A randomized, double-blind, single-dose study (LAVENDER) to assess the safety, tolerability, pharmacokinetics, and immunogenicity of a combined infusion of ABP 980 and pertuzumab in healthy subjects

• Published in: Cancer chemotherapy and pharmacology Vol. 88; no. 5; pp. 879 - 886
• Main Authors: Hanes, Vladimir, Chow, Vincent, Stewart, Tina, Puri, Adeep
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.11.2021; Springer Nature B.V
• Subjects: Adult; Adverse events; Antibodies - blood; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - blood; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - immunology; Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological products; Biosimilar Pharmaceuticals - administration & dosage; Biosimilar Pharmaceuticals - blood; Breast cancer; Cancer Research; Cancer therapies; Chemotherapy; Clinical trials; Dosage; Double-Blind Method; Double-blind studies; Drug dosages; Electrocardiography; Healthy Volunteers; Humans; Immunogenicity; Immunotherapy; Intravenous administration; Male; Medical prognosis; Medicine; Medicine & Public Health; Metastasis; Monoclonal antibodies; Oncology; Original; Original Article; Pharmacokinetics; Pharmacology; Pharmacology/Toxicology; Safety; Targeted cancer therapy; Trastuzumab; Trastuzumab - administration & dosage; Trastuzumab - blood; Trastuzumab - immunology; Biosimilars; Co-infusion; Pertuzumab; ABP 980; Safety; Pharmacokinetics; Trastuzumab

Purpose ABP 980 (KANJINTI ™ ) is a biosimilar to reference product HERCEPTIN ® (trastuzumab RP). The goal of this study was to characterize the safety, tolerability, and immunogenicity of ABP 980 plus pertuzumab (PERJETA ® ) when co-administered in a single infusion bag in healthy subjects. Methods...