Virtual Library

Start Your Search

Marie Huong Nguyen



Author of

  • +

    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
    • +

      185TiP - RATIONALE 001: Tislelizumab (BGB-A317) + concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy in patients (pts) with newly diagnosed locally advanced, unresectable, stage III non-small cell lung cancer (NSCLC) (ID 252)

      12:30 - 13:00  |  Author(s): Marie Huong Nguyen

      • Abstract
      • Slides

      Background

      In pts with locally advanced, unresectable, stage III NSCLC, cCRT is associated with better survival than radiotherapy (RT) alone, but 5-y survival remains poor. Immunotherapies targeting PD-1/PD-L1 may be synergistic with cCRT, improving outcomes. Tislelizumab, an anti–PD-1 antibody, showed clinical activity/tolerability in solid tumors, including NSCLC. RATIONALE 001 is a phase III, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of first-line tislelizumab + cCRT in pts with locally advanced, unresectable, stage III NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Trial design

      RATIONALE 001 aims to answer important scientific questions by employing a 3-arm study design (840 pts randomized 1:1:1) to evaluate whether the timing of giving tislelizumab earlier upfront with cCRT in addition to consolidation will improve outcomes rather than giving the anti–PD-1 as consolidation only (Table). Both tislelizumab approaches (Arms 1 and 2) will each be compared to a global standard of care, cCRT alone. Chemotherapy will be investigator’s choice (cisplatin + etoposide or carboplatin + paclitaxel). RT will be given in 2 Gy fractions (target dose of 60 Gy). Key eligibility: Locally advanced, unresectable, stage III NSCLC; stage III confirmed by FDG-PET and brain imaging; Eastern Cooperative Oncology Group performance status ≤ 1; and no prior anti–PD-1/PD-L1 therapy. PD-L1 expression assessment is not required prior to randomization. Primary endpoint: Progression-free survival. Secondary endpoints include overall survival (OS), OS at 24 mo, objective response rate, and safety. Blood and tumor biomarkers, including PD-L1 expression and tumor mutational burden, will be evaluated for correlations with clinical benefit.

      d9b324a48b043b3d87bc9b3fe620f260 Clinical trial identification

      NCT03745222; EudraCT: 2018-001132-22.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study

      Celgene Corporation.

      213f68309caaa4ccc14d5f99789640ad Funding

      Celgene Corporation.

      682889d0a1d3b50267a69346a750433d Disclosure

      L. Paz-Ares: Honoraria: Lilly, MSD, BMS, Roche, Pharmamar, Merck, AstraZeneca, Novartis, Boehringer Ingelheim, Celgene, Servier, Sysmex, Celgene, Amgen, Incyte, Pfizer; Board member: Genomica; Institutional financial interest: AstraZeneca, BMS, MSD. S. Senan: Grants/Research support: Varian Medical Systems; Advisory/Board member: Celgene, AstraZeneca; Honoraria: Varian Medical Systems, AstraZeneca. D. Planchard: Consulting, honoraria, travel and/or institutional: AZ, BMS, BI, Celgene, Daiichi Sankyo, Eli Lilly, Merck, MedImmune, Novartis, Pfizer, prIME Onc, Peer CME, Roche; Institutional: Medimmune, Sanofi-Aventis, Taiho Pharma, Novocure, Daiichi Sankyo. A. Cheong: Employment, stock holder: Celgene Europe Ltd. R. Slepetis: Employment, stock holder: Celgene. M.H. Nguyen: Employment, stock holder: Celgene Corporation. E.E. Vokes: Employment: University of Chicago; Grants/Research support: AbbVie; Consultant, honoraria: AbbVie, Amgen, AstraZeneca, Biolumina, BMS, Celgene, Eli Lilly, EMD Serono, Genentech, Merck, Novartis, Regeneron. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.