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    Final results from AIPAC: a phase IIB comparing eftilagimod alpha (a soluble lag-3 protein) vs. placebo in combination with weekly paclitaxel in HR+HER2-MBC

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    Authors
    Wildiers, H.
    Dirix, L.
    Armstrong, Anne C
    De Cuypere, E.
    Dalenc, F.
    Chan, S.
    Marme, F.
    Schroder, C. P.
    Huober, J.
    Vuylsteke, P.
    Jacquin, J. P.
    Brain, E.
    Kummel, S.
    Papai, Z.
    Mueller, C.
    Brignone, C.
    Triebel, F.
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    Affiliation
    University Hospitals Leuven; Department of General Medical Oncology and Multidisciplinary Breast Centre, Leuven, Belgium
    Issue Date
    2021
    
    Metadata
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    Abstract
    Background Eftilagimod alpha (efti; IMP321) is a soluble LAG-3 protein (LAG-3Ig) that binds to a subset of MHC class II molecules and mediates activation of antigen-presenting cells followed by CD8 T-cells. Weekly paclitaxel is a standard of care chemo-regimen after failure of endocrine-based therapy for metastatic breast carcinoma (MBC). AIPAC (Active Immunotherapy PAClitaxel) investigated the addition of efti to weekly paclitaxel in these patients (pts). Methods This placebo-controlled, double-blinded, 1:1 randomized phase IIb trial enrolled pts with measurable disease, HR+ HER2- MBC after endocrine-based therapy. Pts received paclitaxel (80 mg/m² IV on D1, D8, D15) + efti (30 mg) or placebo on D2, D16 (every 2 weeks) for up to 24 weeks following efti/placebo for up to 52 weeks. The primary endpoint (EP) was progression-free survival (RECIST1.1) by BICR. Secondary EPs included overall survival (OS), PFS (local read), overall response rate (ORR), biomarker, quality of life. Exploratory EPs included univariate/multivariate analyses. Results 227 pts were randomized (Jan2017-Jul2019). All except 1 received ≥1 treatment and were included in the full analysis set [efti (n=114); placebo (n=112)]. Data cut-off was 14May2021 (min. follow-up= 22 months). Median age was 60 yrs with ECOG 0 in 61.5%. 91.6% had visceral disease. Pts were mostly endocrine resistant (84%) and partially pre-treated with CDK4/6 inhibitors (44.2%). Post-study treatment was similar. Median OS was 20.4 (95% CI: 14.3-25.1) months in the efti group vs. 17.5 (95% CI: 12.9-21.9) in the placebo group. HR was 0.88 (95%CI: 0.64-1.19; p=0.197). In predefined univariate analyses, younger pts, low baseline monocytes and luminal B showed significant/clinically meaningful improvement in OS (table 1). Efti increased PBMC/T cell (CD4/CD8) count vs. placebo, correlating with improved OS (Spearman Rho=0.6, p=0.02 for CD8 T cells). In a whole population multivariate cox regression model, increasing BMI and prior treatment with CDK4/6 were independent significant poor prognostic markers for PFS and OS. TEAEs leading to discontinuation were similar at 5.3%(efti) & 6.3%(placebo). PFS (Primary EP) and safety were reported at SABCS 2020 (Abstract#132).
    Citation
    Wildiers H, Dirix L, Armstrong A, Cuypere ED, Dalenc F, Chan S, et al. 948 Final results from AIPAC: A phase IIb comparing eftilagimod alpha (a soluble LAG-3 protein) vs. placebo in combination with weekly paclitaxel in HR+ HER2- MBC. Vol. 9, Journal for ImmunoTherapy of Cancer. BMJ; 2021. p. A997–A997.
    Journal
    Journal for Immunotherapy of Cancer
    URI
    http://hdl.handle.net/10541/625238
    DOI
    10.1136/jitc-2021-SITC2021.948
    Additional Links
    https://dx.doi.org/10.1136/jitc-2021-SITC2021.948
    Type
    Meetings and Proceedings
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1136/jitc-2021-SITC2021.948
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