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Gilberto Lopes



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    ESMO-IASLC Best Abstracts (ID 62)

    • Event: ELCC 2019
    • Type: Proffered Paper session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 14:45 - 16:15, Room B
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      103O_PR - Safety and efficacy of pembrolizumab (Pembro) monotherapy in elderly patients (Pts) with PD-L1–positive advanced NSCLC: Pooled analysis from KEYNOTE-010, -024, and -042 (ID 466)

      14:45 - 16:15  |  Author(s): Gilberto Lopes

      • Abstract
      • Presentation
      • Slides

      Background

      Approximately 70% of newly-diagnosed NSCLC cases occur in the elderly, and more than half are locally advanced/metastatic. We present a pooled analysis of efficacy and safety in elderly pts (aged ≥75 y) enrolled in 3 randomized controlled trials of pembro monotherapy vs standard chemotherapy (chemo) for PD-L1–positive advanced NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Pts were aged ≥18 y with advanced NSCLC with PD-L1 tumor proportion score (TPS) ≥1% (KEYNOTE-010, -042) or TPS ≥50% (KEYNOTE-024). In KEYNOTE-010, pts were randomized to pembro 2 or 10 mg/kg Q3W or docetaxel, as second- or later-line therapy. In KEYNOTE-024 and -042, pts were randomized to first-line pembro 200 mg Q3W or platinum-based chemo. OS was estimated by the Kaplan-Meier method.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      The 3 trials included 264 pts aged ≥75 (range, 75–90) y with TPS ≥1%; 132 pts had TPS ≥50%. Independent of line of treatment, HRs (95% CI) for OS favored pembro vs chemo: 0.76 (0.56–1.02) in pts with TPS ≥1% and 0.40 (0.25–0.64) in pts with TPS ≥50%. Pembro also improved OS vs chemo in the pooled analysis of pts with TPS ≥50% who received first-line therapy (KEYNOTE-024 and -042): HR, 0.41 (95% CI, 0.23–0.73). Overall, fewer treatment-related AEs across various categories were observed with pembro vs chemo, in particular, grade 3–5 treatment-related AEs in pts aged ≥75 y (Table). Immune-mediated AEs and infusion reactions were more frequent with pembro vs chemo, with similar frequency in pts receiving pembro aged ≥75 y and <75 y (Table).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      In this pooled analysis of pts aged ≥75 y with PD-L1–positive advanced NSCLC, pembro monotherapy improved OS vs chemo, both in pts with PD-L1 TPS ≥1% and PD-L1 TPS ≥50%. The safety profile of pembro was similar in pts aged ≥75 y and <75 y, with lower rates of grade 3–5 treatment-related AEs vs chemo.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT01905657 (KEYNOTE-010); NCT02142738 (KEYNOTE-024); NCT02220894 (KEYNOTE-042).

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical writing and editorial assistance was provided by Michael S. McNamara, MS, of C4 MedSolutions, LLC (Yardley, PA), a CHC Group company and funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

      213f68309caaa4ccc14d5f99789640ad Funding

      Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

      682889d0a1d3b50267a69346a750433d Disclosure

      K. Nosaki: Honoraria: AstraZeneca, Chugai Pharmaceutical, Eli Lilly, MSD; Institutional research funding: MSD. Y. Hosomi: Personal fees: MSD, AstraZeneca, Eli Lilly Japan, Taiho Pharmaceutical, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol-Myers Squibb. H. Saka: Grants/research support: AstraZeneca, MSD, Ono Pharmaceutical; Honoraria: AstraZeneca, MSD, Ono Pharmaceutical, Chugai Pharmaceutical, Boehringer Ingelheim, Kyorin Pharmaceutical. P. Baas: Consulting role: Genentech/Roche, Merck, Bristol-Myers Squibb, Pfizer; Research support: Bristol-Myers Squibb, Roche, Merck. G. de Castro Jr: Consulting/advisory role: AstraZeneca, MSD, BMS, Roche, Novartis, Boehringer Ingelheim; Speakers’ bureau: MSD, BMS, Novartis, AstraZeneca; Travel/accommodation expenses: MSD, BMS, Roche, Bayer, Novartis, Boehringer Ingelheim, AstraZeneca. M. Reck: Personal fees: Amgen, Hoffmann-La Roche, Lilly, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, MSD, Merck, Novartis, Pfizer, AbbVie. Y-L. Wu: Honoraria: AstraZeneca, Eli Lilly, Roche, Pierre Fabre, Pfizer, Sanofi; Consulting/advisory role: AstraZeneca, Roche, Merck, Boehringer Ingelheim; Research funding to institution: Boehringer Ingelheim, Roche. J.R. Brahmer: Grant, personal fees, Advisory boards, consulting: Merck; Uncompensated advisor and consultant: Bristol-Myers Squibb; Grants: Bristol-Myers Squibb, MedImmune/AstraZeneca; Personal fees: Amgen, Celgene, Lilly. E. Felip: Consulting, advisory role, speaker’s bureau: AbbVie, AstraZeneca, Blueprint Medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Guardant Health, Janssen, Merck KGaA, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda; Research funding: Fundación Merck Salud; Grant for Oncology Innovation EMD Serono. T. Sawada, K. Noguchi, S.R. Han: Employee: MSD K.K., Tokyo, Japan. B. Piperdi, D.A. Kush: Employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. G. Lopes: Research funding to institution: Merck & Co., Inc., EMD Serono, AstraZeneca.

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