Publications by authors named "Anne Paccaly"

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Cemiplimab in Japanese patients with advanced non-small cell lung cancer.
Yuki Sato, Yoko Tani, Hidenobu Ishii, Seigo Katakura, Masahide Oki, Anne Paccaly

Jpn J Clin Oncol· October 2025

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First-in-Human Dose-Escalation Study of Fianlimab, an Antilymphocyte Activation Gene-3 Antibody, with Cemiplimab in Patients with Advanced Malignancies.
Nehal J Lakhani, Kyriakos P Papadopoulos, Melissa Lynne Johnson, Haeseong Park, Ding Wang, Anne Paccaly

Clin Cancer Res· December 2024

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Cemiplimab monotherapy in Japanese patients with recurrent or metastatic cervical cancer.
Kosei Hasegawa, Shunji Takahashi, Kimio Ushijima, Masao Okadome, Kan Yonemori, Anne Paccaly

Cancer Med· September 2024

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Phase I Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced Melanoma.
Omid Hamid, Karl D Lewis, Amy Weise, Meredith McKean, Kyriakos P Papadopoulos, Anne Paccaly

J Clin Oncol· August 2024

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Subcutaneous Administration of Monoclonal Antibodies: Pharmacology, Delivery, Immunogenicity, and Learnings From Applications to Clinical Development.
John D Davis, Marçal Bravo Padros, Daniela J Conrado, Samit Ganguly, Xiaowen Guan, Anne Paccaly

Clin Pharmacol Ther· March 2024

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Safety and Immune Responses Following Anti-PD-1 Monoclonal Antibody Infusions in Healthy Persons With Human Immunodeficiency Virus on Antiretroviral Therapy.
Cynthia L Gay, Ronald J Bosch, Ashley McKhann, Raymond Cha, Gene D Morse, Anne Paccaly

Open Forum Infect Dis· March 2024

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High response rate with extended dosing of cemiplimab in advanced cutaneous squamous cell carcinoma.
Danny Rischin, Brett G M Hughes, Nicole Basset-Séguin, Dirk Schadendorf, Samantha Bowyer, Anne J Paccaly

J Immunother Cancer· March 2024

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Immunogenicity of Cemiplimab: Low Incidence of Antidrug Antibodies and Cut-Point Suitability Across Tumor Types.
Jenny L Valentine, Andrew Dengler, An Zhao, Tiffany Truong, Sean McAfee, Anne Paccaly

J Clin Pharmacol· January 2024

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Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial.
Miranda Gogishvili, Tamar Melkadze, Tamta Makharadze, Davit Giorgadze, Mikhail Dvorkin, Anne Paccaly

Nat Med· November 2022

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Population pharmacokinetics modeling and exposure-response analyses of cemiplimab in patients with recurrent or metastatic cervical cancer.
Jenny-Hoa Nguyen, Daniel Epling, Nancy Dolphin, Anne Paccaly, Daniela Conrado

CPT Pharmacometrics Syst Pharmacol· November 2022

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Bioanalytical Challenges due to Prior Checkpoint Inhibitor Exposure: Interference and Mitigation in Drug Concentration and Immunogenicity Assays.
Andrew F Dengler, Rachel Weiss, Tiffany Truong, Susan C Irvin, Nidhi Gadhia, Anne Paccaly

AAPS J· October 2021

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Population pharmacokinetic characteristics of cemiplimab in patients with advanced malignancies.
Feng Yang, Anne J Paccaly, Ronda K Rippley, John D Davis, A Thomas DiCioccio

J Pharmacokinet Pharmacodyn· August 2021

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Differential Binding of Sarilumab and Tocilizumab to IL-6Rα and Effects of Receptor Occupancy on Clinical Parameters.
Christine Xu, Ashique Rafique, Terra Potocky, Anne Paccaly, Patrick Nolain

J Clin Pharmacol· May 2021

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Fixed Dose of Cemiplimab in Patients with Advanced Malignancies Based on Population Pharmacokinetic Analysis.
Anne J Paccaly, Michael R Migden, Kyriakos P Papadopoulos, Feng Yang, John D Davis

Adv Ther· May 2021

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Pharmacokinetics and Pharmacodynamics of Subcutaneous Sarilumab and Intravenous Tocilizumab Following Single-Dose Administration in Patients With Active Rheumatoid Arthritis on Stable Methotrexate.
Anne J Paccaly, Pavel Kovalenko, Janie Parrino, Anita Boyapati, Christine Xu

J Clin Pharmacol· January 2021

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Dose exploration results from Phase 1 study of cemiplimab, a human monoclonal programmed death (PD)-1 antibody, in Japanese patients with advanced malignancies.
Shigehisa Kitano, Toshio Shimizu, Takafumi Koyama, Takahiro Ebata, Satoru Iwasa, Anne Paccaly

Cancer Chemother Pharmacol· January 2021

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Population Pharmacokinetic-Pharmacodynamic Relationships of Sarilumab Using Disease Activity Score 28-Joint C-Reactive Protein and Absolute Neutrophil Counts in Patients with Rheumatoid Arthritis.
Lei Ma, Christine Xu, Anne Paccaly, Vanaja Kanamaluru

Clin Pharmacokinet· November 2020

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Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis.
Pavel Kovalenko, Anne Paccaly, Anita Boyapati, Christine Xu, Gregory St John

CPT Pharmacometrics Syst Pharmacol· July 2020

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First-In-Human Study of Cemiplimab Alone or In Combination with Radiotherapy and/or Low-dose Cyclophosphamide in Patients with Advanced Malignancies.
Kyriakos P Papadopoulos, Melissa L Johnson, Albert C Lockhart, Kathleen Moore, Gerald S Falchook, Anne Paccaly

Clin Cancer Res· March 2020

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Population Pharmacokinetics of Sarilumab in Patients with Rheumatoid Arthritis.
Christine Xu, Yaming Su, Anne Paccaly, Vanaja Kanamaluru

Clin Pharmacokinet· November 2019

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Immunogenicity of Sarilumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant to Disease-Modifying Antirheumatic Drugs.
Alvin F Wells, Janie Parrino, Erin K Mangan, Anne Paccaly, Yong Lin

Rheumatol Ther· September 2019

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Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis.
Paul Emery, Juan Rondon, Janie Parrino, Yong Lin, Claudia Pena-Rossi, Anne Paccaly

Rheumatology (Oxford)· May 2019

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Disease-Drug Interaction of Sarilumab and Simvastatin in Patients with Rheumatoid Arthritis.
Eun Bong Lee, Nikki Daskalakis, Christine Xu, Anne Paccaly, Barry Miller

Clin Pharmacokinet· June 2017

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Delamanid Coadministered with Antiretroviral Drugs or Antituberculosis Drugs Shows No Clinically Relevant Drug-Drug Interactions in Healthy Subjects.
Suresh Mallikaarjun, Charles Wells, Carolyn Petersen, Anne Paccaly, Susan E Shoaf

Antimicrob Agents Chemother· October 2016

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Utilizing physiologically based pharmacokinetic modeling to inform formulation and clinical development for a compound with pH-dependent solubility.
John Chung, Fernando Alvarez-Nunez, Vincent Chow, Dominick Daurio, John Davis, Anne Paccaly

J Pharm Sci· April 2015

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