Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282

الوصف: Background To provide pooled longer term data from three groups of a phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC), and to determine duration of response (DOR) and impact on quality of life (QoL).Methods Patients received cemiplimab 3 mg/kg every 2 weeks (group 1, metastatic CSCC [mCSCC], n=59; group 2, locally advanced CSCC, n=78) or cemiplimab 350 mg every 3 weeks (group 3, mCSCC, n=56). Primary endpoint was objective response rate (ORR) per independent central review (ICR). QoL was repeatedly measured at day 1 of each treatment cycle (groups 1 and 2: 8 weeks; group 3: 9 weeks).Results Median duration of follow-up was 15.7 months. Overall, ORR per ICR was 46.1% (95% CI: 38.9% to 53.4%). Complete response (CR) rates were 20.3%, 12.8%, and 16.1% for groups 1, 2, and 3, respectively. Median time to CR was 11.2 months. Among patients with partial response or CR, the estimated proportion of patients with ongoing response at 12 months from the first objective response was 87.8% (95% CI: 78.5% to 93.3%), with median DOR not reached. Kaplan-Meier estimated probability of overall survival (OS) was 73.3% (95% CI: 66.1% to 79.2%) at 24 months, with median OS not reached. Global Health Status (GHS)/QoL improvements were observed as early as cycle 2 and were significantly improved and durable until last assessment. Kaplan-Meier estimate of median time to first clinically meaningful improvement for pain was 2.1 (95% CI: 2.0 to 3.7) months and was significantly improved in responders versus non-responders (p

وصف الملف: electronic resource

العلاقة: https://jitc.bmj.com/content/9/8/e002757.fullTest; https://doaj.org/toc/2051-1426Test

الوصول الحر: https://doaj.org/article/909409bad2c44f6ca8b681b154002319Test

المؤلفون: Marcus Butler, Rogerio Neves, Lisa Licitra, Israel Lowy, Zeynep Eroglu, Karl Lewis, Leonel Hernandez-Aya, Axel Hauschild, Emmanuel Okoye, Siyu Li, Jean-Francois Baurain, Oliver Bechter, Ketty Peris, Aleksandar Sekulic, Alexander Stratigos, Lara Dunn, Anne Lynn Chang, Michael Migden, Kosalai Mohan, Ebony Coates, Emily Ruiz, Frank Seebach, David Weinreich, George Yancopoulos, Timothy Bowler, Matthew Fury

المصدر: Journal for ImmunoTherapy of Cancer, Vol 8, Iss Suppl 3 (2020)

مصطلحات موضوعية: Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282

وصف الملف: electronic resource

العلاقة: https://doaj.org/toc/2051-1426Test

الوصول الحر: https://doaj.org/article/657146515d294ae39d54d915d166a66eTest

المؤلفون: Thomas Eigentler, Danny Rischin, Michael R Migden, Annette M Lim, Chrysalyne D Schmults, Nikhil I Khushalani, Lara A Dunn, Leonel Hernandez-Aya, Anne Lynn S Chang, Badri Modi, Claas Ulrich, Brian Stein, Jessica L Geiger, Emmanuel Okoye, Melissa Mathias, Jocelyn Booth, Siyu Li, Matthew G Fury

المصدر: Journal for ImmunoTherapy of Cancer, Vol 8, Iss 1 (2020)

