新藥 PF00299804(PF299)的新聞,看不太懂,有人好心翻一下嗎? - 抗癌

來源:ASCO
原文:

http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=41244

縮址:http://tinyurl.com/69jdarz


Sub-category:
Metastatic

Category:
Lung Cancer - Metastatic

Meeting:
2010 ASCO Annual Meeting

Session Type and Session Title:
General Poster Session, Lung Cancer - Metastatic

Abstract No:
7599

Citation:
J Clin Oncol 28:15s, 2010 (suppl; abstr 7599)

Author(s):
K. Park, D. S. Heo, B. Cho, D. Kim, M. Ahn, S. Lee, R. D. Millham, A.
Campbell, H. Zhang, J. Kim; Samsung Medical Center, Sungkyunkwan University
School of Medicine, Seoul, South Korea; Seoul National University Hospital,
Seoul, South Korea; Yonsei Cancer Center, Yonsei University Health System,
Seoul, South Korea; Samsung Medical Center, Seoul, South Korea; Pfizer,
Korea, Seoul, South Korea; Pfizer, Inc., New London, CT; Pfizer Research and
Development Co. Ltd., Shanghai, China; Yonsei Cancer Center, Yonsei
University College of Medicine, Seoul, South Korea

Abstract:

Background: PF299 is an oral, irreversible, small molecule inhibitor of the
human epidermal growth factor receptor (HER)-1, -2, and -4 tyrosine kinases.
Trials in Western pts identified a recommended phase II dose (RP2D) of PF299
45 mg once daily (QD) and reported antitumor activity in NSCLC. We present a
P1/2, multicenter, open-label study of Korean pts with KRAS wild-type NSCLC
(adenocarcinoma histology) refractory to platinum-based CT and E or G.
Methods: In the P1 dose-finding study portion, 12 pts received PF299,
starting with 30 mg QD, to identify the RP2D and evaluate safety. Following
P1, pts were enrolled in a Fleming single-stage P2 study and received the
PF299 RP2D, 45 mg QD. Endpoints included progression-free survival rate at 4
months (PFS4m; primary), overall survival rate at 6 months (OS6m), objective
response rate (ORR), safety, pharmacodynamic (PD) biomarkers (HER-1/-2
extracellular domain), serum and tumor KRAS and HER-1 genetic analyses, and
patient-reported outcomes (PROs) measured by EORTC QLQ-C30/LC13. Results: In
P2, 30 pts of 42 planned have enrolled to date, of whom 87% had received


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