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17 results on '"Uyei, Anne"'

1. Atezolizumab, vemurafenib, and cobimetinib as first-line treatment for unresectable advanced BRAFV600 mutation-positive melanoma (IMspire150): primary analysis of the randomised, double-blind, placebo-controlled, phase 3 trial

Author

Gutzmer, Ralf, Stroyakovskiy, Daniil, Gogas, Helen, Robert, Caroline, Lewis, Karl, Protsenko, Svetlana, Pereira, Rodrigo P, Eigentler, Thomas, Rutkowski, Piotr, Demidov, Lev, Manikhas, Georgy Moiseevich, Yan, Yibing, Huang, Kuan-Chieh, Uyei, Anne, McNally, Virginia, McArthur, Grant A, and Ascierto, Paolo A

Published
2020
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2. Atezolizumab with or without cobimetinib versus regorafenib in previously treated metastatic colorectal cancer (IMblaze370): a multicentre, open-label, phase 3, randomised, controlled trial

Author

Ahn, JB, Asselah, J, Badarinath, S, Baijal, S, Begbie, S, Berry, S, Canon, JL, Carbone, RG, Cervantes, A, Cha, YJ, Chang, K, Chaudhry, A, Chmielowska, E, Cho, SH, Chu, D, Couture, F, Cultrera, J, Cunningham, D, Van Cutsem, E, Cuyle, PJ, Davies, J, Dowden, S, Dvorkin, M, Ganju, V, Garcia, RV, Kerr, R, Kim, TY, King, K, Kortmansky, J, Kozloff, M, Lam, KO, Lee, J, Lee, AS, Lesperance, B, Luppi, G, Ma, B, Maiello, E, Mandanas, R, Marshall, J, Marx, G, Mullamitha, S, Nechaeva, M, Park, JO, Pavlakis, N, Ponce, CG, Potemski, P, Raouf, S, Reeves, J, Segal, N, Siena, S, Smolin, A, Streb, JO, Strickland, A, Szutowicz-Zielinska, E, Tabernero, JM, Tan, B, Valera, JS, Van den Eynde, M, Vergauwe, P, Vickers, M, Womack, M, Wroblewska, M, Young, R, Eng, Cathy, Kim, Tae Won, Bendell, Johanna, Argilés, Guillem, Tebbutt, Niall C, Di Bartolomeo, Maria, Falcone, Alfredo, Fakih, Marwan, Kozloff, Mark, Segal, Neil H, Sobrero, Alberto, Yan, Yibing, Chang, Ilsung, Uyei, Anne, Roberts, Louise, and Ciardiello, Fortunato

Published
2019
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3. Evaluation of atezolizumab (A), cobimetinib (C), and vemurafenib (V) in previously untreated patients with BRAFV600 mutation-positive advanced melanoma: Primary results from the phase 3 IMspire150 trial

Author

McArthur, A. Stroyakovskiy, Daniil Gogas, Helen Robert, Caroline Lewis, Karl Protsenko, Svetlana Pereira, Rodrigo and Eigentler, Thomas Rutkowski, Piotr Demidov, Lev and Manikhas, Georgy Moiseevich Yan, Yibing Huang, K. C. Uyei, Anne McNally, Virgina Gutzmer, Ralf Ascierto, Paolo

Published
2020

6. Multifocal breast cancer in women (less than or equal to) 35 years old

Author

Litton, Jennifer K., Eralp, Yesim, Gonzalez-Angulo, Ana M., Broglio, Kristine, Uyei, Anne, Hortobagyi, Gabriel N., and Arun, Banu

Subjects
Breast cancer -- Demographic aspects, Breast cancer -- Patient outcomes, Breast cancer -- Research, Cancer patients -- Demographic aspects, Cancer patients -- Prognosis, Age factors in disease -- Research, Health
Published
2007

8. Potential Disease-Modifying Activity of Navtemadlin (KRT-232), a First-in-Class MDM2 Inhibitor, Correlates with Clinical Benefits in Relapsed/Refractory Myelofibrosis (MF)

Author

Vachani, Pankit, Lange, Andrzej, Delgado, Regina Garcia, Al-Ali, Haifa Kathrin, Hernández-Rivas, Jesus Maria, Kiladjian, Jean-Jacques, Vannucchi, Alessandro, Perkins, Andrew Charles, Valmeekam, Venu, Krejsa, Cecile Marie, Uyei, Anne, McGreivy, Jesse, Rothbaum, Wayne P., Mascarenhas, John, and Verstovsek, Srdan

Published
2021
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13. A Phase Ib Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Cobimetinib and Duligotuzumab in Patients with Previously Treated Locally Advanced or Metastatic Cancers with Mutant KRAS.

