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Pilar Garrido Lopez



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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 2
    • 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): Pilar Garrido Lopez

      • Abstract

      Background

      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

      NCT03798535.

      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.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      180TiP - An open-label, randomized, phase I/II trial of IO102 and pembrolizumab, or IO102, pembrolizumab and chemotherapy, as first-line treatment for patients with metastatic non-small cell lung cancer (ID 208)

      12:30 - 13:00  |  Author(s): Pilar Garrido Lopez

      • Abstract
      • Slides

      Background

      Immunotherapy has significantly changed the treatment landscape of non-small cell lung cancer (NSCLC) with no driver mutations. However, despite the addition of anti-PD-1/PD-L1 therapies to the clinical armamentarium only a subset of patients derives durable benefit. IO102 is a novel, second generation, HLA-A unrestricted immune modulating T-win® vaccine targeting IDO. IO102 has a dual mode of action; remodulation of the tumour micro-environment through elimination of immune suppressive cells and induction of CD8 T-cell mediated killing of IDO-expressing tumor cells. Our first-generation IDO vaccine (IO101) has shown promising antitumor activity and a favorable safety in heavily pretreated NSCLC patients (Iversen, CCR 2013).

      a9ded1e5ce5d75814730bb4caaf49419 Trial design

      Phase I/II, international, multicenter, open-label, randomized trial with two parallel cohorts. Cohort A: IO102 (100µg s.c.) and pembrolizumab (200 mg) (PD-L1 ≥ 50%); Cohort B: IO102, pembrolizumab and carboplatin plus pemetrexed (PD-L1 < 50%). The maximum treatment duration is 35 cycles (app. 2 years). Key eligibility criteria include metastatic NSCLC or non-squamous NSCLC (cohort B) with no prior treatment for metastatic NSCLC and no driver mutations. Phase I is a non-randomized safety run-in with 6 patients per cohort investigating one dose level of the experimental arms. Only one DLT is allowed in each cohort. Phase II is following Sargent’s two-stage, three-outcome optimum design (Sargent, ClinTrial2001) with a 2:1 randomization in the cohorts. Cohort A: IO102 and pembrolizumab versus pembrolizumab alone; Cohort B: IO102, pembrolizumab and chemotherapy vs. pembrolizumab and chemotherapy. Provision of blood and tumour tissue is required for biomarker studies. The primary endpoint is safety and objective response rate (ORR) per RECIST 1.1 in Phases I and II, respectively. Secondary endpoints include ORR per iRECIST, duration of response, progression free survival, overall survival, and biomarkers including immunoscore in tissue, tumour mutational burden and immunomonitoring in blood. The study is enrolling in Europe and US: EudraCT Number 2018-000139-28 / IND Number 018081.

      d9b324a48b043b3d87bc9b3fe620f260 Clinical trial identification

      EudraCT 2018-000139-28 / IND Number: 018081.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study

      IO Biotech.

      213f68309caaa4ccc14d5f99789640ad Funding

      IO Biotech.

      682889d0a1d3b50267a69346a750433d Disclosure

      J. Spicer: Research funding, honoraria (institutional): Achilles, AstraZeneca, Bayer, BerGenBio, Boehringer Ingelheim, BMS, Celgene, Curis; Genmab, Roche, Shionogi, Starpharma, Taiho; Co-founder, shareholder: IGEM Therapeutics. P. Garrido Lopez: Consulting, advisory: I4, MSD, BMS, Boerhinger Ingelheim, Pfizer, AbbVie, Guardant Health, Novartis, Lilly, AstraZeneca, Janssen, Sysmex, Blueprint Medicines, Takeda; Speaker: Roche, MSD, BMS, Pfizer, Novartis, Boerhinger Ingelheim. J. Bosch-Barrera: Advisory board: MSD. E. Felip: Advisory: Blue Print Medicines, Celgene, Guardant Health, Janssen; Advisory, speaker: AbbVie, AstraZeneca, Boehringer Ingelheim, BMS, Eli Lilly, Merck KGaA, MSD, Novartis, Pfizer, Roche, Takeda; Consultant: Boehringer Ingelheim. J. Trigo: Advisory board: Takeda, BMS, Boehringer; Speaker: BMS, Boehringer, Roche, AstraZeneca. S. Viteri: Speaker fees: BMS, Roche; Travel fees: Servier, Roche, Merck Serono; Advisory fees: Roche, AbbVie; Research fees: Roche, BMS, Servier, Merck Serono, AbbVie, Janssen. E. Schmidt: Employed: Merck & Co., Inc. A.V. Christiansen, E. Ehrnrooth: Employed: IO Biotech; Member of the Safety Monitoring Committee for the IO102-012/KN-764 trial. M-B. Zocca: Chief Executive Officer, founder: IO Biotech; Member of the Safety Monitoring Committee for the IO102-012/KN-764 trial. M.H. Andersen: Chief Scientific Officer, founder, member of BoD: IO Biotech. L. Paz-Ares: Advisory board: Roche, Lily, MSD, BMS, Boehringer Ingelheim, Novartis, AstraZeneca, Amgen, Pfizer. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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    Opening and welcome (ID 4)

    • Event: ELCC 2019
    • Type: Opening and welcome
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/10/2019, 13:30 - 13:45, Room B
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      Welcome to the Congress (ID 734)

      13:30 - 13:45  |  Presenting Author(s): Pilar Garrido Lopez

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    Optimising treatment in stage III (ID 10)

    • Event: ELCC 2019
    • Type: Educational session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/10/2019, 16:30 - 18:00, Room A
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      Is there only one standard of care in stage III NSCLC? (ID 25)

      16:30 - 18:00  |  Presenting Author(s): Pilar Garrido Lopez

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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