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Hideo Saka



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    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
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      151P - Safety and tolerability of pembrolizumab or placebo plus pemetrexed and platinum as first-line therapy in Japanese patients (PTS) with metastatic non-squamous non-small cell lung cancer (NSCLC) enrolled in the phase III KEYNOTE-189 study (ID 484)

      12:30 - 13:00  |  Author(s): Hideo Saka

      • Abstract
      • Slides

      Background

      The global, randomized, double-blind, phase 3 KEYNOTE-189 study (NCT02578680) showed significantly improved OS and PFS with pembrolizumab (pembro) + pemetrexed (pem) + platinum compared with placebo + pem + platinum with a manageable safety profile in pts with previously untreated metastatic nonsquamous NSCLC without targetable EGFR/ALK aberrations|. We present safety and tolerability data from Japanese pts enrolled in KEYNOTE-189.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Eligible pts enrolled in Japan during the global or extension study of KEYNOTE-189 were randomized 2:1 to pembro 200 mg Q3W or placebo for up to 35 cycles (∼2 y); all pts received pem 500 mg/m2 (until progressive disease or intolerable toxicity) and 4 cycles of carboplatin AUC 5 or cisplatin AUC 75 mg/m2. Safety and tolerability were assessed by clinical review of all relevant parameters; adverse events (AEs) and laboratory abnormalities were graded per NCI CTCAE v4.0.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Of 40 pts enrolled in Japan (global study, n = 10; extension study, n = 30), 25 were randomized to the pembro arm, and 15 to the placebo arm. There were no meaningful differences in baseline characteristics, apart from a smaller proportion of pts with brain metastases (16% vs 33%), and larger proportion with PD-L1 TPS <1% (56% vs 40%) and cisplatin recipients (72% vs 53%) in the pembro vs placebo arm, respectively. The median (range) follow-up was 5.6 (2.4–12.9) mo and 7.0 (2.4–19.8) mo in the pembro and placebo arms, respectively. There were no deaths due to AEs. Grade 3/4 AEs occurred in 13 pts (52%) in the pembro arm and 8 (53%) in the placebo arm. 6 (24%) vs 3 pts (20%) had immune-mediated AEs and infusion reactions, with no events of pneumonitis reported in the pembro arm vs 2 (13.3%) in the placebo arm. Overall, AEs led to treatment discontinuation in 4 (16%) pts in the pembro vs 3 (20%) pts in the placebo arm.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Pembro + pem + platinum demonstrated a tolerable and manageable safety profile in Japanese pts, generally consistent with the overall pt population in the global KEYNOTE-189 study. No new safety concerns were identified in Japanese pts.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT02578680.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical writing assistance was provided by Shilpa Aggarwal, PhD, of C4 MedSolutions, LLC (Yardley, PA, USA), a CHC Group company and was funded by 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

      H. Horinouchi: Corporate-sponsored research: MSD, Eli Lilly, BMS. N. Nogami: Honoraria: Pfizer Inc., Chugai Pharmaceutical Co. Ltd, Eli Lilly, Taiho Pharmaceutical Co. Ltd., AstraZeneca, Kyowa Hakko Kirin, Ono Pharmaceutical Co. Ltd., MSD. H. Saka: Grants/research support: AstraZeneca, MSD, Ono Pharmaceutical; Honoraria: AstraZeneca, MSD, Ono Pharmaceutical, Chugai Pharmaceutical, Boehringer Ingelheim, Kyorin Pharmaceutical. M. Nishio: Grants and personal fees: Ono Pharmaceutical, Bristol-Myers Squibb, Pfizer, Chugai Pharmaceutical, Eli Lilly, Taiho Pharmaceutical, AstraZeneca, Boehringer-Ingelheim, MSD, Novartis; Personal fees: Daiichi Sankyo Healthcare, Merck Serono; Grants: Astellas, outside the submitted work. T. Tokito: Honoraria: AstraZeneca, MSD, Ono, Chugai. T. Takahashi: Grants, personal fees: Ono Pharmaceutical Co., Ltd., MSD K.K., AstraZeneca KK, Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K.; Grants: Pfizer Japan Inc.; Personal fees: Boehringer Ingelheim Japan, Inc, Roche Diagnostics K.K. K. Kasahara: Grants, honoraria: Boehringer Ingelheim; Honoraria: Pfizer, Chugai Pharmaceutical, Eli Lilly, Taiho Pharmaceuticals, AstraZeneca, MSD. Y. Hattori: Research funding: MSD, Ono; Honoraria: AstraZeneca, Boehringer Ingelheim, Chugai, Eli Lilly, MSD, Novartis, Ono, Taiho. E. Ichihara: Research grants: Eli Lilly, MSD. N. Adachi, T. Sawada, T. Shimamoto, K. Noguchi: Employee: MSD K.K., Tokyo, Japan. M.C. Pietanza: Employee: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. T. Kurata: Research grants: AstraZeneca, MSD; Honoraria: AstraZeneca, MSD, Ono, Bristol-Myers Squibb, Chugai, Eli Lilly.

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