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Two Phase Iii Studies Confirm Efficacy Of Iressa In EGFR MUTATION+ NSCLC

BERLIN, Thursday 24 September – New data presented this week at the joint ECCO-ESMO multidisciplinary congress in Berlin, show that AstraZeneca’s oral anti-cancer drug IRESSATM (gefitinib) provides significant efficacy benefits compared to doublet chemotherapy as a first-line treatment for patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC). These benefits include longer progression-free survival (PFS: the length of time a patient lives without their cancer growing or spreading) and higher objective response rates (ORR: tumour shrinkage). These data confirm results seen in the Phase III IPASS study1, and further support the need in the first-line setting to identify which form of advanced NSCLC a patient has through EGFR mutation testing.

Results from the Phase III Japanese WJTOG 3405 study2 in 177 randomised patients with EGFR mutation-positive advanced NSCLC, showed that PFS was significantly longer with IRESSA compared to cisplatin/docetaxel doublet chemotherapy as a first-line treatment (Hazard ratio [HR] 0.489, 95% confidence interval [CI] 0.336-0.710, p<0.001; median PFS 9.2 months vs. 6.3 months). ORR was also higher with IRESSA versus doublet chemotherapy (56.3% vs. 25.3%). IRESSA was generally well-tolerated in the study; the most common side effects with IRESSA were skin rash and liver dysfunction.

Another study presented this week, the Japanese NEJ002 study3, a Phase III first-line study in 200 randomised patients with EGFR mutation-positive advanced NSCLC, showed that PFS was significantly longer with IRESSA compared to carboplatin/paclitaxel doublet chemotherapy (HR 0.357, 95% CI 0.252-0.507, p<0.001; median PFS 10.4 months vs. 5.5 months). In addition, patients receiving IRESSA had significantly higher ORR (74.5% vs. 29.0%, p<0.001), and IRESSA demonstrated a favourable tolerability profile against doublet chemotherapy. Preliminary overall survival (OS) data show that there was a trend for OS to be longer with IRESSA, although no statistically significant differences were seen, possibly due to the large number of chemotherapy patients that crossed over to receive subsequent IRESSA therapy (HR 0.793, 95% CI 0.485-1.296, p=0.354; median survival 28.0 months vs. 23.6 months) Alison Armour, Medical Science Director at AstraZeneca, said: "IRESSA has demonstrated significant efficacy and tolerability benefits compared to doublet chemotherapy for the first-line treatment of EGFR mutation-positive NSCLC, and its approval in the EU in July this year marks a further step towards personalised treatment of this disease. It is essential that EGFR mutation testing becomes part of standard clinical practice to ensure that patients have access to the most effective treatment for their specific form of lung cancer."

In July 2009, IRESSA was approved in the EU for patients with locally advanced or metastatic NSCLC with activating mutations of EGFR-TK. AstraZeneca is currently consulting with other regulatory authorities around the world to discuss the potential use of IRESSA as a first-line treatment for patients with EGFR mutation-positive NSCLC.


Notes to editors The ECCO-ESMO meeting is the joint 15th Congress of the European CanCer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO) About IRESSA · Mode of Action: IRESSA is an EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor), which targets and blocks the activity of the EGFR-TK, an enzyme that regulates intracellular signalling pathways implicated in cancer cell proliferation and survival. Growth factor signalling has been identified as a key driver of tumour growth and spread in a wide range of cancers · IRESSA (250 mg) is a once-daily oral therapy · IRESSA is approved in the EU for the treatment of patients with locally advanced or metastatic NSCLC with activating mutation of EGFR-TK. Outside of Europe, IRESSA is licensed in 36 countries for the treatment of patients with locally advanced or metastatic NSCLC who have previously received chemotherapy · IRESSA has a well-established, generally well-tolerated side effect profile and is not typically associated with the cytotoxic side-effects commonly seen with chemotherapy. The most commonly seen side-effects of IRESSA are mild-to-moderate rash and diarrhoea.1 · To date, the number of patients who have taken gefitinib is over 300,000 and the maximum time a patient has remained on gefitinib therapy is in excess of eight years.

About lung cancer · Over 1.35 million new cases of lung cancer are diagnosed every year and nearly 1.2 million people die as a result of this devastating disease - more than breast, colon and prostate cancer combined.4

· Approximately 10-15% of NSCLC patients in Europe5-7 and 30-40% of NSCLC patients in Asia8;9 will have EGFR mutation positive NSCLC. · If lung cancer is detected at early stages, before it has spread to other organs or lymph nodes, around half of patients can survive for five years or more. However, few lung cancers are found at this early stage and it is normally diagnosed at the advanced stage, when five year survival falls to approximately 15%.10

About AstraZeneca AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit:<>

For further information, please contact: David Ginivan AstraZeneca Tel: +44 (0) 1625 516 973 Mobile: +44 (0) 7775 412 619




Reference List

(1) Mok. T et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. New England Journal of Medicine: 361(10); 947-957. 2009. (2) Tsurutani J. et al. A phase III, first-line trial of gefitinib versus cisplatin plus docetaxel for patients with advanced or recurrent non-small cell lung cancer (NSCLC) harboring activating mutation of the epidermal growth factor receptor (EGFR) gene: preliminary results of WJTOG 3405. Abstract 9.002. Presented at ECCO/ESMO. Berlin. 2009. (3) Inoue A. et al. A randomized phase III study comparing gefitinib with carboplatin (CBDCA) plus paclitaxel (TXL) for the first-line treatment of non-small cell lung cancer (NSCLC) with sensitive EGFR mutations: NEJ002 study. Abstract 9LBA. Presented at ECCO/ESMO, Berlin. 2009. (4) Ferlay, J. et al. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No. 5. version 2.0. Lyon: IARC Press, 2004. (5) Cortes-Funes H et al. Epidermal growth factor receptor activating mutations in Spanish gefitinib-treated non-small-cell lung cancer patients. Annals of Oncology. 16(7);1081-1086. 2005. (6) Rosell R, Moran T, Queralt C et al, Screening for epidermal growth factor receptor mutations in lung cancer, New England Journal of Medicine; 361: 958-967. 2009. (7) IRESSA Summary of product characteristics (8) Yoshida al. Prospective validation for prediction of gefitinib sensitivity by epidermal growth factor receptor gene mutation in patients with non-small cell lung cancer. Journal of Thoracic Oncology: 2(1); 22-28. 2007. (9) Tokumo al. The relationship between epidermal growth factor receptor mutations and clinicopathologic features in non-small cell lung cancers. Clinical Cancer Research: 11; 1167-1173. 2005. (10) Bepler G. Lung cancer epidemiology and genetics. J Thorac Imaging 1999; 14(4):228-234.


--------------------------------------------------------- Clare Jefferies Porter Novelli

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Posted: September 2009