Tagrisso® (osimertinib) demonstrates superiority over chemotherapy in EGFR T790M mutation-positive non-small cell lung cancer

First randomized Phase III trial (AURA3) of Tagrisso against chemotherapy

Tagrisso reduced risk of disease progression by 70 per cent and improved progression-free survival (PFS) by almost six months

MISSISSAUGA, ON, Dec. 9, 2016 /CNW/ - AstraZeneca recently presented data from the AURA3 phase III trial showing that Tagrisso (osimertinib) second-line therapy improved progression-free survival (PFS) by 5.7 months compared with standard platinum-based doublet chemotherapy (Hazard Ratio [HR]=0.3).1 The results were presented at the 17th World Conference on Lung Cancer (WCLC) in Vienna, Austria, hosted by the International Association for the Study of Lung Cancer and published simultaneously online in The New England Journal of Medicine.                                                     

"The confirmatory Phase III data demonstrate the clinical benefit of Tagrisso for patients who have progressed following EGFR tyrosine kinase inhibitor treatment," says Dr. Neil Maresky, Vice President, Scientific Affairs at AstraZeneca Canada. "As lung cancer is the most common type of cancer to spread to the brain, it is also encouraging to see the activity of Tagrisso in patients with central nervous system metastases who have limited treatment options and whose prognosis is often particularly poor."

AURA3 data showed Tagrisso offered a statistically-significant improvement in PFS versus standard platinum-based doublet chemotherapy (10.1 months vs 4.4 months, hazard ratio [HR] 0.30; 95% confidence interval (CI):0.23, 0.41; p<0.001).1 In the 34 per cent of patients with central nervous system (CNS) metastases at baseline, PFS was also significantly greater with Tagrisso than with platinum-based doublet chemotherapy (8.5 months vs 4.2 months, HR 0.32; 95% CI: 0.21, 0.49).1

"AURA3 results show that Tagrisso, a new targeted oral treatment, is largely superior to standard chemotherapy for the subset of lung cancer patients with EGFR mutation who have progressed after first-line treatment with a tyrosine kinase inhibitor and have a T790M mutation," says Dr. Benoît Samson, Hematologist and Medical Oncologist at the Centre intégré de cancérologie de la Montérégie (CICM) of the CISSS de la Montérégie-Centre and professor in the Faculty of Medicine and Health Sciences at the Université de Sherbrooke. "The significant clinical benefit and safety profile of Tagrisso make it the best treatment choice for these patients, providing a new way to battle this devastating disease."

The AURA3 safety data for Tagrisso were in line with previous experience. Grade ≥3 drug-related adverse events (AEs) were reported in 6 per cent of patients (n=16) treated with Tagrisso and 34 per cent (n=46) treated with platinum-based doublet chemotherapy.1 The most common drug-related AEs in the Tagrisso group, were diarrhea (29% overall; 1% Grade ≥3) and rash (28% overall; <1% Grade ≥3) and, in the chemotherapy group, they were nausea (47% overall; 3% Grade ≥3) and decreased appetite (32% overall; 3% Grade ≥3).2

The data for AURA3 are consistent with those previously presented in the Phase II trials, AURA2 and AURA extension. This consistency extends to testing of tissue and plasma samples for the detection of the EGFR T790M resistance mutation. In AURA3, approximately half of patients with T790M in tumour tissue also had the T790M mutation detected in plasma.1 Clinical benefits were reported with Tagrisso compared to platinum-based doublet chemotherapy, irrespective of whether the T790M mutation was identified by plasma ctDNA or tissue testing. When feasible, tissue testing is recommended for patients with a negative plasma T790M test.1

In Canada, Tagrisso was reviewed under Health Canada's accelerated approval framework. It was granted the Notice of Compliance with Conditions (NOC/c) earlier this year, based on promising evidence of clinical efficacy data, pending the results of additional trials to verify its clinical benefit, for the first treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after EGFR tyrosine kinase inhibitor therapy (TKI).3 A validated test is required to identify EGFR T790M mutation-positive status prior to treatment.

