Author of

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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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    P1.01-108 - PACIFIC-6: A Phase II Study of Durvalumab Following Sequential Chemoradiotherapy in Patients with Stage III, Unresectable NSCLC (ID 2318)

    09:45 - 18:00  |  Author(s): Ugochi Emeribe
    • Abstract
    • Slides

    Background
    

    Non-small cell lung cancer (NSCLC) represents 85% of all lung cancers, with ~30% of patients (pts) presenting with Stage III disease. Platinum-based chemoradiotherapy (CRT) has historically been the standard of care (SoC) in this setting, but with poor long-term outcomes. Durvalumab is a selective high-affinity, human IgG1 monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80. The phase III PACIFIC trial assessed durvalumab vs placebo in pts with locally advanced, unresectable, Stage III NSCLC, who did not progress following ≥2 overlapping cycles of platinum-based concurrent CRT (cCRT) (Antonia et al, NEJM 2017; 2018). Significant improvements in progression-free survival (PFS) and overall survival (OS) were observed with durvalumab (HR for PFS, 0.52; 95% CI 0.42–0.65; P<0.001; HR for OS, 0.68; 99.73% CI 0.47–0.997; P=0.0025). This data, along with comparable safety profiles between durvalumab and placebo in PACIFIC, supports the PACIFIC regimen (durvalumab following cCRT) as the new SoC in this setting. However, a proportion of pts are ineligible for cCRT for various reasons, and receive sequential CRT (sCRT) instead. PACIFIC-6 (NCT03693300) will assess the safety, efficacy, and quality of life of durvalumab in NSCLC pts who have not progressed following platinum-based sCRT.

    Method
    

    PACIFIC-6 is a phase II, open-label, multi-centre study to be conducted in 6 countries across Europe and North America. Pts ≥18 years old, with histologically or cytologically documented Stage III, unresectable NSCLC who have not progressed following platinum-based sCRT, and are ECOG PS ≤2 are eligible for inclusion; enrolment is not restricted to a biomarker-defined population. Approximately 150 pts will receive durvalumab (1500 mg intravenously) every 4 weeks for 24 months or until disease progression. Pts will be divided into 2 cohorts according to PS status. Pts will be assessed every 12 weeks, until death, withdrawal of consent, or the end of the study. The primary objective is to assess the safety and tolerability of durvalumab, as defined by grade 3 and 4 treatment-related adverse events (TRAEs) occurring within 6 months from initiation of durvalumab. Secondary objectives include investigator-assessed efficacy measurements such as PFS, overall response rate, duration of response (according to RECIST v1.1), as well as OS, lung-cancer mortality, and further safety assessments of all AEs and serious AEs. Exploratory objectives include assessment of pt-reported symptoms and quality of life, as well as evaluation of the association of tumour-based biomarkers (including PD-L1 expression and tumour mutational burden) with efficacy. Recruitment is ongoing.

    Result
    

    Section not applicable

    Conclusion
    

    Section not applicable

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