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Charu Aggarwal



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    MA15 - Colliding Approaches - EGFR and Immunotherapy (ID 916)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 13:30 - 15:00, Room 107
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      MA15.08 - Discussant - MA 15.05, MA 15.06, MA 15.07 (ID 14643)

      14:15 - 14:30  |  Presenting Author(s): Charu Aggarwal

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    OA07 - Oligometastasis: What Should Be the State-Of-The-Art? (ID 905)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Oligometastatic NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 15:15 - 16:45, Room 107
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      OA07.01 - Phase II Study of Pembrolizumab for Oligometastatic Non-Small Cell Lung Cancer (NSCLC) Following Completion of Locally Ablative Therapy (LAT) (ID 12590)

      15:15 - 15:25  |  Author(s): Charu Aggarwal

      • Abstract
      • Presentation
      • Slides

      Background

      Patients (pts) with oligometastatic NSCLC may benefit from LAT (e.g., surgery, stereotactic radiation (SRT)). It is unclear if systemic therapy can provide benefit after LAT. We completed a Phase II study evaluating the efficacy of pembrolizumab after LAT, hypothesizing that immunotherapy would be effective in the setting of a minimal disease burden.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Eligibility stipulated oligometastatic NSCLC (up to 4 sites) with completion of LAT to all known sites of disease. Within 4-12 weeks of completing LAT, pts began pembrolizumab 200 mg every 21 days for 6 mos, with a provision to continue for up to a year in the absence of progression (PD) or toxicity. Progression-free survival (PFS) and overall survival (OS) were measured from the start of LAT. A sample size of 42 pts would provide 80% power for a test at 5% 1-sided type I error to increase PFS to >=10 mos compared to a historical control PFS of 6.6 mo.

      4c3880bb027f159e801041b1021e88e8 Result

      Since January 2015, 45 pts have been enrolled. Median age is 64 years; 53% male; 89% Caucasian; 89% current and former smokers. Most common metastatic sites are lung (16 pts), brain (18), liver (9), and bone (9). LAT included surgery (30 pts), SRT (30), and chemoradiotherapy (23). Adverse events have been mostly mild. There were two episodes of Grade 3 pneumonitis, two episodes of Grade 3 colitis, and one episode of Grade 3 adrenal insufficiency. Median follow-up from start of LAT is 20.1 mos. To date, 19 pts have had PD or died. Median PFS was 25 mos. PFS rates (+ SE) at 12, 18 and 24 mos are 72%+7%, 54%+9% and 50%+9%, with 10 free of PD/death beyond 24 mos. To date, 10 pts have died. Median OS has not yet been reached. OS rates (+ SE) at 12, 18 and 24 mos are 91%+4%, 82%+7% and 73%+8%, with 14 pts alive beyond 24 mos. Median PFS was 16.9 mos for pts with metachronous disease (n=33), not yet reached for pts with synchronous disease (n=12). Median OS has not yet been reached in either group.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Pembrolizumab after LAT for oligometastatic NSCLC is feasible and well tolerated. PFS appears quite favorable, preliminarily Final analysis will be performed September 2018. Updated survival estimates and biomarker data will be presented.

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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-64 - Impact of STK11 Co-Mutation on Outcomes Following Immunotherapy Among Patients with TP53 and KRAS Mutated Stage IV NSCLC (ID 12581)

      16:45 - 18:00  |  Author(s): Charu Aggarwal

      • Abstract
      • Slides

      Background

      Mutations in LKB1/STK11 may predict a poor response to immunotherapy in NSCLC. We previously showed that pretreatment neutrophil-to-lymphocyte ratio (NLR) >5 predicted a poor response to immunotherapy in NSCLC. We evaluated the impact of STK11 mutation (MT) alone, and co-existing MTs in KRAS and TP53 on outcomes in patients (pts) treated with immunotherapy at the University of Pennsylvania. The role of NLR was also evaluated.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with metastatic NSCLC that underwent NGS and who received 2nd-line immunotherapy were identified (2/2013 – 12/2016). Patient demographics, tumor characteristics, and outcomes were analyzed from the electronic medical record. Chi-square and the Wilcoxon Rank-Sum test were used to assess correlation between NLR and MT status. Median overall survival (mOS) and median progression free survival (mPFS) times are estimated from Kaplan-Meier curves. A Cox proportional hazard model (HR) was used to assess the effect of mutation status on survival outcomes.

      4c3880bb027f159e801041b1021e88e8 Result

      110 pts were included with the following MT status: 5 STK11, 16 KRAS, 29 TP53, 13 KRAS/TP53, 7 KRAS/STK11, 9 TP53/STK11, 7 KRAS/TP53/STK11, 24 no STK11, KRAS or TP53 MT. In univariate and multivariable analyses, STK11 MT was not independently associated with mPFS or mOS after immunotherapy. Among pts with TP53 MT, the presence of a STK11 MT was associated with improved mPFS (4.3 vs. 2 mo, HR 0.416, p=0 .035, (95% CI 0.18 –0.94)) and statistically similar mOS (13.1 vs 6.8 mo, HR 0.43, p=0.09 (95%CI 0.16–1.14)) compared with STK11 wild type (WT). Conversely, among pts with KRAS MT, the presence of a STK11 MT was associated with similar mPFS (2.2 vs 2.8 mo, HR 1.64, p=0.247 (95% CI 0.7–3.8)) and mOS (3.5 vs 7.7 mo, HR 2.3, p=0.09 (0.16–1.14)) compared with STK11 WT. NLR did not correlate with MT status. After stratifying for NLR (<5 and >5), the effect of STK11 MT on mOS in the TP53 MT group was amplified in pts with NLR<5 (n=46, HR 0.05, p=0.021, 95% CI 0.004-0.63) compared to TP53 MT with STK11 WT (HR 4.3, p=0.036 (95% CI 1.1-16.9)).

      8eea62084ca7e541d918e823422bd82e Conclusion

      STK11 mutation status alone does not correlate with pre-treatment NLR and is not independently associated with survival outcomes after immunotherapy. PFS following immunotherapy is improved in patients with co-existing TP53 and STK11 MT compared to STK11 WT. An OS benefit after immunotherapy is amplified in patients with NLR<5, TP53 MT, and STK11 co-MT.

      * Authors Marmarelis and Bange contributed equally

      6f8b794f3246b0c1e1780bb4d4d5dc53

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