A Randomized Phase 2 Study Comparing the Combination of Ficlatuzumab and Gefitinib with Gefitinib Alone in Asian Patients with Advanced Stage Pulmonary.

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A Randomized Phase 2 Study Comparing the Combination of Ficlatuzumab and Gefitinib with Gefitinib Alone in Asian Patients with Advanced Stage Pulmonary Adenocarcinoma Tony Shu Kam Mok, MD, Sarayut Lucien Geater, MD, Wu-Chou Su, MD, Eng-Huat Tan, M.B.B.S., James Chi-Hsin Yang, MD, PhD, Gee-Chen Chang, MD, May Han, PhD, Philip Komarnitsky, MD, PhD, MBA, Francis Payumo, ScM, Jennifer E. Garrus, PhD, Sandra Close, PhD, Keunchil Park, MD, PhD Journal of Thoracic Oncology Volume 11, Issue 10, Pages 1736-1744 (October 2016) DOI: 10.1016/j.jtho.2016.05.038 Copyright © 2016 International Association for the Study of Lung Cancer Terms and Conditions

Figure 1 P06162 Trial profile. RECIST, Response Evaluation Criteria in Solid Tumors; ECOG PS, Eastern Cooperative Oncology Group Performance Status; G, gefitinib; F, ficlatuzumab. Journal of Thoracic Oncology 2016 11, 1736-1744DOI: (10.1016/j.jtho.2016.05.038) Copyright © 2016 International Association for the Study of Lung Cancer Terms and Conditions

Figure 2 Kaplan–Meier curves by treatment arm for (A) progression-free survival (PFS) in the intent-to-treat (ITT) population, (B) overall survival (OS) in the ITT population, (C) PFS in the ITT population of the subgroup with an EGFR TKI–sensitizing mutation (EGFRsm+) subgroup, and (D) OS in the ITT population of the EGFRsm+ subgroup. Four patients randomized to the ficlatuzumab (F) added to the gefitinib (G) treatment arm (G+F arm) did not receive the drug and survival was censored at baseline. Medians for each treatment arm are shown in the tables. CI, confidence interval; NR, not reached. Journal of Thoracic Oncology 2016 11, 1736-1744DOI: (10.1016/j.jtho.2016.05.038) Copyright © 2016 International Association for the Study of Lung Cancer Terms and Conditions

Figure 3 Kaplan-Meier curves by treatment arm and VeriStrat status for (A) progression-free survival (PFS) in the intent-to treat (ITT) population, (B) overall survival (OS) in the ITT population, (C) PFS in the ITT population (the subgroup with an EGFR TKI–sensitizing mutation [EGFRsm+]), and (D) OS in the ITT population (EGFRsm+). Medians for each subgroup is shown in the tables. G, gefitinib treatment arm; G+F, ficlatuzumab added to gefitinib treatment arm; VS-G, VeriStrat good; VS-P, VeriStrat poor; CI, confidence interval; NR, not reached. Journal of Thoracic Oncology 2016 11, 1736-1744DOI: (10.1016/j.jtho.2016.05.038) Copyright © 2016 International Association for the Study of Lung Cancer Terms and Conditions