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James Chih-Hsin Yang

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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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      122P - Osimertinib as first-line (1L) treatment for epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC): Final efficacy and safety results from two phase I expansion cohorts (ID 404)

      12:30 - 13:00  |  Presenting Author(s): James Chih-Hsin Yang

      • Abstract
      • Slides


      Osimertinib is a 3rd-generation, CNS-active EGFR-tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR-TKI sensitising (EGFRm) and EGFR T790M resistance mutations. Earlier results from the Ph I AURA (NCT01802632) and Ph III FLAURA (NCT02296125) studies have established 1L osimertinib efficacy. We report final efficacy and safety data from two Ph I expansion cohorts who received 1L osimertinib 80 or 160 mg for advanced EGFRm NSCLC in AURA.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Treatment-naïve pts with locally advanced/metastatic EGFRm NSCLC received osimertinib 80 or 160 mg once daily. Endpoints included objective response rate (ORR), progression-free survival (PFS) and safety evaluation. EGFRm status was confirmed via local and/or central laboratory testing. Key eligibility criteria included measurable disease and WHO performance status 0/1. Pts with stable asymptomatic CNS metastases were eligible. Data cutoff: 1 May 2018.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Overall, 60 patients (pts) were enrolled at two doses (80 mg, n = 30; 160 mg, n = 30): 75% female; 72% Asian; 43% with EGFR ex19del; 48% with L858R. Five pts were EGFR T790M mutation-positive by central test at study entry. Median follow up: 19.1 mo. ORR (95% CI): 67% (47, 83) in the 80 mg cohort, 87% (69, 96) in the 160 mg cohort, 77% (64, 87) overall. Median duration of response (95% CI): 19.3 mo (12.2, 24.7) in the 80 mg cohort, 16.7 mo (9.7, 29.0) in the 160 mg cohort, 18.0 mo (12.5, 24.7) overall. Median PFS (95% CI): 22.1 mo (12.3, 30.2) in the 80 mg cohort, 19.3 mo (11.1, 26.0) in the 160 mg cohort, 20.5 mo (13.7, 26.1) overall (78% maturity). 42% (95% CI 29, 54) and 14% (95% CI 6, 26) of pts were progression free at 24 and 48 mo, respectively. Dose reductions occurred in 27% and 60% of pts at 80 mg and 160 mg, respectively. Most common adverse events overall: (% [Grade ≥3]) diarrhoea (80 mg, 63% [3%]; 160 mg, 87% [7%]), stomatitis (80 mg, 47% [0]; 160 mg, 53% [3%]), paronychia (80 mg, 37% [0]; 160 mg, 57% [10%]).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Consistent with previously reported results, 1L osimertinib for EGFRm advanced NSCLC results in prolonged PFS at both doses and better tolerability at the 80 mg dose.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT01802632 (25 February 2013).

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Editorial acknowledgement

      Medical writing support was provided by Natasha Cary BSc, from iMed Comms, an Ashfield Company and funded by AstraZeneca.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study


      213f68309caaa4ccc14d5f99789640ad Funding


      682889d0a1d3b50267a69346a750433d Disclosure

      J.C-H. Yang: Honoraria: BI, Roche, MSD, AstraZeneca, Novartis; Consulting/advisory: BI, Novartis, AstraZeneca, Roche/Genentech, Clovis Oncology, Lilly, MSD, Merck Serono, Celgene, Astellas Pharma, Bayer, Pfizer, Ono Pharmaceutical, Bristol-Myers Squibb, Yuhan, Hansoh. S.S. Ramalingam: Advisory boards: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Genentech, Lilly, Merck, Roche, Nektar, Loxo, Takeda; Research grants: Merck, Tesaro. C.K. Lee: Advisory boards: AstraZeneca, Roche, Norvatis, Pfizer. Research funding to institution: AstraZeneca for the trials in which I am currently involved. T. Kurata: Research grants: AstraZeneca, MSD; Honoraria: AstraZeneca, MSD, Ono, Bristol-Myers Squibb, Chugai, Eli Lilly. D-W. Kim: Advisory board membership, personal expenses: Novartis. T. John: Consultancy: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Takeda, Pfizer, Novartis, Merck, Roche. N. Nogami: Honoraria: AstraZeneca, Chugai Pharmaceutical, Eli Lilly Japan K.K., MSD, ONO Pharmaceutical, Pfizer Japan Inc., Taiho Pharmaceutical. Y. Ohe: Honoraria, consulting, research funding: AstraZeneca, Chugai, Dainippon Lilly, Ono, BMS Japan, Daiichi Sankyo, BI, Bayer, Ignyta, Pfizer, MSD, Taiho, Novartis, Kyorin, Kyowa Hakko Kirin, Takeda, Celltrion. Y. Rukazenkov: Employee and shareholder: AstraZeneca. P.A. Jänne: Consultancy: AstraZeneca, BI, Pfizer, Merrimack, Roche/Genentech, Chugai, AceaBiosciences, ARIAD Pharma, Ignyta, LOXO Oncology; Stock ownership: Gatekeeper Pharma; Research funding: Astellas, AstraZeneca; IP: EGFR mutations licensed to Lab Corp. All other authors have declared no conflicts of interest.


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