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Stéphane Hominal
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EP1.01 - Advanced NSCLC (ID 150)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.01-05 - EGFR-2013-CPHG, a Real-World Study of EGFR Mutant Advanced Non-Small-Cell Lung Cancer Patients Treated with Erlotinib (ID 892)
08:00 - 18:00 | Author(s): Stéphane Hominal
- Abstract
Background
Erlotinib (E) is a first-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor labelled in France and effective as a first-line treatment in advanced non-small-cell lung cancer (NSCLC). E has demonstrated a better efficacy than chemotherapy in EGFR mutant NSCLC in phase III trials.
Method
We undertook a multicentric study in 42 French Nonacademic Hospital Centres. Patients aged 18 years and older with histologically confirmed stage IIIB or IV NSCLC and harboring a confirmed activating mutation of EGFR received oral E (150 mg/day). We report here patient characteristics, progression-free survival (PFS), overall survival (OS), and safety data. Statistical analyses by R software were based on a Cox model and Kaplan-Meier method.
Result
Between April 1st, 2014 and March 31st, 2016, 184 patients were recruited: mean age = 72 years old, 125 (69.5%) female, 158 (90.8%) Caucasians, 112 (63.6%) non-smokers, 167 (94.9%) adenocarcinoma (21 stage IIIB and 156 stage IV), 127 (65.6%) ECOG 0-1, 40 (26%) brain metastasis at inclusion and 75 (42.4%) were treated by E in second- or latter line. 179 patients were included in the PFS and OS analysis. Median follow-up was 23.8 months, median PFS was 11.7 months and median OS was 25.8 months. Median survival rates at one year were 48.6% for PFS and 75% for OS. Risk of death was not correlated with brain metastasis (HR=1.15, IC95:0.67-1.97, p=0.296) but with ECOG = 2 (HR=4.55, IC95:2.05-10.10, p<0,001). E had a manageable safety profile (7.7% grade 3-4 adverse events at 6 months) and no new safety signals were identified.
N % Patients 184 Mean age (years) 72 Sex Males
Females
59
125
30.5
69.5
Race Caucasians 158 90.8 Smoking status Non-smokers 112 63.6 Histological type Adenocarcinoma 167 94.9 Staging Stade IIIB
Stade IV
21
156
ECOG 0 or 1 127 65.7 Brain metastases at inclusion 40 26 Second-lind therapeutic strategy and more Erlotinib 75 42.4 Progression-free survival and overall survival 179 Median Progression-free survival (Months)
Median Overall Survival (Months)
11.7
25.8
Conclusion
Data from EGFR-2013-CPHG real-world study are consistent with the efficacy and safety of E in EGFR mutant NSCLC patients seen in phase III clinical trials.
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P1.04 - Immuno-oncology (ID 164)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.04-30 - Pioneer Study: Precision Immuno-Oncology for Advanced Non-Small Cell Lung Cancer Patients with PD1/L1 ICI Resistance (ID 1865)
09:45 - 18:00 | Author(s): Stéphane Hominal
- Abstract
Background
In the management of advanced Non-Small Cell Lung Carcinoma (NSCLC), both PD1/L1 immune checkpoint inhibitors (ICIs) have been shown to increase overall survival (OS) over standard second-line chemotherapy. While this long-term increase in OS is driven by about 20% of patients, others display disease progression during the first weeks (w.). PIONeeR aims to understand, through a strategy based on a comprehensive biomarkers assessment, and overcome, through rescue IO strategies, the resistance to ICIs.
Method
Stage IV or recurrent NSCLC patients (n=450), with an archived pre-ICI tumor block, planned for a standard 2nd or 3rd line ICIs monotherapy, will be screened. If eligible, after signing an informed written consent, they will be blood-sampled, every cycle throughout the 18 w. post C1D1, and systematically be re-biopsied (primitive or metastasis tumor) at 6 w. of treatment. Efficacy of ICIs will be assessed by RECIST, after 6, 12 and 18 w. Feces will be self-collected by patients, before and during ICIs, to analyze impact of gut microbiome in resistance to ICIs. Characterization of the specific immune contexture of each patient to potentially predict the efficacy of ICIs will be based on the investigation of tumors and their microenvironment (Immunoscore® IC & Multiplex ImmunoHistoChemistry, Tumor Mutational Burden –T cell clonality- ctDNA investigation), effector immune cells, cytokines and endothelial activation (ELISA-Flow cytometry). Protocol’s legal and ethical authorizations were obtained on February 2018 (NCT03493581), patient inclusions were enhanced on April 2018 with the activation of 3 main centers; 10 satellites centers were opened at Q4 2018, inclusions are expected to be completed at Q4 2020. Patients who will progress between 6 and 18 w. (n=150) will be randomized within a precision immuno-oncology experimental masterprotocol using a Bayesian, adaptive design (4 combinations of PDL1i and NKG2Ai, STAT3i, ATRi or CD73i or a control arm). Legal authorizations were obtained on December 2018 (NCT03833440), the inclusion period is expected to last 24 months, from the beginning of Q2 2019.Descriptive statistics will be used to characterize distributions of marker’s expression and to evaluate their predictive value on treatment response and prognostic value on Progression Free Survival., in both protocols. The primary endpoint of the randomized clinical trial is the 12-week Disease Control Rate, assessed in each arm of treatment.
Result
Section not applicable
Conclusion
Section not applicable
