Early Developments of New Agents in Asia Yung-Jue Bang Professor of Medical Oncology Director, Clinical Trials Center Seoul National University Hospital
Q1 10
Why Asia? • Resources
Why Asia? • Resources • Market
Why Asia? • Resources • Market •  Epidemiologic difference
Incidence | Mortality
< 7.2 < 4.6 < 16.9  ■ < 62.2 < 10.7 Data source: Globocan 2008 (IARC) 8 2 2011
• Resources • Market • Epidemiologic difference • Ethnic difference

O’Donnel PH & Dolan ME. Clin Cancer Res 2009

Response    Gr ¾ Diarrhea
¹Taguchi T et al. Jpn J Cancer Chemother 1997, Hirata K et al. Clin Cancer Res 1999; ²van Groeningen CJ et al. JCO 2000; ³Hoff PM et al. Clin Cancer Res 2003
*schedule; 80 mg/m²/day for 28 days ¹Chollet P et al. Eur J Cancer 2003; ²Ohtsu et al. Br J cancer 2000; ³Jeung HC et al. Oncologist 2007
¹Hirata K et al. Clin Cancer Res 1999; ²van Groeningen CJ et al. JCO 2000; ³Hoff PM et al. Clin Cancer Res 2003
Patients with CR or 50 PR (%) Japanese (n=102) Non-Japanese (n=106) Fukuoka M et al. JCO 2003:21:2237-46
Time (months) Thatcher N, et al. Lancet 2005;366:1527-37
VOLUME 23 · NUMBER 11 · APRIL 10 2000 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L  R E P O R T . . . Predictive and Prognostic Impact of Epidermal Growth Factor Receptor Mutation in Non–Small-Cell Lung Cancer Patients Treated With Gefitinib . Sae-Wou Han, Tae-You Kau, Fil Gau Hwarg, Saohrun Javag, Javagni Kim, In Sd Cho Do-Yoau Ok, Jee Hyan Kim, Dong-War Kim, Doo Hyan Orung, Seock-Ah Im, Yoang Tee Jong Seak Lee, Dae Seog Heo, Yang-Jae Baug, and Noe Kreen, 90 NSCLC pts treated with gefitinib 17 (18.9%) had EGFR mutation 15/17 (88.2%) benefited from gefitinib including 11 PR RR 64.7%  vs. 13.7% (p<0.001) Seaul 110-244 Coax e-mail kintell J Clin Oncol 23:2493-2501. © 2005 by American Sociaty of Clinical Oncology CLINICAL TRIALS (ISTs only) ↑ Source: www.clinicaltrials.gov, 2010. 12. 31
Kang YK et al. ASCO 2010
Clinical trial magnifier 2009
Cilnicaltrials.gov(Oct 2005 – Jul 2009, interventional studies only)

Research ward: Established on June 15, 1997 Designated as the Regional Clinical Trials Center by the MOHW in Dec., 2004 Clinical Activity of the Oral ALK Inhibitor, Crizotinib (PF-02341066), in Patients with ALK-positive Non-small Cell Lung Cancer Bang Y,¹ Kwak EL,² Shaw A,² Camidge DR,³ lafrate AJ,² Maki RG,¹ Solomon B,5 Ou SI,6 Salgia R,7 Clark J² ¹Seoul National University, Seoul, Korea; ²Massachusetts General Hospital, Boston, MA, USA; ³University of Colorado Cancer Center, Aurora, CO, USA; 4Memorial Sloan-Kettering Cancer Center, New York, NY, USA; 5Peter MacCallum Cancer Centre, East Melbourne, Australia; 6University of California at Irvine, Irvine, CA, USA; 7University of Chicago Cancer Center, Chicago, IL, USA ASCOAhriual Meeting 2010
*Partial response patients with 100% change have non-target

Kim SY, et al. Int J Oncol 2008;32:89-95

HER-2 FISH FISH status

Im SA, et al. in press

•  Participation of Asians in early oncology trials is essential considering potential ethnic differences. •  It could improve efficiency and effectiveness of clinical trials. •  We need to contribute more to translational and/or early clinical trials. •  Japan-Korea collaboration can further enhance the efficiency of early oncology trials.