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Mini Oral session 2

3MO - Comprehensive biomarkers (BMs) analysis to predict efficacy of PD1/L1 immune checkpoint inhibitors (ICIs) in combination with chemotherapy: a subgroup analysis of the Precision Immuno-Oncology for advanced Non-Small CEll Lung CancER (PIONeeR) trial


08 Dec 2022


Mini Oral session 2


Tumour Immunology;  Immunotherapy

Tumour Site

Non-Small Cell Lung Cancer


Fabrice Barlesi


Annals of Oncology (2022) 16 (suppl_1): 100100-100100. 10.1016/iotech/iotech100100


F. Barlesi1, F. Monville2, C. Audigier Valette3, S. Martinez4, N. Cloarec5, S. Van Hulst6, L. Odier7, F. Vely8, L. Juquel8, L. Arnaud9, S. Bokobza10, M. Hamimed11, M. Karlsen12, P. Dufosse12, A. Pouchin8, L. Ghezali2, M. Le Ray8, J. Fieschi-Meric2, S. Benzekry12

Author affiliations

  • 1 Gustave Roussy - Aix Marseille Université, Villejuif/FR
  • 2 Veracyte, Inc. - EU Headquarters, Marseille, Cedex/FR
  • 3 Hopital Sainte Musse, 83100 - Toulon/FR
  • 4 CH du Pays d'Aix, Aix-en-Provence/FR
  • 5 CH Henri Duffaut, Avignon/FR
  • 6 CHU Nimes - Hopital Universitaire Carémeau, Nimes, Cedex/FR
  • 7 Hopital Nord Ouest, Gleize/FR
  • 8 Aix Marseille Université, APHM, Marseille/FR
  • 9 Hopital de la Conception Assistance Publique des Hopitaux de Marseille, Marseille/FR
  • 10 Innate Pharma, Marseille/FR
  • 11 Aix-Marseille University - Faculté de Médecine - Timone, Marseille/FR
  • 12 Faculté de Pharmacie, Marseille/FR


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Abstract 3MO


Prediction of ICIs efficacy in combination with chemotherapy remains an unmet need in patients (pts) with advanced NSCLC. The PIONeeR trial aims to predict response/resistance to PD1/L1 ICIs through a comprehensive multiparametric BMs analysis.


We focused on the first 155 ECOG PS0-1 pts treated with pembrolizumab in combination with platinum-based chemotherapy as 1st line therapy. Tumor tissue was collected at baseline and pts were re-biopsied at 6 weeks, and blood-sampled every cycle throughout 24 weeks. Immune contexture was characterized in tumor & blood through FACS for circulating immune cell subtypes quantification and endothelial activation, blood soluble factors dosage, dual- & multiplex IHC / digital pathology to quantify immune cells infiltrating the tumor, WES for TMB & ICI plasma pharmacokinetics, leading to 298 assessed BMs. Multimodal data integration through supervised machine learning (SML) was performed with bootstrap LASSO on a train (N=116) and a test dataset (N=39) to establish a BMs signature able to predict progression-free-survival (PFS) at 1 year.


Pts were mainly male (65%), smokers (96%) and <70yrs (82%). Tumors were mainly nonsquamous (87%) with PD-L1 TPS>1% in 38.4% of cases. With a median follow of 11.4 months, median PFS was 9.8 months and median overall survival was not reached. Using baseline data, SML identified a 15 BMs signature including classical (age, ECOG PS, PD-L1 TPS…) but also experimental parameters (CD45+ CD16+ cells density in tumor, CD45- CD73+ cells density in stroma, tissue factor and CD31+ CD41+ AnC+ microparticles blood concentrations…) with high predictive performance for PFS. On the train dataset, C-index was 0.79±0.13 and AUC was 0.81±0.28. These scores were confirmed on the test dataset, with C-index of 0.80 and AUC of 0.84.


The PIONeeR trial provides a novel comprehensive BMs analysis to establish predictive models of response/resistance to ICI in advanced NSCLC pts. Combination of BMs can individually predict outcomes of chemo-immunotherapy.

Clinical trial identification


Legal entity responsible for the study

Assistance Publique des Hôpitaux de Marseille.


French National Research Agency.


F. Monville, L. Ghezali, J. Fieschi-Meric: Financial Interests, Personal, Full or part-time Employment: Veracyte. All other authors have declared no conflicts of interest.

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