A	B	C
1	Main
2		Brand Name	Iressa
3		Generic Name	gefitinib
4		Mechanism	EGFR kinase inhibitor
5		Subsets	Never-smokers, Asians and adenocarcinoma patients have better survival with EGFr inhibitors than smokers, non-Asians and squamous cell patients.
6			Women might have higher response rates than men.
7			17% of patients have EGFR mutations (Spain, NEJM 2009).
8		Competition	Tarceva, (OSIP/Roche).
9		IP	5457105 describes compound and expires in 2013. 5770599 describes compound and expires in 2017.
10		Papers	Gefitinib or Carboplatin-Paclitael in Pulmonary Adenocarcinoma. Mok et al. NEJM 361;10:947-957.
11		Clinical Trials
12			Phase III "IPASS" Gefitinib vs Carbo-Tax n=1217 in 1L NSCLC Asian non-smoker/light-smoker. ESMO 2008 presentation.
13			12-month PFS of 24.9% vs 6.7% in ITT, HR=0.74. median PFS similar: 5.7m vs. 5.8m. HR for OS =0.91 (18.6m vs 17.3m).
14			n=261 were EGFR+ and HR =0.48. (Only 437 bio markers could be analyzed).
15			n=176 were EGFR- and HR=2.85.
16
17			Phase III INTEREST - Iressa vs Taxotere in 2L NSCLC - Lancet 2008 - 2004-2006 recruitment.
18			Met non-inferiority with 7.6mo vs 8.0mo, HR=1.02 OS. Missed superiority in high-copy EGFR with 8.4mo vs 7.5mo.
19			n=1466 all receiving 1L platinum. Study was open-label. Co-primary endpoints of non-inferior MOS and superior MOS for Iressa in high-copy EGFr status.
20
21			Phase III INVITE 1L NSCLC patients unsuited for chemotherapy
22
23			Phase III ISEL - Iressa vs placebo
24			Fails superiority primary endpoint. 5.6 vs 5.1mo. P=0.09. 90% refractory to chemo.
25
26			Phase II SIGN
27
28			Phase III V-15-32 Japan n=489
29
30
31			Phase III BR.21 - Tarceva vs placebo
32			6.7mo vs 4.7mo, SS MOS improvement.