Phase III FLAURA data, including new data in patients with CNS metastases, confirm Tagrisso as potential new standard of care as 1st-line therapy in EGFR-mutated NSCLC New data in EGFR mutation-positive NSCLC in Asian patients to be unveiled Presentation of the Phase III PACIFIC data highlight Imfinzi as the first Immuno-Oncology therapy to demonstrate efficacy in locally advanced (Stage III) unresectable NSCLC SINGAPORE -- (BUSINESS WIRE) -- At the ESMO Asia 2017 Congress in Singapore, 17-19 November 2017, AstraZeneca and MedImmune, its global biologics research and development arm, will share ground-breaking results from two pivotal trials, as well as new data from the FLAURA trial on central nervous system (CNS) metastases in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) and subset data in Asian patients. In oral presentations on 18 November 2017, key data will be presented on two Phase III trials in areas of high unmet medical need in Asia:
Joris Silon, Asia Area Vice President at AstraZeneca, said: “The paradigm-shifting results of the FLAURA trial of Tagrisso and PACIFIC trial of Imfinzi demonstrate two new potential standards of care for patients with lung cancer. Our commitment to improving outcomes in this tumour type extends from earlier- to late-stage disease and encompasses a wide array of scientific approaches that leverage different mechanisms to attack cancer. The lung cancer burden is significant in Asia, and we are proud to share our progress with the medical community.” FLAURA: Demonstrating unprecedented PFS in 1st-line EGFR mutation-positive NSCLC AstraZeneca will present the full results of the Phase III FLAURA trial, which support Tagrisso’s clear potential as a new standard of care (SoC) in the 1st-line treatment of adult patients with locally advanced or metastatic EGFR-mutated (EGFRm) NSCLC. The results, which will be presented during the oral session on 18 November from 09:45-09:57 in Hall 405, demonstrate a superior, clinically meaningful progression-free survival (PFS) advantage with Tagrisso compared with current SoC EGFR tyrosine kinase inhibitors (TKIs) erlotinib or gefitinib. In the trial, osimertinib significantly improved PFS compared with erlotinib or gefitinib in previously untreated patients; median PFS was nearly doubled at 18.9 months for osimertinib compared with 10.2 months for the EGFR-TKI comparator arm (PFS, hazard ratio [HR] 0.46; 95% confidence interval [CI] 0.37-0.57; p<0.0001). Preliminary overall survival (OS) data favoured osimertinib with a 37% reduction in the risk of death (HR 0.63, 95% CI 0.45-0.88; p=0.0068 [not significant]) at the interim OS analysis (25% maturity). The FLAURA safety data for Tagrisso were in line with those observed in prior clinical trials. Tagrisso was well tolerated, with less frequent grade 3 or higher adverse events (AEs) than with standard EGFR-TKIs (34% vs. 45%). In patients treated with osimertinib, the most common AEs were diarrhoea (58% [2% Grade ≥3]) and dry skin (32% [<1% Grade ≥3]), and in the comparator arm group, the most common AEs were diarrhoea (57% [3% Grade ≥3]) and dermatitis acneiform (48% [5% Grade ≥3]). Dr. Yuichiro Ohe, from the National Cancer Centre Hospital, Tokyo, Japan, said: “The FLAURA data are extremely encouraging and provide new hope for improved outcomes in an area of great unmet medical need. The impressive efficacy improvements and favourable safety profile for Tagrisso support its use as the new standard of care as 1st-line therapy in EGFR-mutated NSCLC.” In addition to the overall FLAURA trial results, AstraZeneca is reporting new data at the ESMO Asia 2017 Congress:
Dr. Byoung-Chul Cho, Associate Professor, Yonsei University College of Medicine, Seoul, Korea, said: “The burden of lung cancer, particularly EGFRm disease, is especially high among Asian populations. The commitment to further research in this population is exciting and offers the promise of potentially meaningful clinical advances for patients.” In Asia, 30-40% of all patients with NSCLC have EGFRm disease, the highest prevalence among any ethnic group. PACIFIC: Demonstrating the first superior PFS in locally advanced (Stage III), unresectable NSCLC AstraZeneca is also presenting full results of a planned interim analysis of the Phase III PACIFIC trial, which show that Imfinzi demonstrated a statistically significant and clinically meaningful improvement in PFS compared to current SoC with active surveillance in patients with locally advanced (Stage III), unresectable NSCLC who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy (CRT). Imfinzi is the first Immuno-Oncology medicine to show superior PFS in this setting. The results, which will be presented during the oral session on 18 November from 09:33-09:45 in Hall 405, show an improvement in PFS of more than 11 months in patients treated with Imfinzi compared to placebo. The PFS improvement with Imfinzi was observed across all pre-specified subgroups, including PD-L1 expression status. Patients receiving Imfinzi also had a lower incidence of metastases than those receiving placebo. The PACIFIC trial continues to evaluate OS, the other primary endpoint. Detailed results of the PACIFIC trial are published online in the New England Journal of Medicine. Among patients receiving Imfinzi, the most frequent treatment-related AEs vs. placebo were cough (35.4% vs. 25.2%), pneumonitis/radiation pneumonitis (33.9% vs. 24.8%), fatigue (23.8% vs. 20.5%), dyspnoea (22.3% vs. 23.9%) and diarrhoea (18.3% vs. 18.8%). 29.9% of patients experienced a grade 3 or 4 AE vs. 26.1% for placebo, and 15.4% of patients discontinued treatment due to AEs compared to 9.8% of patients on placebo. AstraZeneca is in discussions with global health authorities regarding regulatory submissions for Imfinzi based on the PACIFIC data. NOTES TO EDITORS
About NSCLC
About Tagrisso
About FLAURA
About Locally Advanced (Stage III) NSCLC
About Imfinzi Imfinzi has already received accelerated approval in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. As part of a broad development programme, Imfinzi is also being investigated for the adjuvant treatment of patients with NSCLC in the CCTG (Canadian Cancer Trials Group) trial ADJUVANT (BR31). In the MYSTIC, NEPTUNE, and PEARL Phase III trials, Imfinzi is being studied for 1st-line treatment as monotherapy and/or in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody, for the treatment of metastatic NSCLC. The POSEIDON trial is investigating Imfinzi with and without tremelimumab in combination with chemotherapy in the same population.
About PACIFIC The trial is being conducted in 235 centres across 26 countries involving approximately 700 patients. The primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS), and secondary endpoints include landmark PFS and OS, objective response rate (ORR) and duration of response.
About AstraZeneca in Lung Cancer
About AstraZeneca in Oncology By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
About MedImmune
About AstraZeneca For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
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