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S. Kim



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    Poster Display Session (ID 63)

    • Event: ELCC 2017
    • Type: Poster Display Session
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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      114P - Phase II study of nivolumab in patients with advanced non-small cell lung cancer (NSCLC) in Korea (ID 441)

      12:30 - 13:00  |  Author(s): S. Kim

      • Abstract

      Background:
      Nivolumab (BMS-936558/ONO-4538), a fully human IgG4, PD-1 immune-checkpoint inhibitor antibody, has shown durable clinical activity in several tumor types. Recently, two phase III studies (CheckMate-017 and -057) demonstrated that nivolumab improved overall survival (OS) than docetaxel in second-line of squamous (SQ) and non-squamous (NSQ) Non-Small Cell Lung Cancer (NSCLC), respectively. Here, we report the results of a phase II study to evaluate the efficacy and safety of nivolumab in Korean patients (pts) with previously treated advanced SQ and NSQ NSCLC.

      Methods:
      This study requires pts aged ≥ 20 years with ECOG Performance Status (PS) of 0 or 1, stage IIIB/IV or recurrent NSCLC and at least one prior chemotherapy including platinum containing regimen. Pts received nivolumab 3 mg/kg IV Q2W until progression or unacceptable toxicity. The primary endpoint in this study was the objective response rate (ORR) (RECIST v1.1).

      Results:
      Nivolumab was administered to 100 NSCLC pts (SQ: 44, NSQ: 56), male/female: 78 (SQ: 44, NSQ: 34)/22 (SQ: 0, NSQ: 22); PS 0/1: 14 (SQ: 6, NSQ: 8)/86 (SQ: 38, NSQ: 48); aged 29 to 80 [median: 66.5] years (SQ: 40 to 80 [median: 69.5], NSQ: 29 to 77 [median: 63.5]); Stage IIIB/IV/recurrence: 6 (SQ: 5, NSQ: 1)/91 (SQ: 37, NSQ: 54)/3 (SQ: 2, NSQ: 1)). In SQ and NSQ NSCLC, ORR was 15.9% (7/44) and 23.2% (13/56), respectively. Median progression-free survival was 2.6 mo and 5.3 mo, respectively. Complete Response was observed in 2.3% (1/44) and 1.8% (1/56), respectively. Median OS was 12.3 mo and 16.3 mo, respectively. Median follow-up was 8.9 mo and 12.3 mo, respectively. Most common adverse drug reaction (ADR) was decreased appetite 15.9% (7/44), followed by pyrexia 9.1% (4/44) in SQ NSCLC, and decreased appetite 12.5% (7/56), followed by pruritus 10.7% (6/56), fatigue 8.9% (5/56), pyrexia 5.4% (3/56) and nausea 5.4% (3/56) in NSQ NSCLC. Grade 3-4 ADR was observed in 6.8% (3/44) and 10.7% (6/56) of SQ and NSQ NSCLC, respectively. No interstitial lung disease and no grade 5 ADRs were observed in this study.

      Conclusions:
      Nivolumab was considered to be effective and used safely in Korean pts with SQ and NSQ NSCLC as well as in non-Korean pts with SQ and NSQ NSCLC.

      Clinical trial identification:
      NCT02175017

      Legal entity responsible for the study:
      Ministry of Food and Drug Safety in Korea

      Funding:
      Ono Pharmaceutical

      Disclosure:
      J.H. Kang: Honoraria; Bristol-Myers Squibb, Boehringer Ingelheim Consulting or Advisory Role; Bristol-Myers Squibb, Amgen Research Funding; AstraZeneca, Lilly. K. Park: Consulting or Advisory Role; Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Clovis Oncology, Lilly, Hanmi, Kyowa Hakko Kirin, Novartis, Ono Pharmaceutical, Roche, Speakers\' Bureau; Boehringer Ingelheim Research Funding: AstraZeneca. All other authors have declared no conflicts of interest.

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      141TiP - ASTRIS: A multicenter, real world treatment study of osimertinib in EGFR T790M positive non-small cell lung cancer (NSCLC) (ID 278)

      12:30 - 13:00  |  Author(s): S. Kim

      • Abstract

      Background:
      EGFR tyrosine kinase inhibitors (TKIs) are the first-line treatment for patients with EGFR mutation positive advanced NSCLC. Resistance develops due to a secondary EGFR T790M mutation in approximately 60% of cases. Osimertinib is an oral, irreversible, central-nervous system (CNS) active, EGFR-TKI selective for both EGFR-TKI sensitising and T790M resistance mutations. In a Phase III trial versus platinum-based doublet chemotherapy in patients with T790M positive NSCLC (AURA3), osimertinib provided a significantly longer progression-free survival (PFS; median 10.1 mths vs. 4.4 mths; hazard ratio 0.30; 95% CI 0.23, 0.41; p < 0.001) and higher response rates (71% vs 31%; odds ratio 5.39; p < 0.001) (Mok et al, New Engl J Med 2016). Currently, there is limited evidence of the efficacy of osimertinib outside of clinical trials.

      Trial design:
      ASTRIS is a Phase III open-label, single-arm, multi-national, real world treatment study assessing the efficacy and safety of osimertinib in patients with advanced T790M mutation positive NSCLC, who have previously received an EGFR-TKI. Approximately 3500 patients will be enrolled across Asia, Europe and North and South America on a rolling basis. Country level enrolment is to stop within 6 months of market licence approval or national reimbursement. Key inclusion criteria are adults with locally advanced or metastatic NSCLC having a confirmed T790M mutation who received a prior EGFR-TKI and have World Health Organization performance status 0 − 2. T790M status must be confirmed by an appropriately validated test. Patients with asymptomatic CNS metastases, not requiring an increasing corticosteroid dose within 2 weeks prior to osimertinib administration, are allowed. Osimertinib 80 mg will be administered orally once daily for as long as the patient continues to receive clinical benefit, as judged by the investigator. The primary efficacy outcome is overall survival: secondary outcomes include investigator assessed response rate, PFS, and time to treatment discontinuation. Baseline demographics and disease characteristics, T790M mutation testing results and safety will also be reported.

      Clinical trial identification:
      NCT02474355 (27 May 2015)

      Legal entity responsible for the study:
      AstraZeneca

      Funding:
      AstraZeneca

      Disclosure:
      P.K. Cheema: Advisory board: Astrazeneca, Bristol Myers Squibb, Novartis, Boehringer Ingelheim, Pfizer, Merck Research sponsors: Astrazeneca, Hoffmann La Roche, Boehringer Ingelheim. Y-M. Chen: Advisory board of AstraZeneca, Boehringer Ingelheim, Roche and Merck Sharp & Dohme. H.C. Freitas: Member of ASTRIS steering committee, a research program supported by Astra Zeneca. A. Milner: Employee of AstraZeneca, who sponsored the study. M. Provencio: Honoraria for consultancy work from MSD, Bristol-Myers Squibb, Roche and Astrazeneca. J. Rigas: Consultant, through Kelly Service, for AstraZeneca in Global Medical Affairs on osimertinib (TAGRISSO). Y-L. Wu: Speaker fees from AstraZeneca, Roche, Eli Lilly. All other authors have declared no conflicts of interest.