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Marco Angelo Burgio



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    EP1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 206)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.16-04 - Real World Clinical Outcomes for Metastatic Non-Small Cell Lung Cancer (mNSCLC) at IRST Italy (Now Available) (ID 2307)

      08:00 - 18:00  |  Author(s): Marco Angelo Burgio

      • Abstract
      • Slides

      Background

      This study sought to evaluate the real word clinical outcomes concerning overall survival (OS) for patients in first-line treatment for metastatic non-small cell lung cancer (mNSCLC) prior to the availability of immunotherapies in any line.

      Method

      Patients who received systemic anti-cancer treatment for mNSCLC at IRST between Jan2014-Jun2017 with a minimum follow-up of six months were included. The clinical dataset was obtained from data registered in electronic health records maintained during clinical practice. OS was defined as the interval from start of first-line therapy until death or follow-up end, whichever occurred first. Death information was detected from mortality register. OS was estimated using the Kaplan-Meier method stratified by type of first-line treatment.

      Result

      Among the 428 first-line patients analyzed, 64.5% were over 65 years old and 62.6% were men (Table 1). A total of 79.0% patients had non-squamous histology whereas 15.0% had squamous histology, with the remaining 6% other histologies. EGFR mutation was detected in 15.7% and ALK translocation in 8.4% of patients. In the first-line the majority (57.0%) of patients received platinum-doublet (mainly platinum+pemetrexed) while single agent chemotherapy was administered in 23.8%, whereas 10.0% received targeted therapy. Conversely overall 9.0% were enrolled in clinical trials, while 0.2% received Immunotherapies. Median OS was 19.9 months (95%CI:9.2-21.7) with targeted therapy, 8.5 months (95%CI:4.8-13.6) for patients enrolled in clinical trials, 6.4 months (95%CI:5.8-7.6) with platinum-doublet and 4.4 months (95%CI:3.7-5.7) with single agent chemotherapy. A total of 34.5% of first-line patients continued to receive second-line treatment.

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      Conclusion

      In this analysis prior to the introduction of immunotherapies for NSCLC, OS was similar to real world OS in the published literature. The survival was worse in the single agent chemotherapy group while it is superior in platinum doublets group. Overall survival was longest in patients treated with targeted therapy.

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    OA14 - Update of Phase 3 Trials and the Role of HPD (ID 148)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Immuno-oncology
    • Presentations: 1
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      OA14.04 - Five-Year Outcomes From the Randomized, Phase 3 Trials CheckMate 017/057: Nivolumab vs Docetaxel in Previously Treated NSCLC (ID 894)

      11:30 - 13:00  |  Author(s): Marco Angelo Burgio

      • Abstract
      • Slides

      Background

      Historically, outcomes for advanced non-small cell lung cancer (NSCLC) have been poor, with 5-year survival rates < 5% with conventional chemotherapy. Nivolumab, a programmed death-1 (PD-1) inhibitor, was approved in 2015 for patients with previously treated advanced NSCLC based on two randomized phase 3 trials, CheckMate 017 (NCT01642004; squamous) and CheckMate 057 (NCT01673867; non-squamous), which demonstrated improved overall survival (OS) vs docetaxel. We report 5-year pooled efficacy and safety from these trials, representing the longest survival follow-up for randomized phase 3 trials of an immune checkpoint inhibitor in advanced NSCLC.

      Method

      Patients (N = 854; CheckMate 017/057 pooled) with advanced NSCLC, ECOG performance status (PS) ≤ 1, and progression during or after first-line platinum-based chemotherapy, were randomized 1:1 to nivolumab 3 mg/kg Q2W or docetaxel 75 mg/m2 Q3W until progression or unacceptable toxicity. After completion of the primary analyses, patients in the docetaxel arm no longer receiving benefit could cross over to receive nivolumab. OS was the primary endpoint for both studies.

      Result

      At 5-year follow-up, 50 nivolumab patients and 9 docetaxel patients were alive. Baseline characteristics of 5-year survivors in both arms were similar to the overall population and patients who survived < 1 year, except for a higher percentage of patients with ECOG PS 0 or tumor programmed death ligand-1 (PD-L1) expression ≥ 1% on nivolumab and ECOG PS 0 and Stage IIIB NSCLC on docetaxel. Nivolumab continued to show long-term OS and progression-free survival (PFS) benefit vs docetaxel with 5-year OS rates 13% vs 3% (HR, 0.68 [95% CI, 0.59–0.78]) and PFS rates 8% vs 0% (0.79 [0.68–0.92]). OS benefit with nivolumab vs docetaxel was observed across subgroups including patients with tumor PD-L1 expression < 1%, baseline liver and adrenal metastases, neutrophil-to-lymphocyte ratio < median, lactate dehydrogenase ≥ upper limit of normal or no baseline proton-pump inhibitor use. Among patients with an objective response to nivolumab (20%) or docetaxel (11%), 32% remained in response at 5 years vs none on docetaxel, with a median duration of response of 19.9 vs 5.6 months, respectively. Of the 5-year nivolumab vs docetaxel survivors, 36% vs 0% were on study drug, 20% vs 67% received subsequent immunotherapy (on or off study), and 10% vs 0% were off study drug, progression free, with no subsequent therapy. No new safety signals were observed with longer follow-up. Between 3 and 5 years’ follow-up, 8 of the 31 (26%) nivolumab-treated patients reported a treatment-related adverse event, 1 (3%) grade 3–4. The most common select adverse events (events with a potential immunological cause) were related to skin, in 4 (13%) patients, none of which were grade 3–4.

      Conclusion

      CheckMate 017 and 057 are the first phase 3 trials to report 5-year outcomes for a PD-1 inhibitor in previously treated advanced NSCLC, demonstrating a greater than 4-fold increase in 5-year OS rates with nivolumab (13%) over docetaxel (3%). Nivolumab remained well tolerated with no new safety signals.

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