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Poster Display session

11P - Results of a phase II study investigating eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in 2nd line PD-1/PD-L1 refractory metastatic non-small cell lung carcinoma pts


03 Apr 2022


Poster Display session


Tumour Site

Non-Small Cell Lung Cancer


Matthew Krebs


Annals of Oncology (2022) 33 (suppl_2): S27-S70. 10.1016/annonc/annonc856


M.G. Krebs1, M. Majem Tarruella2, M. Forster3, J.A. Peguero4, T. Clay5, E. Felip6, W. Iams7, P. Roxburgh8, B. Doger de Spéville9, P. Bajaj10, C. Mueller11, F. Triebel12

Author affiliations

  • 1 Division of Cancer Sciences, The University of Manchester and The Christie NHS Foundation Trust, Manchester/GB
  • 2 Hospital de la Santa Creu i Sant Pau, 8041 - Barcelona/ES
  • 3 UCL Cancer Institute / University College London Hospitals NHS Foundation, NW1 2PG - London/GB
  • 4 Oncology Consultants, Houston/US
  • 5 St John of God Subiaco Hospital, Perth/AU
  • 6 Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona/ES
  • 7 Vanderbilt Ingram Cancer Center Division of Hematology/Oncology, 37232 - Nashville/US
  • 8 Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow and Beatson West of Scotland Cancer Centre, Glasgow/GB
  • 9 Fundación Jiménez Diaz, Madrid/ES
  • 10 Tasman Oncology, Queensland/AU
  • 11 Immutep GmbH, Leipzig/DE
  • 12 Immutep S.A.S., Orsay/FR

Abstract 11P


Eftilagimod alpha (efti) is a soluble LAG-3 protein binding to a subset of MHC class II molecules to mediate antigen presenting cell (APC) and CD8 T-cell activation. Stimulating APCs and subsequent T cell recruitment with efti may revert PD-1 resistance. We hereby report results from part B, 2nd line PD-1/PD-L1 refractory non-small cell lung carcinoma (NSCLC), of the TACTI-002 trial.


Patients (pts) with previously treated metastatic NSCLC, refractory to PD-1/PD-L1 and unselected for PD-L1 expression were enrolled. A Simon's 2-stage design was used, with objective response rate (ORR) by iRECIST as the primary endpoint (EP). Secondary EPs include ORR by RECIST 1.1, tolerability, disease control rate (DCR), progression free survival and overall survival. Pts received 30 mg efti (SC) q2w for 8 cycles (1 cycle= 3 wks) and then q3w for up to one year together with pembrolizumab (200 mg IV q3w for up to 2 years). Imaging was performed every 8 weeks and evaluated locally. The study was approved by relevant authorities and ethics committees.


36 pts were enrolled in this cohort. Median age was 66 years (50-84) and 61 % were male. The ECOG PS was 0 and 1 in 33 % and 67 % of pts, respectively. Pts had squamous (19 %) and non-squamous (78 %) NSCLC. Pts were pretreated with a PD-1/ PD-L1 antagonist alone (33 %) or in combination with platinum-based chemo (67 %). All PD-L1 subgroups were included with 36 % being PD-L1 negative. Pts received a median 4.0 (range 1–18) pembrolizumab and 5.0 (range 1-22) efti administrations. 2 pts discontinued treatment due to adverse reactions (ARs) (5.6 %). The most common (>15 %) AEs were decreased appetite (33 %), dyspnea (31 %), cough (25 %), asthenia (22 %), fatigue (17 %) and weight decreased (17 %). At data cut-off (Nov2021) 36 pts were evaluated for response with a min. follow-up of ≥4 months. ORR (iRECIST) and DCR was 6 % (2/36) and 36 % (13/36), respectively. Both responses were reported in pts pre-treated with chemo + PD-1 and under therapy since 7+ and 12+ months at data cut-off.


Efti in combination with pembrolizumab is safe and shows encouraging signs of antitumor activity in PD-1 refractory 2nd line NSCLC pts.

Clinical trial identification

EudraCT 2018-001994-25; NCT03625323.

Legal entity responsible for the study

Immutep S.A.


