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Miguel Lazaro



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    EP1.14 - Targeted Therapy (ID 204)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.14-18 - NGS-Molecular Characterization of Lung Adenocarcinomas from Hispanic Patients: Level of Evidence for Therapeutic Actionability (ID 2599)

      08:00 - 18:00  |  Author(s): Miguel Lazaro

      • Abstract

      Background

      Several studies have shown that NSCLC genomic background among Hispanics differs from other populations, therefore genotyping tumors in order to assess their molecular profile is adamantly needed in the current era of targeted therapy. Panel-detected oncodriver mutations can drive therapeutic approaches, and can help classify the information in order to propose strong evidence-based interventions in treatment guidelines. In this study we sought to understand the landscape of genomic drivers in a cohort of patients with lung adenocarcinoma of Hispanic ancestry.

      Method

      Tumor samples were collected from 48 patients with lung adenocarcinoma from march 2017 until march 2019. Samples were submitted for testing to Foundation Medicine and hybrid capture NGS was performed.

      Result

      figura 1_fo.pngfigura 2_fo.pngA total of 282 samples were sent for evaluation, among which 48 (17%) with lung adenocarcinoma were tested by FoundationOne (FO) in tumor tissue. Among the patients included, 54.2% were men and 79.2% were >50 years of age. Most patients had a previous negative report for EGFR and ALK (in tumor tissue). Results for tumor mutation burden (TMB) were obtained from 48 (100%) samples. Median TMB was 4 mutations/Megabase (m/Mb). High TMB (>10 m/Mb) was identified in 9 (18.8%) samples. The most frequently detected alterations were in P53, KRAS and EGFR genes (Figure1). In terms of the level of evidence for therapeutic actionability, level-1 was 33.5 %, level-2 was 12.5%, level-3 14.6% and level-4 37.5%. (Figure 2).

      Conclusion

      Despite an initial assessment of actionable alterations (EGFR and ALK), through a NGS-approach we were able to detect a high amount of genomic alterations linked to a high-level of evidence for therapeutic actionability (33.5%), possibly due to higher sensitivity and a higher number of genes tested in the panel, increasing therapeutic options in this molecular-driven era. This research work was conducted with the support of Roche Foundation Medicine.

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    MA11 - Immunotherapy in Special Populations and Predictive Markers (ID 135)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Immuno-oncology
    • Presentations: 1
    • Now Available
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      MA11.03 - Pembrolizumab Plus Docetaxel Increases Progression-Free Survival Compared with Docetaxel Alone in Previously Treated Advanced Non-Small Cell Lung Cancer Patients (Now Available) (ID 2017)

      14:00 - 15:30  |  Author(s): Miguel Lazaro

      • Abstract
      • Presentation
      • Slides

      Background

      Immunotherapy is now the standard of care for non-small cell lung cancer patients without actionable mutations, due to a clear survival benefit in large phase III trials, further this benefit can be translated into the first-line setting, alone or in combination with chemotherapy. Nonetheless, due to several circumstances many patients do not receive immunotherapy as first-line. The effect of the combination therapy with pembrolizumab plus docetaxel in previously-treated NSCLC patients has not been prospectively assessed.

      Method

      In this phase II clinical trial, we evaluated the effect of a combination therapy with pembrolizumab plus Docetaxel (PD) compared with Docetaxel (D) for the treatment of advanced NSCLC patients who had progressed to previous lines of therapy. Primary endpoint was overall response rate (ORR); secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety profile.

      Result

      Eighty patients met the inclusion criteria and were enrolled in the study, among which 78 were randomized 1:1. Forty patients were allocated to receive PD, while thirty-eight were allocated to receive D. Baseline characteristics, including sex, age, tobacco index, performance status and EGFR mutation were well-balanced between both arms of the trial. We found a statistically significant difference in terms of ORR (42.5% vs. 15.8%; OR: 3.9 [95%CI: 1.34-11.5]; p=0.01), in patients receiving PD compared with D alone. Further, patients receiving PD had a significantly longer PFS compared with those receiving D monotherapy (9.5 months [95%CI: 4.2-NR] vs. 3.9 [95%CI: 3.2-5.7]; HR: 0.24 [95%CI: 0.13-0.46]; p<0.001). In the multivariate analysis the therapeutic intervention was an independently associated factor with better PFS (Figure). In terms of safety, a total of 22.5% vs. 5.3% of patients experienced any-grade pneumonitis in the PD and D arm of the trial respectively (p=0.048), while 27.5% vs. 16% experienced any-grade hypothyroidism (p=0.20). No new safety signals were identified.

      Conclusion

      Patients who receive the combination therapy have a significantly increased ORR and PFS, with a significant decrease in the hazard of progressing. This work was performed through a grant from MSD (Investigator Initiated Study). The sponsor did not have any role in the acquisition or interpretation of the data.


      pfs_figure 1.png
      Figure. Kaplan-Meier curve for the progression-free survival of patients in the experimental (P+D) vs. the control (D) arm of the trial.

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