Virtual Library

Start Your Search

Lionel Falchero



Author of

  • +

    MA14 - The Adequate MTarget Is Still the Issue (ID 140)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • +

      MA14.06 - Nintedanib-Docetaxel in 2nd Line Treatment in No Squamous Non-Small Cell Lung Cancer Patients, Refractory to First Line Treatment (GFPC02-15) (Now Available) (ID 558)

      15:45 - 17:15  |  Author(s): Lionel Falchero

      • Abstract
      • Presentation
      • Slides

      Background

      Second line chemotherapy used in advanced Non Small Cell Lung Cancer (NSCLC) have demonstrated a slight survival benefit in patient refractory to a first line platinum based doublet chemotherapy. In exploratory analysis, Nintedanib in combination with docetaxel have shown interesting result in second line setting for refractory NSCLC patients.

      Objective: To assess the efficacy in terms of progression-free survival (PFS) of the nintedanib - docetaxel combination in second-line treatment in refractory no squamous NSCLC (NsqNSCL) patients

      Method

      This prospective, multicentric open-label phase II trial, included patients with advanced Nsq NSCLC (EGFR, ALK wild-type), PS 0-1, progressing during the first four cycles of cisplatin-based induction chemotherapy. Patients received Nintedanib (200 mg X2 /d d2-d20)- Docetaxel (75 mg/m2 d1-d21) combination until progressive disease or unacceptable toxicity.

      The primary endpoint was the PFS rate at 12 weeks. Secondary endpoints included median PFS, median overall survival (OS), overall response rate (ORR) and tolerability. Based on a A’Hern’s single-stage phase II design trial (sample size determination is based on exact binomial distribution), the Nintedanib-Docetaxel strategy will be rejected if the primary endpoint was below 22/53 patients at the end of study.

      Result

      The analysis included 53 evaluable patients managed in 21 centers; last patient included at the end of January 2019. Mean age 58.4 years, male 73 %, adenocarcinoma 97.5%, current/former smokers: 42/50 %, PS 0/1: 25%/75%; weight loss >5% : 19%, stage IV: 100% (38% with brain metastasis, median metastasis 2). All patients received for induction chemotherapy, a platin doublet (22% with bevacizumab), number of cycle 1-2/ 3-4: 57%/ 43%.

      Interim analysis reviewed by the independent committee conducted as planned, after the 27 first inclusions concluded that there was no sign of unexpected toxicity (adverse events grade 3-4 :22%, grade 5 :0%) or futility (9 patients meet primary end point on 25 evaluable). The results of the final analysis on the whole population (PFS at 12 weeks (primary end point), median PFS, median OS and toxicity) will be presented at the meeting

      Academic grant from Boehringer Ingelheim

      Conclusion

      Section not applicable

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    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
    • +

      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): Lionel Falchero

      • 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

  • +

    P2.01 - Advanced NSCLC (ID 159)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
    • +

      P2.01-96 - Response to Anti-HER2 Afatinib in a Case of Invasive Pulmonary Mucinous Adenocarcinoma with a SLC3A2-NRG1 Fusion (ID 205)

      10:15 - 18:15  |  Author(s): Lionel Falchero

      • Abstract
      • Slides

      Background

      Background : Neuregulin 1 gene (NRG1) fusions such as SLC3A2-NRG1 have been identified in 6,7% of invasive pulmonary mucinous adenocarcinoma (IMA). This fusion leads to ErbB2 and ErbB3 pathway activation. Theoretically a matched targeted therapy may be afatinib, an oral irreversible ErbB-family inhibitor.

      Method

      Methods : We present the case of a 80 year-old non smoker caucasian female with breathless at rest, bronchorrhea, fever, bilateral ground glass opacities and right lower lobe atelectasia. Body CT scan and PET-scanner revealed hypermetabolic multifocal lung involvement. Cytologic examination of bronchioloalveolar lavage revealed adenocarcinomatous cells compatible with IMA. She received first-line gefitinib 250mg per day, antibiotics and solumedrol. After a clinical improvement of 15 days, cough and hypoxemia worsened and CT scan showed pulmonary opacities progression. A SLC3A2(e5)-NRG1(e6) gene fusion was identified with a targeted RNA sequencing performed on cytologic samples (Panel « FusionPlex CTL Kit », ArcherDx). The sample was negative for EGFR ex18 to 21, KRAS, BRAF, PIK3CA, ERBB2, MET mutations. Afatinib 30mg orally once daily was started. At 8-week follow-up, the patient reported resolution of cough, bronchorrhea, hypoxemia and chest CT showed significant improvement of ground glass opacities in the left lower lobe. The clinical response was sustained to week 16, when her bronchorrea and hypoxemia worsened and CT scan showed progression despite an increasing dosage of afatinib at 40mg once daily. She subsequently received carboplatine- paclitaxel- bevacizumab. A progression eventually occurred after 4 months. We rechallenge afatinib 30mg orally once daily and a clinical and imaging response is still ongoing after 8 weeks.

      Result

      Results: The clinical efficacy of afatinib in this case was suggestive of an on target effect of afatinib, with rapid clinical improvement and radiographic response despite a disease control shorter than 16 weeks.

      Conclusion

      Conclusion: This report offers some evidence of the activity of afatinib in NRG1 gene fusion-positive lung cancer.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

    P2.14 - Targeted Therapy (ID 183)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
    • +

      P2.14-65 - Efficacy of Dabrafenib Plus Trametinib Combination in Patients with BRAF V600E–Mutant NSCLC in Real World Setting (ID 307)

      10:15 - 18:15  |  Author(s): Lionel Falchero

      • Abstract
      • Slides

      Background

      Dabrafenib plus trametinib (D-T) combination is approved in Europe Union for BRAFV600E–mutant metastatic non-small cell lung cancer(NSCLC) but there is few published data’s on this efficacy and tolerance outside clinical trail results.

      Objective: to assess efficacy and tolerance of D-T in real world setting.

      Method

      Retrospective, multicentric study including BRAF V600E-positive advanced NSCLC receiving D-T outside a clinical trial. Overall survival (OS) and progression free survival (PFS) were analyzed in all population and according lines of D-T treatment (first line treatment or subsequent line treatments).

      Result

      the analysis included 40 BRAF V600E advanced NSCLC patients managed in 14 centers; at diagnosis: mean age 71 ±9.6 years , female 55 %, adenocarcinoma 95 %, currents/formers smokers 17.5%/50 %, At D-T initiation: PS 0-1/2 or+: 86.8%/13.2% , loss weight> 5%: 24%, symptomatic disease: 92%, stage IV: 95% , mean metastatic site: 2.3 (main metastatic sites: pleura: 46%, bone: 33%, respectively).Mean line of treatment before D-T: 1.5. D-T was a first line treatment in 22.5 %, second line or more 77.5% (25% received one BRAF TKI before). Median time between diagnosis and D-T treatment was 0.7 [95%CI: 0.2-1.3] months in first line setting and 17.3 [95%CI: 10.8-27.2] months.

      At the time of analysis 67.5% patients were in treatment with D-T and median follow up since beginning of D-T treatment was 8.7[95%CI: 5-12]months in whole population [7,5, 95%CI: 1-12.3]months for patients treated in first line). D-T dose was modified for 32.5.0% of the patients and definitively discontinued for 12,5 % because of severe adverse events.

      Median PFS and OS were not reach and follow up is continued.

      The mature results of PFS and OS (whole population and subgroups) will be showed to the WLCC meeting.

      Conclusion

      Section not applicable

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.