Gefitinib (IRESSA™) Lung Cancer ISEL Trial Shows No Overall Survival Advantage In A Highly Refractory Population
| Media contacts | |
|
Rachel Bloom-Baglin
AstraZeneca Media Relations (US) |
(302) 886-7858 |
|
Mary Lynn Carver
AstraZeneca Media Relations (US) |
(302) 886-7859 |
|
Edel McCaffrey
AstraZeneca Media Enquiries (UK) |
+44 (0) 207 304 5034 |
|
Steve Brown
AstraZeneca Media Enquiries (UK) |
+44 (0) 207 304 5033 |
|
Mina Blair
AstraZeneca Investor Enquiries (UK) |
+44 (0) 207 304 5084 |
|
Jonathan Hunt
AstraZeneca Investor Enquiries (UK) |
+44 (0) 207 304 5087 |
December 17, 2004 - Wilmington, DE - AstraZeneca today announced that the initial analysis of the primary endpoint of Study 709, IRESSA Survival Evaluation in Lung cancer (ISEL) with 1692 patients has been conducted, and shows that IRESSA failed to significantly prolong survival in comparison to placebo in the overall population (HR 0.89, p=0.11, Median 5.6 vs 5.1 months), or in patients with adenocarcinoma (HR 0.83, p=0.07, Median 6.3 vs 5.4 months). There was a statistically significant improvement in tumour shrinkage (objective response rate), which did not translate into a statistically significant survival benefit. Prospective subgroup analyses suggested survival benefits in patients of Oriental origin and in patients who never smoked.
“The trial was well designed, the data are robust and there is no methodological explanation for these findings. Full results from ISEL will be presented in the first half of 2005,” commented Professor Nick Thatcher, Principal Investigator for the ISEL study.
“ISEL was a large well conducted study that demonstrated a similar objective response rate to that seen in the erlotinib study BR21 but, disappointingly, this did not result in an overall survival benefit.” commented Dr Alan Barge, Worldwide Medical Director for IRESSA. “Iressa clearly provides substantial benefits for some patients in clinical practice and we will be working to better understand this outcome including evaluation of EGFR expression and other biomarkers.”
AstraZeneca is now actively consulting with Regulatory Authorities to determine the impact of these data and intends to honour a commitment to continue to supply IRESSA to any patient receiving the drug who, in consultation with their physician, wishes to continue treatment. Patients currently being prescribed IRESSA should continue to take their medication and should consult their physician about their ongoing treatment at the first opportunity.
