RNS Number : 6416Z
17 May 2023
17 May 2023
Tagrisso plus chemotherapy demonstrated strong improvement in
progression-free survival for patients with EGFR-mutated advanced
lung cancer in FLAURA2 Phase III trial
Results support potential for a new treatment option that builds
the benefit of first-line standard of care Tagrisso
Positive high-level results from the FLAURA2 Phase III trial
showed AstraZeneca's Tagrisso (osimertinib) in combination with
chemotherapy demonstrated a statistically significant and
clinically meaningful improvement in progression-free survival
(PFS) compared to Tagrisso alone for patients with locally advanced
(Stage IIIB-IIIC) or metastatic (Stage IV) epidermal growth factor
receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Safety results and discontinuation rates due to adverse events
were consistent with the established profiles of each medicine. A t
the time of this analysis, the overall survival (OS) data were
immature and will be formally assessed at a subsequent
Each year, there are an estimated 2.2 million people diagnosed
with lung cancer globally with 80-85% of patients diagnosed with
NSCLC, the most common form of lung cancer.(1-3) Approximately 70%
of people are diagnosed with advanced NSCLC. Additionally, about
10-15% of NSCLC patients in the US and Europe, and 30-40% of
patients in Asia have EGFRm NSCLC.(4-6)
Pasi A. Jänne, MD, PhD, medical oncologist at Dana-Farber Cancer
Institute and principal investigator for the FLAURA2 trial, said: "
As the global standard of care for EGFR-mutated non-small cell lung
cancer, osimertinib monotherapy has transformed the treatment
landscape allowing many patients the opportunity to achieve
improved survival. FLAURA2 provides compelling evidence that the
addition of chemotherapy to osimertinib can provide a new option
for patients and clinicians that further improves outcomes compared
to osimertinib alone and as such, can further delay treatment
resistance and disease progression."
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: " These significant FLAURA2 results show
Tagrisso has the potential to offer patients in the first-line
setting a new treatment option that can extend the time they live
without their disease progressing. This meaningfully builds on
successive trials which have demonstrated improved clinical benefit
with Tagrisso in patients with EGFR-mutated lung cancer. "
The data will be presented at a forthcoming medical meeting and
shared with global health authorities.
These results add to the extensive body of evidence for Tagrisso
in EGFRm NSCLC, which has improved patient outcomes in both
early-stage disease in the ADAURA Phase III trial and late-stage
disease in the FLAURA Phase III trial. Tagrisso has also shown
proven clinical activity in treating central nervous system (CNS)
metastases across settings.
As part of AstraZeneca's ongoing commitment to treating patients
as early as possible in lung cancer, Tagrisso is also being
investigated in unresectable NSCLC in the pivotal LAURA Phase III
trial, with results expected later this year.
Lung cancer is the leading cause of cancer death among both men
and women, accounting for about one-fifth of all cancer deaths.(1)
Lung cancer is broadly split into NSCLC and small cell lung
cancer.(2) The majority of all NSCLC patients are diagnosed with
Patients with EGFRm NSCLC are particularly sensitive to
treatment with an EGFR-tyrosine kinase inhibitor (EGFR-TKI) which
blocks the cell-signaling pathways that drive the growth of tumour
FLAURA2 is a randomised, open-label, multi-centre, global Phase
III trial in the 1st-line treatment of 586 patients with locally
advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC.
Patients were treated with Tagrisso 80mg once daily oral tablets in
combination with chemotherapy (pemetrexed (500mg/m2) plus cisplatin
(75mg/m2) or carboplatin (AUC5)) every three weeks for four cycles,
followed by Tagrisso with pemetrexed maintenance every three
The trial was enrolled in more than 150 centres across more than
20 countries, including in the US, Europe, South America and Asia.
This is the final analysis of the primary endpoint of PFS. The
trial is ongoing and will continue to assess the secondary endpoint
Tagrisso (osimertinib) is a third-generation, irreversible
EGFR-TKI with proven clinical activity in NSCLC, including against
CNS metastases. AstraZeneca continues to explore Tagrisso as a
treatment for patients across multiple stages of EGFRm NSCLC.
Tagrisso is approved as monotherapy in more than 100 countries
including in the US, EU, China and Japan. These include for
1st-line treatment of patients with locally advanced or metastatic
EGFRm NSCLC, locally advanced or metastatic EGFR T790M
mutation-positive NSCLC, and adjuvant treatment of early-stage (IB,
II and IIIA) EGFRm NSCLC, where Tagrisso recently demonstrated a
statistically significant and clinically meaningful OS benefit.
In addition to investigating Tagrisso and chemotherapy in
late-stage disease (FLAURA2), AstraZeneca has several ongoing Phase
III trials focused on earlier stages of lung cancer. Tagrisso is
being tested in the neoadjuvant resectable setting (NeoADAURA), in
the Stage IA2-IA3 adjuvant resectable setting (ADAURA2), and in the
Stage III locally advanced unresectable setting (LAURA).
The Company is also researching ways to address tumour
mechanisms of resistance through the SAVANNAH and ORCHARD Phase II
trials, and the SAFFRON Phase III trial, which test Tagrisso given
concomitantly with savolitinib, an oral, potent and highly
selective MET TKI, as well as other potential new medicines.
AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer
to cure through the detection and treatment of early-stage disease,
while also pushing the boundaries of science to improve outcomes in
the resistant and advanced settings. By defining new therapeutic
targets and investigating innovative approaches, the Company aims
to match medicines to the patients who can benefit most.
The Company's comprehensive portfolio includes leading lung
cancer medicines and the next wave of innovations, including
Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi (durvalumab)
and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and
datopotamab deruxtecan in collaboration with Daiichi Sankyo;
Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a
pipeline of potential new medicines and combinations across diverse
mechanisms of action.
AstraZeneca is a founding member of the Lung Ambition Alliance,
a global coalition working to accelerate innovation and deliver
meaningful improvements for people with lung cancer, including and
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the
ambition to provide cures for cancer in every form, following the
science to understand cancer and all its complexities to discover,
develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers.
It is through persistent innovation that AstraZeneca has built one
of the most diverse portfolios and pipelines in the industry, with
the potential to catalyse changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and follow the
Company on Twitter @AstraZeneca .
For details on how to contact the Investor Relations Team,
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1. World Health Organisation. International Agency for Research
on Cancer. Lung Fact Sheet. Available at:
Accessed May 2023.
2. LUNGevity Foundation. Types of Lung Cancer. Available at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. Accessed May 2023.
3. Cheema PK, et al. Perspectives on treatment advances for
stage III locally advanced unresectable non-small-cell lung cancer.
Curr Oncol. 2019;26(1):37-42.
4. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on
Cytological and Histological Samples in Non-Small Cell Lung Cancer:
a Polish, Single Institution Study and Systematic Review of
European Incidence. Int J Clin Exp Pathol. 2013:6;2800-12.
5. Keedy VL, et al. American Society of Clinical Oncology
Provisional Clinical Opinion: Epidermal Growth Factor Receptor
(EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell
Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor
Therapy. J Clin Oncol. 2011:29;2121-27.
6. 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.
7. Cagle P, et al. Lung Cancer Biomarkers: Present Status and
Future Developments. Archives Pathology Lab Med.
8. Cross DA, et al. AZD9291, an Irreversible EGFR TKI, Overcomes
T790M-Mediated Resistance to EGFR Inhibitors in Lung Cancer. Cancer
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(END) Dow Jones Newswires
May 17, 2023 02:00 ET (06:00 GMT)
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