About AURA31
AURA3 compared the efficacy and safety of Tagrisso 80mg once daily and platinum-based doublet chemotherapy (platinum-pemetrexed) in 419 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC whose disease had progressed on or after treatment with a previous EGFR tyrosine kinase inhibitor (TKI). The trial was carried out in more than 130 locations worldwide, including Canada, the USA, Europe, China, Japan, Korea, Taiwan and Australia.

The primary endpoint of the trial was PFS, and secondary endpoints included overall survival (OS), overall response rate (ORR), duration of response (DoR), disease control rate (DCR), safety and measures of health-related quality of life (HRQoL).

About Non-Small Cell Lung Cancer (NSCLC)
On average, 57 Canadians die from lung cancer every day4 – that's more than 20,000 each year.5 In fact, more people die from lung cancer than breast cancer, colorectal cancer and prostate cancer combined.4 NSCLC is the most common form of lung cancer and accounts for 85 to 90 per cent of all lung cancers in Canada.6 Often diagnosed in late stage, fewer than 17 per cent of patients diagnosed with NSCLC will live more than five years following diagnosis.4 Ethnicity can increase risk for genetic mutations in NSCLC. In Caucasian populations, 10 to 15 per cent of all NSCLC diagnoses are EGFR mutation-positive, but this climbs to 30 to 40 per cent in people of Asian background with NSCLC.7 Also, NSCLC patients with the EGFR T790M mutation are more likely to be female and to have never smoked.8

About Tagrisso
Tagrisso (osimertinib, AZD9291) 80mg once daily tablet is approved in Canada, the US, EU, Japan, Switzerland, Israel, Mexico, South Korea, Australia and a number of other countries as the first treatment for patients with locally-advanced or metastatic EGFR T790M mutation-positive NSCLC. Eligibility for treatment with Tagrisso is dependent on confirmation that the EGFR T790M mutation is present in the tumour.3

Tagrisso has one of the fastest development programs, from start of clinical trials to approval in just over two and a half years. Tagrisso is as an irreversible EGFR inhibitor, born out of scientific exploration and engineered to combat the mechanism of resistance by targeting the T790M resistance mutation. Tagrisso is also investigated in the adjuvant and metastatic first-line settings, including in patients with and without brain metastases, in leptomeningeal disease, and in combination with other treatments.3

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on three important areas of healthcare: Cardiovascular and Metabolic disease; Oncology; and Respiratory, Inflammation and Autoimmunity. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ more than 675 employees across the country and our AstraZeneca Canada headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at www.astrazeneca.ca.

REFERENCES:

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1 Mok T.S., et al. Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer. The New England Journal of Medicine. Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1612674#t=articleMethods. Accessed on December 7, 2016.
2 AstraZeneca Data On File.
3 TAGRISSO™ (osimertinib) Product Monograph. Available at: https://www.astrazeneca.ca/content/dam/az-ca/downloads/productinformation/TAGRISSO%20-%20Product-Monograph.pdf. Accessed on December 7, 2016.
4 Lung Cancer Canada. 2015 Faces of Lung Cancer Report. Available at: http://www.lungcancercanada.ca/getmedia/7f1ad2f4-2bb0-45e8-9bf5-d4fa01779a68/The-Faces-of-Lung-Cancer-2015.aspx. Accessed on December 7, 2016.
5 Canadian Cancer Society. Canadian Cancer Statistics 2015. Available at: http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2015-EN.pdf?la=en. Accessed on December 7, 2016.
6 Molina JR, et al. Non-small cell lung cancer: Epidemiology, risk factors, treatment and survivorship. Mayo Clin Proc. 2008 May; 83(5): 584-594.
7 Ellison G, et al. EGFR mutation testing in lung cancer: a review of available methods and their use for analysis of tumour tissue and cytology samples. J Clin Pathol. 2013; 66: 79-89.
8 Gazdar A, et al. Hereditary lung cancer syndrome targets never smokers with germline EGFR gene T790M mutations. Thorac Oncol. 2014 April; 9(4): 456–463.

SOURCE AstraZeneca Canada Inc.

For further information: Michael Kohn, Account Manager, Healthcare, Weber Shandwick, Tel: 416-642-7914, Email: mkohn@webershandwick.com; Michelle Marchione, Senior Manager, Corporate Communications, AstraZeneca Canada, Tel: 905-803-5749, Email: michelle.marchione@astrazeneca.com

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