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Desiree Hao



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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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      MA11.04 - Platinum Doublet + Durvalumab +/- Tremelimumab in Patients with Advanced NSCLC: A CCTG Phase IB Study - IND.226 (Now Available) (ID 927)

      14:00 - 15:30  |  Author(s): Desiree Hao

      • Abstract
      • Presentation
      • Slides

      Background

      Studies of single agent immune checkpoint inhibitors with platinum-based chemotherapy in non-small cell lung cancer (NSCLC) have demonstrated survival benefit over chemotherapy alone. The primary objective of this multi-centre study was to evaluate the safety and tolerability of durvalumab (Du), a PD-L1 inhibitor, +/- tremelimumab (Tr), a CTLA-4 inhibitor, with one of four standard platinum-doublet regimens (pemetrexed (pem), gemcitabine, etoposide (each with cisplatin or carboplatin) or nab-paclitaxel (with carboplatin)), in order to establish a recommended phase II dose (R2PD) for each combination. This abstract updates the results in the NSCLC cohort in this study.

      Method

      Patients (pts), regardless of tumour PD-L1 status, were enrolled into one of six dose levels (Table 1). Dose escalation was according to a Rolling Six type design. Concurrent enrollment of cohorts was allowed. ind 226 abstract wclc methods.png

      Result

      Seventy-three pts (median age=63 (range 34-80); 52% female; 77% non-squamous) were enrolled. The majority of drug-related adverse events (AEs) were grade 1 or 2. Most AEs were related to chemotherapy; other AEs were chemotherapy or immune-related (renal, hepatic, skin and pulmonary toxicity). AEs that were considered related to Du or Tr (immune related AEs (irAEs)) were mainly grade 1 or 2. The most common irAEs were fatigue (64%), rash/itch (42%), diarrhea/colitis (34%), anorexia (22%), thyroid dysfunction (19%), and nausea/vomiting (21/12%). The most common grade 3 or 4 irAEs were diarrhea/colitis (11%), fatigue (10%), and rash (5%). No treatment related grade 5 toxicities were reported. Twenty pts (27%) discontinued treatment due to an AE. Twelve pts (16%) discontinued treatment for toxicity related to D+/-T. Objective response rate (ORR) was 50.7% (95% CI = 38.7-62.6%). Median progression free survival (mPFS) was 6.5 months (95% CI = 5.5-9.4). Median overall survival (mOS) was 19.8 months (95% CI = 14.8-not yet reached). ORR was similar for all levels of PD-L1 staining including PD-L1 negative patients. ORR for pts with EGFR mutations (N=5) was similar to the ORR of wild type pts. Exploratory analyses suggest mPFS and mOS were longer in patients who experienced irAEs.

      Conclusion

      In this PD-L1 unselected patient population, Du and Tr can be safely combined with full doses of platinum-doublet chemotherapy. The ORR, mPFS and mOS are similar to results reported from other immunotherapy + chemotherapy combination trials. A randomized trial, CCTG BR.34, is evaluating the incremental benefit of adding platinum doublet to Du+Tr.

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-118 - Overall Survival in Pts with EGFRm+ NSCLC Receiving Sequential Afatinib and Osimertinib: Updated Analysis of the GioTag Study (ID 2211)

      09:45 - 18:00  |  Author(s): Desiree Hao

      • Abstract
      • Slides

      Background

      With three generations of EGFR tyrosine kinase inhibitors (TKIs) now available for the treatment of EGFR mutation-positive (EGFRm+) NSCLC, it will be important to identify the optimal sequence of EGFR TKIs to maximise survival. The observational GioTag study (NCT03370770) investigated outcomes in patients with EGFRm+ NSCLC who were treated with sequential afatinib and osimertinib in a ‘real-world’ clinical setting, including patients with poor prognosis (ECOG PS ≥2: 15%; stable brain metastases: 10%).1 Time to treatment failure (TTF) was encouraging (overall: 27.6 months; Del19-positive patients: 30.3 months; Asians: 46.7 months). In this updated analysis, we report OS and updated TTF.

