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G. Selvaggi

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    Poster Display session (Friday) (ID 65)

    • Event: ELCC 2018
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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      196TiP - CheckMate 384: A phase 3b/4 dose-frequency optimization trial of nivolumab in advanced or metastatic NSCLC (ID 248)

      12:30 - 13:00  |  Author(s): G. Selvaggi

      • Abstract
      • Slides

      Nivolumab, an anti-programmed death-1 antibody, is approved for previously treated metastatic non-small cell lung cancer (NSCLC) and various other cancers. Based on efficacy and safety results, the approved dosing frequency is every 2 weeks (Q2W) until progression or discontinuation due to toxicity. CheckMate 153 evaluated nivolumab treatment (tx) duration and demonstrated improved outcomes with continuous tx; 1-year progression-free survival (PFS) rates were higher in patients who continued vs stopped tx after 1 year. As an alternative to stopping tx, reducing dosing frequency could optimize convenience during long-term nivolumab therapy while maintaining efficacy and safety; recent exposure-response modeling predicted the benefit–risk profile of nivolumab 480 mg every 4 weeks (Q4W) to be similar to 3 mg/kg Q2W. CheckMate 384, a randomized, open-label phase 3b/4 trial was designed to evaluate less frequent nivolumab dosing (480 mg Q4W vs 240 mg Q2W) in patients with advanced/metastatic NSCLC and prior nivolumab tx.

      Trial design:
      Eligible patients are adults with advanced/metastatic squamous or non-squamous NSCLC and Eastern Cooperative Oncology Group performance status 0–2 who received prior nivolumab 3 mg/kg Q2W or 240 mg Q4W for up to 12 months with a complete or partial response or stable disease confirmed by 2 consecutive assessments. Patients with untreated, symptomatic central nervous system metastases are not eligible. Patients are randomized 1:1 to receive intravenous nivolumab 240 mg Q2W or 480 mg Q4W. Randomization is stratified by histology and response to pre-study nivolumab tx (complete/partial response vs stable disease). Endpoints are shown in the Table. The primary objective is to compare 6-month and 1-year PFS rates between patients who received nivolumab 480 mg Q4W and those who received 240 mg Q2W. Planned enrollment is 620 patients.Table:Study endpoints

      PFS rates at 6 months and 1 year after randomization (co-primary)PFS rate at 1 year after randomization by tumor histology and by response to pre-study nivolumab before randomization
      PFS rate at 2 years after randomization
      Overall survival rate
      Safety and tolerability, as assessed by incidence and severity of adverse events
      Clinical trial identification: NCT02713867; First posted: March 21, 2016

      Clinical trial identification:
      NCT02713867; First posted: March 21, 2016

      Legal entity responsible for the study:
      Bristol-Myers Squibb

      Bristol-Myers Squibb

      E. Garon: Research funding from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Genentech, Merck, Novartis, and Pfizer. N. Reinmuth: Speaker and consulting honoraria and fees from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Hoffmann-La Roche, Lilly, MSD, Novartis, and Pfizer. R. Harris: Consultant for Bristol-Myers Squibb. P. Mitchell: Advisory boards for AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, MSD, Merck Serono, and Roche; Received research funding from Merck Serono. Received honoraria and travel grants from Roche. J. Zhu, G. Selvaggi, S. Agrawal: Employee and shareholder of Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

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