Journal Article

AIPAC: a Phase IIb study of eftilagimod alpha (IMP321 or LAG-3Ig) added to weekly paclitaxel in patients with metastatic breast cancer

Dirix, Luc, Triebel, Frédéric

2019

Overview

Eftilagimod alpha (IMP321), a soluble dimeric recombinant form of LAG-3, is a first-in-class antigen presenting cell activator under clinical development. By stimulating dendritic cells through MHC class II molecules, IMP321 was proven to induce sustained immune responses. Combining active immunotherapy with a standard cytotoxic chemotherapy regimen represents a promising novel strategy that might lead to therapeutic improvements in metastatic breast cancer. Here, we describe the rationale and design of AIPAC (NCT02614833), a double-blind, randomized, multicenter Phase IIb study evaluating IMP321 plus paclitaxel as a first-line chemotherapy compared with paclitaxel plus placebo in hormone receptor-positive metastatic breast cancer patients. The primary end point is progression-free survival and key secondary objectives include overall survival, safety, quality of life and objective response rate.

• Publisher: Future Medicine Ltd
• Subject: Adult / Antigens / Antigens, CD - administration & dosage / Antigens, CD - adverse effects / Antineoplastic Agents, Immunological - administration & dosage / Antineoplastic Agents, Immunological - adverse effects / Antineoplastic Combined Chemotherapy Protocols - administration & dosage / Antineoplastic Combined Chemotherapy Protocols - adverse effects / APC activation / Apoptosis / Breast cancer / Breast Neoplasms - drug therapy / Breast Neoplasms - mortality / Breast Neoplasms - pathology / Cancer therapies / chemo-immunotherapy / Chemotherapy / Clinical Trials, Phase II as Topic / Cytotoxicity / Dendritic cells / Dose-Response Relationship, Drug / Double-Blind Method / Drug Administration Schedule / eftilagimod alpha / Endocrine therapy / Female / Humans / immuno-oncology / Immunology / IMP321 / LAG-3Ig / Ligands / Lymphocytes / Metastasis / metastatic breast cancer / Multicenter Studies as Topic / Paclitaxel - administration & dosage / Paclitaxel - adverse effects / Patients / Phase IIb trial / Placebos - administration & dosage / Placebos - adverse effects / Progression-Free Survival / Proteins / Quality of Life / Randomized Controlled Trials as Topic / Recombinant Proteins - administration & dosage / Recombinant Proteins - adverse effects / Signal transduction