Author

Lieu, Christopher H., Hidalgo, Manuel, Berlin, Jordan D., Ko, Andrew H., Cervantes, Andres, LoRusso, Patricia, Gerber, David E., Eder, J. Paul, Eckhardt, S. Gail, Kapp, Amy V., Tsuhako, Amy, McCall, Bruce, Pirzkall, Andrea, Uyei, Anne, and Tabernero, Josep

Subjects
EVALUATION of clinical trials, CANCER treatment, METASTASIS, COMBINATION drug therapy, DIARRHEA, DRUG side effects, CLINICAL drug trials, DRUG toxicity, GENES, HYPOKALEMIA, MONOCLONAL antibodies, GENETIC mutation, ONCOLOGY, PAIN, PATIENT safety, PROTEINS, RESEARCH, RESEARCH funding, TERMINATION of treatment, PATIENT selection, PROTEIN kinase inhibitors
Abstract

Background. KRAS-mutant tumors possess abnormal mitogen-activated protein kinases (MAPK) pathway signaling, leading to dysregulated cell proliferation. Cobimetinib blocks MAPK signaling. The dual-action antibody duligotuzumab (MEHD7945A) inhibits ligand binding to both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). Blockade of EGFR/HER3 and inhibition of mitogen-activated protein kinase (MEK) in KRAS-mutant tumors may provide additive benefit. Methods. Patients with KRAS-mutant solid tumors were eligible for this phase Ib dose-escalation study with a planned expansion phase. Duligotuzumab was given intravenously (IV) at 1,100 mg every 2 weeks (q2w), while cobimetinib was given orally in a standard 3 + 3 design to identify the recommended phase II dose (RP2D). The primary objective was to evaluate the safety and tolerability of this combination. Results. Twenty-three patients were enrolled. Dose-limiting toxicities (DLTs) included grade 4 hypokalemia and grade 3 mucosal inflammation, asthenia, and dermatitis acneiform. Seventy percent of patients experienced grade 3 or worse adverse events (AEs). Five (22%) and 12 (52%) patients missed at least 1 dose of duligotuzumab and cobimetinib, respectively, and 9 (39%) patients required a cobimetinib dose reduction. Three (13%) patients discontinued due to an AE. Best response was limited to 9 patients with stable disease and 13 patients with progressive disease. Conclusion. Given the limited tolerability and efficacy of this combination, the study did not proceed to expansion stage and closed for enrollment. [ABSTRACT FROM AUTHOR]

Published
2017
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14. Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study.

Author

de la Cruz-Merino, Luis, Di Guardo, Lorenza, Grob, Jean-Jacques, Venosa, Alfredo, Larkin, James, McArthur, Grant A., Ribas, Antoni, Ascierto, Paolo A., Evans, Jeffrey T. R., Gomez-Escobar, Antonio, Barteselli, Giulio, Eng, Susan, Hsu, Jessie J., Uyei, Anne, and Dréno, Brigitte

Subjects
MELANOMA treatment, BRAF genes, METHYL ethyl ketone, ADVERSE health care events, OCULAR manifestations of general diseases, INDOLE compounds, SULFONAMIDES, COMPARATIVE studies, HETEROCYCLIC compounds, RESEARCH methodology, MEDICAL cooperation, MELANOMA, GENETIC mutation, PIPERIDINE, RESEARCH, RESEARCH funding, RETINAL diseases, SKIN tumors, TIME, TRANSFERASES, DISEASE relapse, EVALUATION research, RANDOMIZED controlled trials, THERAPEUTICS
Abstract

Background: Serous chorioretinopathy has been associated with MEK inhibitors, including cobimetinib. We describe the clinical features of serous retinopathy observed with cobimetinib in patients with BRAF V600-mutated melanoma treated in the Phase III coBRIM study.Methods: In the coBRIM study, 493 patients were treated in two randomly assigned treatment groups: cobimetinib and vemurafenib (n = 247) or vemurafenib (n = 246). All patients underwent prospective ophthalmic examinations at screening, at regular intervals during the study, and whenever ocular symptoms developed. Patients with serous retinopathy were identified in the study database using a group of relevant and synonymous adverse event terms.Results: Eighty-six serous retinopathy events were reported in 70 patients (79 events in 63 cobimetinib and vemurafenib-treated patients vs seven events in seven vemurafenib-treated patients). Most patients with serous retinopathy identified by ophthalmic examination had no symptoms or had mild symptoms, among them reduced visual acuity, blurred vision, dyschromatopsia, and photophobia. Serous retinopathy usually occurred early during cobimetinib and vemurafenib treatment; median time to onset was 1.0 month. Most events were managed by observation and continuation of cobimetinib without dose modification and resolved or were resolving by the data cutoff date (19 Sept 2014).Conclusions: Cobimetinib treatment was associated with serous retinopathy in patients with BRAF V600-mutated melanoma. Retinopathy was generally asymptomatic or mild. Periodic ophthalmologic evaluations at regular intervals and at the manifestation of any visual disturbance are recommended to facilitate early detection and resolution of serous retinopathy while patients are taking cobimetinib. Trial Registration Clinicaltrials.gov (NCT01689519). First received: September 18, 2012. [ABSTRACT FROM AUTHOR]

