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Kateyln Dipiazza



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    P2.01 - Advanced NSCLC (ID 159)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.01-18 - ORION: A Phase 2, Randomised, Multicentre, Double-Blind Study to Assess Efficacy and Safety of Durvalumab+Olaparib Versus Durvalumab Alone as Maintenance Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC) (Now Available) (ID 636)

      10:15 - 18:15  |  Author(s): Kateyln Dipiazza

      • Abstract
      • Slides

      Background

      Systemic chemotherapy for first-line (1L) metastatic NSCLC shows mixed outcomes. Results from studies using immunotherapy alone or combined with chemotherapy as 1L treatment in patients (pts) with metastatic NSCLC represent a substantial advance, but further improvement is needed. Increased deoxyribonucleic acid damage triggered by polyadenosine 5’diphosphoribose polymerase inhibition may confer antitumour activity, modify tumour immunogenicity and further sensitise tumours to immune checkpoint inhibition, thus promoting a more durable antitumour response. This Phase 2, randomised, multicentre, double-blind study (NCT03775486) is designed to assess the efficacy and safety of durvalumab+olaparib versus durvalumab alone as maintenance therapy in pts whose stage IV NSCLC has not progressed following 1L platinum-based chemotherapy+durvalumab.

      Method

      Adult pts with stage IV NSCLC with tumours lacking activating EGFR mutations and ALK fusions are eligible. In the initial therapy phase, all pts will receive durvalumab (1500 mg intravenously [IV]) concurrent with platinum-based doublet therapy. Durvalumab+chemotherapy will be administered for 4 cycles for both squamous NSCLC (nanoparticle albumin-bound [nab]-paclitaxel+carboplatin or gemcitabine+carboplatin/cisplatin) and nonsquamous NSCLC (nab-paclitaxel+carboplatin or pemetrexed+carboplatin/cisplatin). Pts whose disease does not progress (complete or partial response [CR/PR] or stable disease [SD]; investigator-assessed RECIST 1.1) will be randomised (1:1) to durvalumab (1500 mg IV, every 4 weeks) + either olaparib (300 mg, oral, twice daily) or its matching placebo until disease progression. Randomisation will be stratified based on objective response to durvalumab+chemotherapy (CR/PR or SD) during the initial therapy phase and histology (squamous or nonsquamous).

      Result

      The primary endpoint is progression-free survival (PFS) (investigator-assessed, RECIST 1.1). Secondary endpoints are overall survival, PFS in pts with homologous recombination repair-related gene mutation, objective response rate, duration of response, health-related quality of life, pharmacokinetics and immunogenicity of durvalumab, as well as safety.

      Conclusion

      The study start date was 21 December 2018 and patient enrolment is ongoing. All patients will be followed for survival until the end of the study. The estimated primary completion date is 5 October 2020 and the estimated study completion date is 2 June 2022.

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