114P - Phase II study of nivolumab in patients with advanced non-small cell lung cancer (NSCLC) in Korea

Date 07 May 2017
Event ELCC 2017
Session Poster Display Session
Topics Immunotherapy
Thoracic Malignancies
Non-Small Cell Lung Cancer
Presenter Eun Kyung Cho
Citation Annals of Oncology (2017) 28 (suppl_2): ii28-ii51. 10.1093/annonc/mdx091
Authors E.K. Cho1, J.H. Kang2, J. Han3, J.S. Lee4, D. Kim5, S. Kim6, Y.J. Min7, K.H. Lee8, J. Kim9, K. Park10
  • 1Department Of Internal Medicine, Gachon University Gil Hospital, 21565 - Incheon/KR
  • 2Seoul St. Mary's Hospital, of the Catholic University, Seoul/KR
  • 3National Cancer Center, Goyang/KR
  • 4Seoul National University Bundang Hospital, Seongnam/KR
  • 5Seoul National University Hospital, Seoul/KR
  • 6Asan Medical Center, Seoul/KR
  • 7Ulsan University Hospital, Ulsan/KR
  • 8Chungbuk National University Hospital, Cheong-ju/KR
  • 9Bundang Cha Hospital, Seongnam/KR
  • 10Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul/KR



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.


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).


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.


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


Legal entity responsible for the study

Ministry of Food and Drug Safety in Korea


Ono Pharmaceutical


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.