مصطلحات موضوعية: Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282

الوصف: Background Cemiplimab, a high-affinity, potent human immunoglobulin G4 monoclonal antibody to programmed cell death-1 demonstrated antitumor activity in a Phase 1 advanced cutaneous squamous cell carcinoma (CSCC) expansion cohort (NCT02383212) and the pivotal Phase 2 study (NCT02760498). Here we report the primary analysis of fixed dose cemiplimab 350 mg intravenously every 3 weeks (Q3W) (Group 3) and provide a longer-term update after the primary analysis of weight-based cemiplimab 3 mg/kg intravenously every 2 weeks (Q2W) (Group 1) among metastatic CSCC (mCSCC) patients in the pivotal study (NCT02760498).Methods The primary objective for each group was objective response rate (ORR) per independent central review (ICR). Secondary endpoints included ORR by investigator review (INV), duration of response (DOR) per ICR and INV, and safety and tolerability.Results For Group 3 (n=56) and Group 1 (n=59), median follow-up was 8.1 (range, 0.6 to 14.1) and 16.5 (range, 1.1 to 26.6) months, respectively. ORR per ICR was 41.1% (95% CI, 28.1% to 55.0%) in Group 3, 49.2% (95% CI, 35.9% to 62.5%) in Group 1, and 45.2% (95% CI, 35.9% to 54.8%) in both groups combined. Per ICR, Kaplan–Meier estimate for DOR at 8 months was 95.0% (95% CI, 69.5% to 99. 3%) in responding patients in Group 3, and at 12 months was 88.9% (95% CI, 69.3% to 96.3%) in responding patients in Group 1. Per INV, ORR was 51.8% (95% CI, 38.0% to 65.3%) in Group 3, 49.2% (95% CI, 35.9% to 62.5%) in Group 1, and 50.4% (95% CI, 41.0% to 59.9%) in both groups combined. Overall, the most common adverse events regardless of attribution were fatigue (27.0%) and diarrhea (23.5%).Conclusion In patients with mCSCC, cemiplimab 350 mg intravenously Q3W produced substantial antitumor activity with durable response and an acceptable safety profile. Follow-up data of cemiplimab 3 mg/kg intravenously Q2W demonstrate ongoing durability of responses.Trial registration number Clinicaltrials.gov, NCT02760498. Registered May 3, 2016, https://clinicaltrials.gov/ct2/show/NCT02760498Test

وصف الملف: electronic resource

العلاقة: https://jitc.bmj.com/content/8/1/e000775.fullTest; https://doaj.org/toc/2051-1426Test

الوصول الحر: https://doaj.org/article/a6c7cd3cc4a44c238d9eeebc62a5df0fTest

المؤلفون: Axel Hauschild, Frank Seebach, Jean-François Baurain, Aleksandar Sekulic, Marcus O. Butler, Alexander J. Stratigos, Suk-Young Yoo, Matthew G. Fury, Leonel Hernandez-Aya, Israel Lowy, Kosalai Kal Mohan, Ebony Coates, Siyu Li, Katty Peris, Lisa Licitra, Rogerio I. Neves, Karl D. Lewis, Zeynep Eroglu, Oliver Bechter, Lara Dunn, Emmanuel Okoye, Timothy Bowler, Emily S. Ruiz, Michael R. Migden, Anne Lynn S. Chang

مصطلحات موضوعية: Microbiology

الوصف: not available.

العلاقة: url:https://www.openaccessrepository.it/communities/itmirrorTest; https://www.openaccessrepository.it/record/118807Test

الإتاحة: https://doi.org/10.25251/skin.5.supp.3Test
https://www.openaccessrepository.it/record/118807Test

المؤلفون: Israel Lowy, Emmanuel Okoye, Frank Seebach, Reinhard Dummer, Aleksandar Sekulic, Zeynep Eroglu, Jens Ulrich, Gavin Thurston, Ioannis D. Bassukas, Timothy Bowler, Michael R. Migden, Anne Lynn S. Chang, Vincent De Giorgi, Kosalai Kal Mohan, Susana Puig, Ebony Coates, Lisa Licitra, Nicole Basset-Segiun, Siyu Li, Oliver Bechter, Carmen Loquai, Matthew G. Fury, Axel Hauschild, Martin Kaatz, Ketty Peris, Claas Ulrich, Stephanie Dalle, Nathalie Flaschi, Caroline Robert, Karl D. Lewis, Ralf Gutzmer, Alexander J. Stratigos, Almudena Fernandez Orland, Vladimir Jankovic

مصطلحات موضوعية: FORTHEM Alliance, Microbiology

الوصف: not available.

العلاقة: url:https://www.openaccessrepository.it/communities/itmirrorTest; https://www.openaccessrepository.it/record/118809Test

الإتاحة: https://doi.org/10.25251/skin.5.supp.4Test
https://www.openaccessrepository.it/record/118809Test

المؤلفون: Karl D Lewis, Ketty Peris, Aleksandar Sekulic, Alexander J Stratigos, Lara Dunn, Zeynep Eroglu, Anne Lynn S Chang, Michael R Migden, Suk-Young Yoo, Kosalai Mohan, Ebony Coates, Emmanuel Okoye, Jean-François Baurain, Oliver Bechter, Axel Hauscild, Marcus O Butler, Leonel Hernandez-Aya, Lisa Licitra, Rogerio I Neves, Emily S Ruiz, Frank Seebach, Israel Lowy, Priscila Goncalves, Matthew G Fury

المصدر: SKIN The Journal of Cutaneous Medicine. 7:s177

مصطلحات موضوعية: Dermatology

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::575b77c3ce4b79460045b75869d17cd0Test
https://doi.org/10.25251/skin.7.supp.177Test