Published
2017
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17. Atezolizumab with or without cobimetinib versus regorafenib in previously treated metastatic colorectal cancer (IMblaze370): a multicentre, open-label, phase 3, randomised, controlled trial

Author

S Mullamitha, P Potemski, JB Ahn, Gavin Marx, David Cunningham, CG Ponce, James A. Jr Reeves, Cathy Eng, J Cultrera, Rachel Kerr, Neil H. Segal, Josep Tabernero, Marwan Fakih, J-L Canon, Salvatore Siena, JO Streb, YJ Cha, A Smolin, Javier Sastre Valera, S Begbie, Anne Uyei, Alberto Sobrero, Andrew Strickland, S Dowden, Ruth Vera Garcia, N Segal, AS Lee, Evaristo Maiello, E Chmielowska, S Badarinath, Niall C. Tebbutt, Tae Won Kim, K King, J Lee, B Lesperance, Ko Lam, M Van den Eynde, Vinod Ganju, B Tan, R. Young, K Chang, Brigette B.Y. Ma, Mark Kozloff, TY Kim, M Dvorkin, Maria Di Bartolomeo, Jo Park, Nick Pavlakis, M Kozloff, Philippe Vergauwe, Yibing Yan, E. Van Cutsem, M Wroblewska, M Womack, Michael M Vickers, Fortunato Ciardiello, Alfredo Falcone, A Chaudhry, Gabriele Luppi, J Kortmansky, Johanna C. Bendell, Ilsung Chang, John Marshall, RG Carbone, PJ Cuyle, R Mandanas, M Nechaeva, Félix Couture, Andrés Cervantes, Guillem Argiles, Scott M. Berry, Sherif Raouf, E Szutowicz-Zielinska, D Chu, SH Cho, John Davies, J. Asselah, S Baijal, Louise Roberts, Eng, Cathy, Kim, Tae Won, Bendell, Johanna, Argilés, Guillem, Tebbutt, Niall C, Di Bartolomeo, Maria, Falcone, Alfredo, Fakih, Marwan, Kozloff, Mark, Segal, Neil H, Sobrero, Alberto, Yan, Yibing, Chang, Ilsung, Uyei, Anne, Roberts, Louise, Ciardiello, Fortunato, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Service d'hépato-gastro-entérologie, and UCL - (SLuc) Service d'oncologie médicale

Subjects
Male, 0301 basic medicine, medicine.medical_specialty, Pyridines, Perforation (oil well), Phases of clinical research, Salvage therapy, Antibodies, Monoclonal, Humanized, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Piperidines, Atezolizumab, Internal medicine, Regorafenib, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Survival rate, Aged, Salvage Therapy, Cobimetinib, business.industry, Phenylurea Compounds, Liver Neoplasms, Middle Aged, Prognosis, Survival Rate, Editorial Commentary, 030104 developmental biology, chemistry, Oncology, 030220 oncology & carcinogenesis, Azetidines, Female, Colorectal Neoplasms, business, Follow-Up Studies
Abstract

Background Microsatellite-stable metastatic colorectal cancer is typically unresponsive to immunotherapy. This phase 3 study was designed to assess atezolizumab plus cobimetinib in metastatic colorectal cancer. Here, we report the comparison of atezolizumab plus cobimetinib or atezolizumab monotherapy versus regorafenib in the third-line setting. Methods IMblaze 370 is a multicentre, open-label, phase 3, randomised, controlled trial, done at 73 academic medical centres and community oncology practices in 11 countries. Patients aged at least 18 years with unresectable locally advanced or metastatic colorectal cancer, baseline Eastern Cooperative Oncology Group performance status of 0–1, and disease progression on or intolerance to at least two previous systemic chemotherapy regimens were enrolled. We used permuted-block randomisation (block size four) to assign patients (2:1:1) via an interactive voice and web response system to atezolizumab (840 mg intravenously every 2 weeks) plus cobimetinib (60 mg orally once daily for days 1–21 of a 28-day cycle), atezolizumab monotherapy (1200 mg intravenously every 3 weeks), or regorafenib (160 mg orally once daily for days 1–21 of a 28-day cycle). Stratification factors were extended RAS status (wild-type vs mutant) and time since diagnosis of first metastasis (

Published
2019

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