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Ranier Fietkau

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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      101TiP - PACIFIC-R: First real-world study of patients with unresectable, stage III NSCLC treated with durvalumab after chemoradiotherapy (ID 236)

      12:30 - 13:00  |  Author(s): Ranier Fietkau

      • Abstract


      Approximately 30% of patients (pts) with non-small-cell lung cancer (NSCLC) are diagnosed with Stage III disease, which is often unresectable. Historically, the standard of care (SoC) has been platinum-based chemoradiotherapy (CRT), but outcomes have been poor. Durvalumab is a selective high-affinity, human IgG1 monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80. In the phase 3 PACIFIC trial of durvalumab versus placebo in pts with unresectable, Stage III NSCLC without progression after concurrent CRT (cCRT), both primary endpoints progression-free survival (PFS) and overall survival (OS) were met and significantly improved 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) with similar safety between treatments (Antonia et al, NEJM 2017; 2018). Based on these findings, the PACIFIC regimen (durvalumab following CRT) is becoming the SoC. PACIFIC-Real World (PACIFIC-R) will assess if durvalumab treatment after cCRT shows similar efficacy and safety in a large, real-world population.

      a9ded1e5ce5d75814730bb4caaf49419 Trial design

      PACIFIC-R is an international, observational study that will enroll ∼1200 NSCLC pts who have received durvalumab as part of early access programs (EAPs) between Sept 2017 and Dec 2018. In the EAP, eligible pts are adults with histologically or cytologically documented unresectable, Stage III NSCLC, regardless of tumor PD-L1 expression, who have not progressed after definitive CRT. Pts received durvalumab (10 mg/kg intravenously) every two weeks. Pts will be enrolled in the PACIFIC-R study after discontinuation of the EAP in participating countries. Data will be abstracted from pts’ medical records at several time points within the 5 year study period. Primary endpoints are PFS (investigator assessed) and OS. Secondary endpoints include PFS and OS in pt subgroups; time to distant metastases; sites of disease progression; adverse events of special interest leading to treatment interruption, discontinuation or medical intervention; and descriptive analyses of demographic and clinical characteristics of pts treated with durvalumab in a real-world setting. Recruitment for this study is ongoing.

      d9b324a48b043b3d87bc9b3fe620f260 Clinical trial identification


      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical writing support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by James King of Cirrus Communications (Macclesfield, UK), an Ashfield company, and was funded by AstraZeneca.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      AstraZeneca AB.

      213f68309caaa4ccc14d5f99789640ad Funding

      AstraZeneca AB.

      682889d0a1d3b50267a69346a750433d Disclosure

      N. Girard: Personal fees: AstraZeneca, MSD, BMS, Roche, during the conduct of the study. F. Mornex, D.C. Christoph, R. Fietkau, J. Field, P. Garrido Lopez: Conflict of Interests not immediately avaliable, will be following up with congress directly to provide as soon as possible. A.R. Filippi: Personal fees: AstraZeneca during the conduct of the study. McDonald: Personal fees: AstraZeneca, Elekta; Research grants: MSD, outside the conduct of the study. S. Peters: Personal fees: AbbVie, Amgen, AZ, Bayer, Biocartis, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F Hoffman-LaRoche, Foundation Medicine, Illumina, Janssen, Merck, Merrimack, Novartis, PharmaMar, Pfizer, Regeneron, Sanofi. A.B. Klein, M. Licour: Employment, stock: AstraZeneca outside the conduct of the study. M.C. Garassino: Personal fees: MSD, BMS, AstraZeneca, Roche, outside the conduct of the study.