HONG KONG, Sept. 19 /Xinhua-PRNewswire/ -- Data presented at the European Society of Medical Oncology (ESMO) meeting in Stockholm show that the IRESSA Pan-ASia Study (IPASS) exceeded its primary objective, demonstrating superior progression-free survival (PFS) for the oral anti-cancer drug gefitinib, compared with intravenous carboplatin/paclitaxel chemotherapy (Hazard ratio [HR] 0.74, 95% confidence interval [CI] 0.65 to 0.85, p<0.0001) in the overall population of clinically selected patients with advanced NSCLC in Asia.(1)
In pre-planned analyses of subgroups defined by the biomarker status of the patient's tumour, PFS was significantly longer for gefitinib than chemotherapy in patients with EGFR mutation positive tumours (HR 0.48, 95% CI 0.36 to 0.64, p<0.0001), and significantly longer for chemotherapy than gefitinib in patients with EGFR mutation negative tumours (HR 2.85, 95% CI 2.05 to 3.98, p<0.0001). In the subgroup of patients whose EGFR mutation status was unknown, PFS was superior for gefitinib, consistent with the overall population.
Gefitinib also demonstrated a more favourable tolerability profile and superior quality of life improvement rates for patients versus chemotherapy.
IPASS was an open label, randomised, parallel-group study that assessed the efficacy, safety and tolerability of gefitinib versus carboplatin/paclitaxel as first-line treatment in a clinically selected population of patients from Asia. The primary endpoint of IPASS was PFS, with the objective of demonstrating that gefitinib was non-inferior to carboplatin/paclitaxel doublet chemotherapy.
The study enrolled 1,217 patients in Asia with advanced NSCLC who had not received prior chemotherapy for advanced disease, whose tumours were of adenocarcinoma histology and who had either never smoked, or were former light smokers (ceased smoking at least 15 years ago and <= 10 pack years exposure) (Note: Ten pack years is smoking 1 pack of cigarette a day for ten years, or smoking 10 packs of cigarette a day for one year, based on 20 cigarettes per pack).
For secondary endpoints, objective response rate was superior for gefitinib (43% vs. 32%; p=0.0001) and significantly more gefitinib-treated patients experienced a clinically important improvement in Quality of Life compared to carboplatin/paclitaxel (48% vs. 41%; p=0.0148 for Functional Assessment of Cancer Therapy - Lung [FACT-L] total score, and 46% vs. 33%; p<0.0001 for trial outcome index [TOI]). Overall survival whilst still immature was similar for both treatments (HR 0.91, 95% CI 0.76 to 1.10; 37% of patients had died). Further survival follow-up is ongoing.
The safety profile of gefitinib was generally consistent with its prescribing information, previous gefitinib studies in the relapsed setting, and underlying disease.
Lead Investigator, Professor Tony Mok (Hong Kong Cancer Institute, Chinese University of Hong Kong) said: "Gefitinib is a proven valuable alternative to chemotherapy in Asian patients with pre-treated advanced NSCLC. Results from the IPASS study mean that gefitinib (a single once-daily oral tablet) offers a potential new paradigm in the first line treatment of selected Asian patients with advanced NSCLC."
Gefitinib is not currently licensed for the first-line treatment of advanced NSCLC. AstraZeneca is in consultation with relevant health authorities regarding the IPASS data. Gefitinib currently has licences in 36 countries including 10 countries in Asia for the treatment of patients with locally advanced or metastatic NSCLC who have been pre-treated with chemotherapy, and in Japan for inoperable or recurrent NSCLC.
A marketing authorisation application was submitted in May 2008 to the European Medicines Agency (EMEA) for gefitinib following results from the Phase III international INTEREST (IRESSA Non-small-cell lung cancer Trial Evaluating REsponse and Survival against Taxotere) study, which showed that gefitinib provides equivalent survival with better tolerability and quality of life compared to standard chemotherapy (docetaxel) in the pre-treated setting in an unselected patient population.
Notes to editors
About lung cancer
-- Over 1.35 million new cases of lung cancer are diagnosed every year
worldwide and nearly 1.2 million people die as a result of this
devastating disease -- more than breast, colon and prostate cancer
combined.(2)
-- 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%.(3)
About AstraZeneca
-- AstraZeneca is a major international healthcare business engaged in
research, development, manufacturing and marketing of prescription
pharmaceuticals and supplier for healthcare services. AstraZeneca is
one of the world's leading pharmaceutical companies with healthcare
sales of US $29.55 billion and is a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infection
product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index.
-- For more information about AstraZeneca, please visit:
http://www.astrazeneca.com
Reference List
(1) Mok T. Phase III, Randomised, Open-Label, First-Line Study Of
Gefitinib Vs Carboplatin/Paclitaxel (C/P) In Clinically Selected
Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC), Presented
at the European Society of Medical Oncology meeting, Stockholm. Abs
LBA2. 2008.
(2) Ferlay, J. et al. GLOBOCAN 2002: Cancer Incidence, Mortality and
Prevalence Worldwide. IARC CancerBase No. 5. version 2.0. Lyon: IARC
Press, 2004.
(3) Bepler G. Lung cancer epidemiology and genetics. J Thorac Imaging
1999; 14(4):228-234.
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