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Paclitaxel plus Eftilagimod Alpha, a soluble LAG-3 protein, in metastatic, HR+ breast cancer: results from AIPAC, a randomized, placebo controlled phase IIb trial

Eftilagimod alpha (efti), a soluble lymphocyte activation gene (LAG-3) protein and MHC class II agonist, enhances innate and adaptive immunity. Active Immunotherapy PAClitaxel (AIPAC) evaluated safety and efficacy of efti plus paclitaxel in patients with predominantly endocrine-resistant, hormone re...

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Main Authors: Wildiers, Hans (Author) , Armstrong, Anne (Author) , Cuypere, Eveline (Author) , Dalenc, Florence (Author) , Dirix, Luc (Author) , Chan, Steve (Author) , Marmé, Frederik (Author) , Schröder, Carolina P. (Author) , Huober, Jens (Author) , Duhoux, Francois P. (Author) , Vuylsteke, Peter (Author) , Jager, Agnes (Author) , Brain, Etienne (Author) , Kuemmel, Sherko (Author) , Pápai, Zsuzsanna (Author) , Menke-van der Houven van Oordt, Catharina Willemien (Author) , Perjesi, Luca (Author) , Mueller, Christian (Author) , Brignone, Chrystelle (Author) , Triebel, Frederic (Author)
Format: Article (Journal)
Language:English
Published: 1 February 2024
In: Clinical cancer research
Year: 2024, Volume: 30, Issue: 3, Pages: 532-541
ISSN:1557-3265
DOI:10.1158/1078-0432.CCR-23-1173
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1158/1078-0432.CCR-23-1173
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Author Notes:Hans Wildiers, Anne Armstrong, Eveline Cuypere, Florence Dalenc, Luc Dirix, Steve Chan, Frederik Marme, Carolina P. Schröder, Jens Huober, Francois P. Duhoux, Peter Vuylsteke, Agnes Jager, Etienne Brain, Sherko Kuemmel, Zsuzsanna Pápai, Catharina Willemien Menke-van der Houven van Oordt, Luca Perjesi, Christian Mueller, Chrystelle Brignone, Frederic Triebel
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Summary:Eftilagimod alpha (efti), a soluble lymphocyte activation gene (LAG-3) protein and MHC class II agonist, enhances innate and adaptive immunity. Active Immunotherapy PAClitaxel (AIPAC) evaluated safety and efficacy of efti plus paclitaxel in patients with predominantly endocrine-resistant, hormone receptor-positive, HER2-negative metastatic breast cancer (ET-resistant HR+ HER2− MBC).Women with HR+ HER2- MBC were randomized 1:1 to weekly intravenous paclitaxel (80 mg/m2) and subcutaneous efti (30 mg) or placebo every 2 weeks for six 4-week cycles, then monthly subcutaneous efti (30 mg) or placebo maintenance. Primary endpoint was progression-free survival (PFS) by blinded independent central review. Secondary endpoints included overall survival (OS), safety/tolerability, pharmacokinetics/pharmacodynamics, and quality of life. Exploratory endpoints included cellular biomarkers.114 patients received efti and 112 patients received placebo. Median age was 60 years (91.6% visceral disease, 84.1% ET-resistant, 44.2% with previous CDK4/6 inhibitor treatment). Median PFS at 7.3 months was similar for efti and placebo. Median OS was not significantly improved for efti (20.4 vs. 17.5 months; HR, 0.88; P = 0.197) but became significant for predefined exploratory subgroups. EORTC QLQC30-B23 global health status was sustained for efti but deteriorated for placebo. Efti increased absolute lymphocyte, monocyte and secondary target cell (CD4, CD8) counts, plasma IFNγ and CXCL10 levels.Although the primary endpoint, PFS, was not met, AIPAC confirmed expected pharmacodynamic effects and demonstrated excellent safety profile for efti. OS was not significantly improved globally (2.9-month difference), but was significantly improved in exploratory biomarker subgroups, warranting further studies to clarify efti's role in patients with ET-resistant HER2− MBC.
Item Description:Gesehen am 28.06.2024
Physical Description:Online Resource
ISSN:1557-3265
DOI:10.1158/1078-0432.CCR-23-1173

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