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Sandrine Niyongere



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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
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.01-06 - Phase I Study of Nivolumab and Ipilimumab Combined with Nintedanib in Advanced Non-Small Cell Lung Cancer (ID 2000)

      10:15 - 18:15  |  Author(s): Sandrine Niyongere

      • Abstract
      • Slides

      Background

      Cancer-associated fibroblasts (CAFs) in the tumor microenvironment (TME) inhibit tumor infiltrating lymphocyte activation and are potentially immunosuppressive. Targeting the TME may represent an important synergistic approach in immunotherapy (IO). Combination IO with nivolumab and ipilimumab has proven clinical activity in NSCLC. Nintedanib is an orally available triple kinase inhibitor that is active against NSCLC, inhibits CAFs, and targets VEGFR, FGFR and PDGFR. We report the preliminary results of a phase 1 dose escalation trial evaluating the combination of nintedanib with nivolumab and ipilimumab (N+N+I) in advanced NSCLC pts.

      Method

      This is single center, investigational, non-randomized trial of IO naïve or IO pretreated pts with locally advanced or metastatic NSCLC. Primary endpoint is to determine the safety and tolerability of concurrent administration of the proposed regimen. Key secondary endpoints include RR, DOR, OS, PFS. Five dose levels of nintedanib (dose level -1, 0, 1, 2 and 3 with nintedanib given at dose 100 mg once daily,150 mg once daily and 100mg, 150 mg and 200 mg twice daily respectively) are given with fixed dose of nivolumab (3mg/kg every 2 weeks) and ipilimumab (1mg/kg every 6 weeks). Dose escalation was achieved by the 3+3 design. Blood and tumor biopsies are obtained to evaluate potential predictive and resistance mechanisms.

      Result

      Enrollment to phase I dose escalation was started on 29th January 2018 and to date 13 patients have been treated on dose level -1 (3), 0 (5) and 1(5). 54% (7) were IO pretreated and 46% (6) were IO naive. Median age is 65 with 62% (8) female patients, ECOG 1 62% (8) and 15% (2) never smoker/ 85% (11) prior or current smokers. Most common AE of any grade were transaminitis and rash in 23% (3). Most G3 AE was transaminitis 8% (1). There were no G4/5 AEs or DLTs. There was no treatment discontinuation due to AEs. PD-L1 expression was < or = 1% in 46% (6), 1-49% in 8% (1) and >/= 50% in 46% (6) pts. Amongst the 12 patients evaluable for confirmed response, 17% (2) had PR, 50% (6) had SD and 33% (4) had PD. In the IO pretreated group, 14% (1) had PR, 57% (4) had SD and 28% (2) had PD.

      Conclusion

      The combination of N+N+I was well tolerated. The regimen demonstrates antitumor activity despite progression on prior IO. The updated and mature data of the phase I dose escalation trial will be presented at the meeting. Clinical trial information: NCT03377023.

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