Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2024
Paclitaxel plus Eftilagimod Alpha, a Soluble LAG-3 Protein, in Metastatic, HR+ Breast Cancer: Results from AIPAC, a Randomized, Placebo Controlled Phase IIb Trial.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- Safety of immune checkpoint modulators beyond PD-1/PD-L1 and CTLA-4 in solid tumors: a meta-analysis.JNCI cancer spectrum · 2026Pooled it
- Review
- Efficacy and safety of systemic therapies following progression on CDK4/6 inhibitors in patients with HR+/HER2- metastatic breast cancer: a systematic review and network meta-analysis.EClinicalMedicine · 2025Article
- Unlocking the Potential of Immune Checkpoint Inhibitors in HR+/HER2- Breast Cancer: A Systematic Review.Cancers · 2025Review
- Immunotherapy and its racial specificity for breast cancer treatment in Asia: a narrative review.The Lancet regional health. Western Pacific · 2025Review
- Breast cancer scoring based on a multiplexed profiling of soluble and cell-associated (immune) markers facilitates the prediction of pembrolizumab therapy.Cancer cell international · 2025Article
- Exploration of the role of drug resistance-associated anoikis-related genes in HER2-Negative breast cancer through bioinformatics analysis.Biochemistry and biophysics reports · 2025Article
- LAG Time in the Era of Immunotherapy-New Molecular Insights Into the Immunosuppression Mechanism of Lymphocyte Activation Gene-3.Immunological reviews · 2025Review
- Prognostic significance of the inhibitory-to-stimulatory immune checkpoint ratio in patients with breast cancer.Frontiers in oncology · 2025Article
- The Trojan Horse Within: Mechanisms of Immune Evasion in Breast Cancer.Cancer heterogeneity and plasticity · 2025Article
- Current and future immunotherapy for breast cancer.Journal of hematology & oncology · 2024Review
- Eftilagimod Alpha (a Soluble LAG-3 Protein) Combined With Pembrolizumab in Second-Line Metastatic NSCLC Refractory to Anti-Programmed Cell Death Protein 1/Programmed Death-Ligand 1-Based Therapy: Final Results from a Phase 2 Study.JTO clinical and research reports · 2024Article
- Review
- Soluble immune checkpoint molecules in cancer risk, outcomes prediction, and therapeutic applications.Biomarker research · 2024Review
Corrections and comments
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Authors and funding
20 authors at 18 institutions in 8 countries.
Funding
Abstract
purposeEftilagimod 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). PATIENTS AND
methodsWomen 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.
results114 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.
conclusionsAlthough 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.
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