Doctor Letter Regarding Iressa (gefitinib) ISEL Data
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Mary Lynn Carver
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Rachel Bloom-Baglin
AstraZeneca Media Relations |
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A double blind, placebo controlled, parallel group, mulitcentre, randomised, Phase III survival study comparing IRESSA® (gefitinib) (250mg tablet) plus Best Supportive Care versus placebo plus Best Supportive Care in patients with Advanced NSCLC who have received one or two prior chemotherapy regimens and are refractory or intolerant to their most recent regimen
December 17, 2004 -
Dear Doctor,
I am writing to inform you that AstraZeneca has just analyzed the top-line data from the ISEL trial, a trial which compared IRESSA® (gefitinib) to placebo in advanced non-small cell lung cancer patients who had progressed or could no longer tolerate chemotherapy.
The trial was closed to randomization on August 2, 2004 with 1692 enrolled patients. The analysis of the primary endpoint of the study shows that IRESSA did not significantly prolong survival in the overall population (HR 0.89, p=0.11, Median 5.6 vs 5.1 months for IRESSA and placebo respectively), or in patients with adenocarcinoma (HR 0.83, p=0.07, Median 6.3 vs 5.4 months for IRESSA and placebo respectively). In addition, an unconfirmed objective response rate for IRESSA of 8.2% was observed, which did not translate into an overall statistically significant survival benefit. There is no methodological explanation for these study findings and analysis of EGFR status and other biomarkers is still underway for ISEL and other ongoing studies.
AstraZeneca is providing the ISEL data to you in a rapid fashion to enable you to best treat your current and future patients. In light of positive survival data with other agents including another oral EGFR inhibitor, AstraZeneca urges you to consider other treatment options in the recurrent non-small cell lung cancer patient population. Individual patients currently on IRESSA and doing well may be part of a patient group that might derive benefit from IRESSA. AstraZeneca plans to evaluate further which patient groups may derive benefit from IRESSA.
These top line results are currently being reviewed and discussed with the FDA. Full results of the data will be available in the first half of 2005 and publicly presented as soon as possible. For those individual patients whom you feel are benefiting and deem appropriate, AstraZeneca intends to continue to make the drug available. At this time, AstraZeneca is suspending promotion of Iressa while these trial data are further analyzed.
Please do not hesitate to contact the AstraZeneca Cancer Support Network at 866-992-9276 for further clarification of your questions.