      Method

      Data were retrospectively collected between Dec 2017 and June 2018 for 203 pts with EGFRm+ (Del19, L858R) NSCLC who had T790M-positive disease after first-line afatinib and subsequently received osimertinib. TTF was the primary outcome; OS analysis was exploratory. Data were collected from electronic health records (EHRs; n=126) or medical charts (n=77). For logistical reasons, this interim analysis includes updated data (as at April 2019) from patients with available EHRs (all from USA; n=94); final analysis incorporating updated data from manual chart reviews is anticipated in early 2020.

      Result

      After a median follow-up of 30.3 months, median OS was 41.3 months (90% CI: 36.8–46.3) in the overall dataset (n=203) and 45.7 months (90% CI: 45.3–51.5) in Del19-positive patients (n=149); 80% of patients were alive after 2 years. OS in Asians was immature. Updated median TTF was 28.1 months (90% CI: 26.8–30.3) in the overall dataset, and 30.6 months (90% CI: 27.6–32.0) in Del19-positive patients. Outcomes were not affected by afatinib starting dose. Median TTF with osimertinib was 15.6 months (90% CI: 13.817.1) in the overall dataset, and 16.4 months (90% CI: 14.917.9) in Del19-positive patients.

      Conclusion

      Sequential afatinib and osimertinib is associated with encouraging OS and TTF in pts with EGFR T790M-positive NSCLC, especially in Del19-positive patients, indicating that the sequential regimen is a feasible option in this setting. Of note, prior treatment with afatinib did not preclude prolonged TTF with second-line osimertinib (15.6 months overall; 16.4 months in Del19-positive patients). The final analysis will provide further insights into the long-term OS of patients treated with sequential afatinib–osimertinib, including Asians.

      1. Hochmair MJ, et al. Future Oncol. 2018;14:2861–74.

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    P1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 186)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.16-33 - From a Systematic Review to Real World Evidence: Integrating Gender as a Clinical Risk Factor in NSCLC  (ID 2730)

      09:45 - 18:00  |  Author(s): Desiree Hao

      • Abstract

      Background

      Gender-based disparities in NSCLC experience have been widely discussed in the literature. The recognition of gender as a confounder in clinical practice remains uncertain. Confirming its impact on prognosis encourages personalized interventions in an effort to improve survival for NSCLC patients. Since best prevention programs are derived from findings established from multiple-evidence based analysis, the influence of gender on the observed disparities in NSCLC was explored using worldwide evidence and single institute experience. A systematic review was initially carried out to synthesize the evidence on a global scale to confirm the influence of gender-discrepancies in NSCLC incidence rates. Findings were compared and contrasted using a single cancer institute to highlight potential trends related to the different data.

      Method

      We identified relevant articles published in English using Medline between 1996 and 2016. Pooled standardized-incidence data was analyzed using a semi-parametric longitudinal regression model to estimate changes in NSCLC incidence as a function of time, histology and gender. A heat map was also designed to illustrate the global trend of NSCLC captured in the published articles. Findings of this review were evaluated to confirm the influence of gender on NSCLC trends and outcomes using a single center record. A retrospective analysis was performed using the Glans-Look Database (GLD) for patients diagnosed between 1999 and 2015. The Kaplan-Meier estimator of cumulative survival was conducted to analyze treatment outcomes of patients using SPSS and R. Statistical significance was set at 95% confidence level (p < 0.05).

      Result

      Our systematic review demonstrated gender-based disparities over time, and the main effect of gender on incidence rates is significant (p=0.01). Visualizing global trends of NSCLC’s histology confirm that women are prone to develop ADC. GLD data verifies the influence of gender, where women were more prone to develop ADC (49%), and the relative changes of its rate over 15 years increased significantly compared to men (58% vs 32%, P<0.02). Survival rates were also predisposed by gender, where female ADC mOS exceeded that of males in overall comparisons (17.6 vs. 12.2, p=0.047).

      Conclusion

      Our findings serve as a basis to resolve the inherent controversies in the research, and highlight the importance of gender as a clinical risk factor. Therefore, it is important to include gender as a prognostic tool to improve screening programs and promote tailored therapies for better outcomes. Biological, social, or a combination of factors could also influence the differences observed and warrant further investigation.