Immutep S.A.


M.G. Krebs: Other, Personal, Speaker’s Bureau: Roche, Janssen, AstraZeneca; Other, Institutional, Funding: Roche (Inst); Other, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca; BerGenBio; Immutep; Other, Personal, Other, Consulting or Advisory Role: Janssen; Roche, Bayer, Seattle Genetics; Other, Personal, Other, Honoraria: Roche, Janssen. M. Majem Tarruella: Other, Personal, Other, Consulting or Advisory Role: AstraZeneca; Boehringer Ingelheim; Bristol Myers Squibb;Helsinn Therapeutics; Lilly; MSD; Novartis; Pfizer; Roche; Takeda; Tesaro; Other, Institutional, Funding: Bristol Myers Squibb(Inst); Other, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca; Roche. M. Forster: Other, Personal, Other, Consulting or Advisory Role : Achilles Therapeutics; AstraZeneca; Bayer; Bristol Myers Squibb; Celgene; Guardant Health; Lilly; MSD; Nanobiotix; Novartis; Oxford VacMedix; Pfizer; PharmaMar; Roche; Takeda; Other, Institutional, Funding: AstraZeneca (Inst); Boehringer Ingelheim (Inst); Merck Serono (Inst); MSD Oncology (Inst); Other, Personal, Other, Travel, Accommodations, Expenses: AstraZeneca; Bristol Myers Squibb; Celgene; Guardant Health; MSD Oncology; Roche. J.A. Peguero: Other, Personal, Other, Employment: Oncology Consultants, P.A.; Other, Personal, Leadership Role: Director, Research Department. T. Clay: Other, Personal, Other, Honoraria : AstraZeneca; Novartis; Roche; Other, Personal, Speaker’s Bureau: AstraZeneca; Novartis; Novartis; Other, Institutional, Funding: Bayer (Inst); Bayer (Inst); BeyondSpring Pharmaceuticals (Inst); Clovis Oncology (Inst); Exelixis (Inst); Immutep (Inst); MSD (Inst); Other, Personal, Other, Travel, Accommodations, Expenses : Astellas Pharma; Astra Zeneca; Bristol Myers Squibb; Foundation Medicine; Roche/Genentech. E. Felip: Other, Personal, Other, Advisory Board and Invited Speaker : Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Janssen, MSD, Merck Serono, Pfizer; Other, Personal, Advisory Board: Bayer, BeiGene, Boehringer Ingelheim, GlaxsoSmithKline, Medical Trends, Peptomyc, Puma Biotechnology, Regeneron, Sanofi, Takeda; Other, Personal, Invited Speaker: PeerVoice, Springer, Touch Medical; Other, Institutional, Funding: Grant for Oncology Innovation, Merck Healthcare KGaA, Fundación Merck Salud; Other, Personal, Other, Independent Member of the Board: GRÍFOLS. W. Iams: Other, Personal, Advisory Board: Genentech, Jazz Pharma, G1 Therapeutics, Mirati, Bristol Myers Squibb, Takeda, Janessen; Other, Personal, Other, Consultant: OncLive, Clinical Care Options, Chardan, Outcomes Insights, Cello Health, Curio Science. P. Roxburgh: Other, Institutional, Funding: AstraZeneca, Tesaro/GlaxoSmithKline, Atrios; Other, Personal, Other, Honoraria: AstraZeneca, Tesaro/GlaxoSmithKline; Other, Institutional, Funding, Funding to institution for role as site PI: Sierra Oncology, PsiOxus, AstraZeneca, Starpharma, Forma Therapeutics, Iovance, Immutep, Bayer, Athenex, Replimune, Clovis, Nucana. C. Mueller: Financial Interests, Personal, Other, Employment: Immutep. F. Triebel: Financial Interests, Personal, Other, Employment: Immutep SAS; Financial Interests, Personal, Stocks/Shares: Immutep Ltd; Non-Financial Interests, Personal, Other, Patents, Royalties, Other Intellectual Property: Being an inventor on patents on LAG-3 owned by Immutep SAS. All other authors have declared no conflicts of interest.

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