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B. Korytowsky



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    MA14 - Immunotherapy in Advanced NSCLC: Biomarkers and Costs (ID 394)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
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      MA14.09 - Demonstrating Life Expectancy Gains with Immuno-Oncology (IO) Therapies (ID 4634)

      16:00 - 17:30  |  Author(s): B. Korytowsky

      • Abstract
      • Presentation
      • Slides

      Background:
      Immuno-oncology (IO) therapies offer the possibility of long-term survival to metastatic cancer patients. Prior analyses have shown that lung cancer reduces life expectancy by an average of 11.8 years (Burnet NG, et al. Br J Cancer. 2005;92:241‒245.). We aimed to investigate the impact of IO therapies on life extension of patients with non-small cell lung cancer (NSCLC).

      Methods:
      We used The Health Economics Medical Innovation Simulation (THEMIS) alongside available clinical trial data to estimate the anticipated increase in NSCLC patient survival post-diagnosis resulting from the introduction of IO therapy. THEMIS is an established microsimulation with a 50-year time horizon that tracks a representative sample of patients aged ≥51 years to project longevity. These outcomes were estimated for metastatic NSCLC patients under a pre-IO scenario and compared to a post-IO scenario where IO is available for either first- or second-line treatment. Patients were classified as either heavy, medium, or light responders, corresponding to reductions in mortality hazards of 96.5%, 64.4%, and 0%, respectively, based on extrapolations of clinical trial results for nivolumab (see table). Health state transitions probabilities and medical expenditures were estimated from nationally representative datasets. Mortality and disease stage were estimated using the Surveillance and Epidemiology End Results (SEER) database.

      Results:
      In the pre-IO simulation, metastatic NSCLC patients lose 11.3 years of life (comparable with the published 11.8 years). The results from the post-IO scenarios are shown in the table. For comparison, SEER data suggest that survival in metastatic NSCLC patients has only increased by 0.3 years since 1998.

      Population Heavy Responder Prevalence Medium Responder Prevalence Heavy Responder Hazard Reduction Medium Responder Hazard Reduction Light Responder Hazard Reduction Additional Life Years
      Second-line monotherapy, All patients 20% 30% 96.5% 64.4% 0% 2.1
      First-line monotherapy, PD-L1 >1% 30% 40% 96.5% 64.4% 0% 3.25
      First-line monotherapy, PD-L1 >50% 50% 40% 96.5% 64.4% 0% 4.72
      First-line combination therapy, PD-L1 >1% 60% 30% 96.5% 64.4% 0% 4.22
      First-line combination therapy, PD-L1 >50% 100% 0% 96.5% N/A N/A 7.06


      Conclusion:
      Current IO therapies represent a significant step towards extending life expectancy for metastatic NSCLC patients.

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    P3.02c - Poster Session with Presenters Present (ID 472)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02c-026 - Is Nivolumab Safe and Effective in Elderly and PS2 Patients with Non-Small Cell Lung Cancer (NSCLC)? Results of CheckMate 153 (ID 5383)

      14:30 - 15:45  |  Author(s): B. Korytowsky

      • Abstract
      • Slides

      Background:
      CheckMate 153 (NCT02066636) is an ongoing, predominantly community-based, phase 3B/4 safety study of nivolumab in patients with previously treated metastatic NSCLC in the US/Canada. Here we report safety, efficacy, and patient-reported outcome (PRO) data for subgroups of patients aged ≥70 years or with a poor baseline ECOG PS (PS2).

      Methods:
      Patients were enrolled in four subgroups based on histology and prior regimen number; one subgroup enrolled patients with squamous (SQ) or non-SQ NSCLC, PS2, and ≥1 prior therapies. Data on elderly patients were pooled across subgroups. The primary objective was assessment of high-grade (grade 3–4 and 5) select (those with a potential immunologic cause) treatment-related AE (TRAE) incidences. Exploratory endpoints included efficacy, biomarkers, pharmacokinetics, and PROs.

      Results:
      Of 1,308 patients, 520 (40%) were aged ≥70 years and 108 (8%) had PS2. TRAE incidences for the age and PS subgroups were comparable with those for the overall population (table), as were select TRAE incidences for the subgroups. Estimated 6-month OS was lower with PS2 than PS0‒1, but similar between age subgroups and the overall population (table). Early PRO data revealed significant improvements overall in both age subgroups using LCSS and EQ-5D VAS, with younger patients showing greater improvement on some scales. Patients with SQ disease and PS2 generally reported stable quality-of-life/symptom control, whereas patients with non-SQ disease had statistically significant improvements on most scales. Updated data, including 1-year OS, will be presented.

      Conclusion:
      In this large study of advanced, previously treated, predominantly community-based patients with NSCLC, the nivolumab safety profile for age and PS subgroups was comparable with those for the overall population and from prior nivolumab NSCLC studies. OS was similar in younger and older patients, but lower in PS2 patients at early time points. Nivolumab appears to have similar risks/benefits in older and poorer PS patients as in the general population. Figure 1



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