المؤلفون: Alexander J Stratigos, Aleksandar Sekulic, Ketty Peris, Oliver Bechter, Sorilla Prey, Martin Kaatz, Karl D Lewis, Nicole Basset-Seguin, Anne Lynn S Chang, Stéphane Dalle, Almudena Fernandez Orland, Lisa Licitra, Caroline Robert, Claas Ulrich, Axel Hauschild, Michael R Migden, Reinhard Dummer, Suk-Young Yoo, Ebony Coates, Emmanuel Okoye, Ioannis Bassukas, Carmen Loquai, Vincenzo De Giorgi, Zeynep Eroglu, Ralf Gutzmer, Jens Ulrich, Susana Puig, Frank Seebach, Israel Lowy, Matthew G Fury

المصدر: SKIN The Journal of Cutaneous Medicine. 7:s178

مصطلحات موضوعية: Dermatology

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::96e03c6513a909899152d80a325dcc73Test
https://doi.org/10.25251/skin.7.supp.178Test

المؤلفون: Okey Marcellus Ikeanyibe, Ogbonnaya Eze Ori, Arinze Emmanuel Okoye, Marcellus Okey, PhD, is a Senior Lecturer Ikeanyibe

المساهمون: The Pennsylvania State University CiteSeerX Archives

المصدر: https://www.cogentoa.com/article/10.1080/23311886.2017.1316916.pdfTest.

الوصف: This paper reviews the developmental oscillations in the field of public administration or what scholars usually describe as paradigm shifts up to the one of the current emphasis described as the governance model, which subscribes to the use of stakeholders, networks, collaboration, and partnerships in policy and government processes. This paper examines how this core principle or tenet of the model relates to the broad issues of governance in Nigeria, a multi stakeholder, ethnically constituted polity. It is argued that the idea of quota, federal character and other means of power sharing for inclusive government that have been tied to administrative law and practice from the Nigerianization policy of late 1950s till present have not properly doused the aspirations of some major stake holders (ethnic groups) of the country. Hence, the recurrent calls for political and economic restructuring of the country. As a result of this, far-reaching governance and public service reform measures in the country have remained ineffective. The paper suggests that the sticky point in a country like Nigeria about governance challenges is how to build a consensus around some enduring socio-political and economic organisation and interrelationship of various groups or stakeholders.

وصف الملف: application/pdf

العلاقة: http://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.1083.5163Test

الإتاحة: https://doi.org/10.1080/23311886.2017.1316916.pdfTest

المؤلفون: Mark D. Stewart, Bruce McCall, Marcelo Pasquini, Allen S. Yang, Carolyn D. Britten, Meredith Chuk, R Angelo De Claro, Bindu George, Nicole Gormley, Mary M. Horowitz, Eric Kowack, Candice McCoy, Phuong Khanh Morrow, Emmanuel Okoye, Rosanna Ricafort, John Rossi, Elad Sharon, Marc Theoret, Ferdinando Vegni, Tai Yu, Jeff Allen

المصدر: Cytotherapy. 24(7)

مصطلحات موضوعية: Cancer Research, Transplantation, Clinical Trials as Topic, Immunology, Cell Biology, Immunotherapy, Adoptive, Oncology, Neoplasms, Antibodies, Bispecific, Immunology and Allergy, Humans, Immunotherapy, Cytokine Release Syndrome, Genetics (clinical)

الوصف: As cancer immunotherapies continue to expand across all areas of oncology, it is imperative to establish a standardized approach for defining and capturing clinically important toxicities, such as cytokine release syndrome (CRS). In this paper, we provide considerations for categorizing the variety of adverse events that may accompany CRS and for recognizing that presentations of CRS may differ among various immunotherapies (e.g., monoclonal antibodies, CAR T cell therapies and T cell engagers, which can include bispecific antibodies and other constructs). The goals of this paper are to ensure accurate and consistent identification of CRS in patients receiving immunotherapies in clinical studies to aid in reporting; enable more precise evaluation of the therapeutic risk-benefit profile and cross-study analyses; support evidence-based monitoring and management of important toxicities related to cancer immunotherapies; and improve patient care and outcomes. These efforts will become more important as the number and variety of molecular targets for immunotherapies broaden and as therapies with novel mechanisms continue to be developed.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::57d7f3db31555dcdaaef6afcc55cb85dTest
https://pubmed.ncbi.nlm.nih.gov/35219582Test