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Poster Display

1162 - Randomized phase 2 trial of gefitinib with and without pemetrexed as first-line therapy in East Asian patients with advanced, epidermal growth factor receptor (EGFR) mutation-positive (mt+), nonsquamous (NS) non-small cell lung cancer (NSCLC): Translational research and interim overall survival (OS)


08 Oct 2016


Poster Display


James Yang


Annals of Oncology (2016) 27 (6): 416-454. 10.1093/annonc/mdw383


J. Yang1, Y. Cheng2, H. Murakami3, P. Yang4, J. He5, K. Nakagawa6, J.H. Kang7, J. Kim8, R. Hozak9, T. Nguyen10, X. Wang11, S. Enatsu12, T. Puri13, M. Orlando14

Author affiliations

  • 1 Department Of Oncology, National Taiwan University Hospital, 100 - Taipei/TW
  • 2 Department Of Medical Oncology, Jilin Province Cancer Hospital, 130012 - Changchun/CN
  • 3 Department Of Oncology, Shizuoka Cancer Center, Shizuoka/JP
  • 4 Department Of Oncology, National Taiwan University Hospital, Taipei/TW
  • 5 Department Of Thoracic Oncology, The 1st Affiliated Hospital of Guangzhou Medical University, 510120 - Guangzhou/CN
  • 6 Department Of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama/JP
  • 7 Department Of Medical Oncology, The Catholic University of Korea, 137-701 - Seoel/KR
  • 8 Department Of Oncology, CHA Bundang Medical Center, CHA University, Gyeonggi-do/KP
  • 9 Oncology Business Unit, Eli Lilly and Company, Indianapolis/US
  • 10 Oncology Tailoring Biomarker Statistics, Eli Lilly and Company, Indianapolis/US
  • 11 Medicines Development Unit, Eli Lilly and Company, Shanghai/CN
  • 12 Medicines Development Unit, Eli Lilly Japan K.K., Kobe/JP
  • 13 Medical Affairs, Eli Lilly and Company, Gurgaon/IN
  • 14 Emerging Markets Medical Affairs, Eli Lilly and Company, Buenos Aire/AR


Abstract 1162


The primary analysis of this open-label, randomized, multicenter, phase 2 study found significantly longer progression-free survival (PFS) for pemetrexed plus gefitinib (P + G) vs gefitinib alone (G) in 191 East Asian patients with EGFR mt+ NS NSCLC (adjusted hazard ratio [HR]: 0.68; 95% confidence interval [CI]: 0.48-0.96; P = 0.029). Translational research, interim OS data and updated safety results are reported.


Treatment-naive patients with advanced, EGFR mt+ (local laboratory testing), NS NSCLC were randomized (2:1) to receive P + G (pemetrexed 500 mg/m2, Day 1 of 21-day cycles plus gefitinib 250 mg/day; n = 126) or G (gefitinib 250 mg/day; n = 65). Mandatory pretreatment tissue samples were assayed for EGFR mutations by central evaluation (CE) (n = 159) and thymidylate synthase (TS) by immunohistochemistry (n = 146). OS in the intention-to treat (ITT) population and correlation of biomarkers with clinical outcomes were analyzed by adjusted Cox regression.


By CE, 149/159 patients (93.7%) were EGFR mt+. In the CE+ population, PFS was longer for P + G (n = 96) vs G (n = 53) (HR: 0.72; 95% CI: 0.48-1.06; P = 0.093), consistent with the primary analysis based on local testing. In patients with low (n = 67) and high (n = 79) TS expression, the PFS HR was 0.47 (95% CI: 0.26-0.87) and 0.83 (95% CI: 0.47-1.46), respectively; the interaction effect was not statistically significant (P = 0.177). At the interim OS analysis (80 events, 58% censoring), OS was not significantly different for P + G vs G (HR: 0.79; 95% CI: 0.49-1.28; P = 0.342). Postdiscontinuation systemic therapy was common (P + G: 62.7%; G: 72.3%). The incidence of grade 3/4 drug-related adverse events was significantly (P = 0.002) higher for P + G (42.9%) vs G (20.0%).


The PFS HR for the CE+ population was consistent with the primary ITT analysis. No significant interaction effects were seen for TS. At this interim analysis, there was no statistical difference in OS for P + G vs G. Final OS analyses will be reported when 130 events have occurred.

Clinical trial identification


Legal entity responsible for the study

Eli Lilly and Company


Eli Lilly and Company


J. Yang: Astrazeneca, Roche, Eli Lilly, Boehringer Ingelheim, Pfizer, Clovis Oncology, Novartis, Bayer, MSD, Merck, Astellas, Daichi-Sankyo, Celgene. H. Murakami: Research funding from Eli Lilly, Kyowa Kirin, Chu-gai, AstraZeneca, Novartis., Astellas, Taiho, Quintiles Transnational, Clovis Oncology. Honoraria from Boehringer-ingelheim, Pfizer, Chu-gai, Taiho, Nippon Kayaku, Clovis Oncology. K. Nakagawa: Honoraria received from Eli Lilly Japan K.K., Daiichi Sankyo Co., Ltd. Speakers Bureau from Eli Lilly Japan K.K. /Daiichi Sankyo Co., Ltd. Grants/Research Support received from Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd. J.H. Kang: Advisory Board member for Eli Lilly and Company. J-H. Kim: Consulted/advised for Eli Lilly and Company. R. Hozak, T. Nguyen, X. Wang, T. Puri, M. Orlando, S. Enatsu: Employee and shareholder of Eli Lilly and Company. All other authors have declared no conflicts of interest.

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