Results support potential for a new
treatment option that builds on the benefit of first-line standard
of care TAGRISSO monotherapy
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. At
the time of this analysis, the overall survival (OS) data were
immature and will be formally assessed at a subsequent
analysis.
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.
IMPORTANT SAFETY INFORMATION
- There are no contraindications for TAGRISSO
- Interstitial lung disease (ILD)/pneumonitis occurred in 3.7% of
the 1479 TAGRISSO-treated patients; 0.3% of cases were fatal.
Withhold TAGRISSO and promptly investigate for ILD in patients who
present with worsening of respiratory symptoms which may be
indicative of ILD (eg, dyspnea, cough and fever). Permanently
discontinue TAGRISSO if ILD is confirmed
- Heart rate-corrected QT (QTc) interval prolongation occurs in
TAGRISSO-treated patients. Of the 1479 TAGRISSO-treated patients in
clinical trials, 0.8% were found to have a QTc >500 msec, and
3.1% of patients had an increase from baseline QTc >60 msec. No
QTc-related arrhythmias were reported. Conduct periodic monitoring
with ECGs and electrolytes in patients with congenital long QTc
syndrome, congestive heart failure, electrolyte abnormalities, or
those who are taking medications known to prolong the QTc interval.
Permanently discontinue TAGRISSO in patients who develop QTc
interval prolongation with signs/symptoms of life-threatening
arrhythmia
- Cardiomyopathy occurred in 3% of the 1479 TAGRISSO-treated
patients; 0.1% of cardiomyopathy cases were fatal. A decline in
left ventricular ejection fraction (LVEF) ≥10% from baseline and to
<50% LVEF occurred in 3.2% of 1233 patients who had baseline and
at least one follow-up LVEF assessment. In the ADAURA study, 1.5%
(5/325) of TAGRISSO-treated patients experienced LVEF decreases
≥10% from baseline and a drop to <50%. Conduct cardiac
monitoring, including assessment of LVEF at baseline and during
treatment, in patients with cardiac risk factors. Assess LVEF in
patients who develop relevant cardiac signs or symptoms during
treatment. For symptomatic congestive heart failure, permanently
discontinue TAGRISSO
- Keratitis was reported in 0.7% of 1479 patients treated with
TAGRISSO in clinical trials. Promptly refer patients with signs and
symptoms suggestive of keratitis (such as eye inflammation,
lacrimation, light sensitivity, blurred vision, eye pain and/or red
eye) to an ophthalmologist
- Postmarketing cases consistent with Stevens-Johnson syndrome
(SJS) and erythema multiforme major (EMM) have been reported in
patients receiving TAGRISSO. Withhold TAGRISSO if SJS or EMM is
suspected and permanently discontinue if confirmed
- Postmarketing cases of cutaneous vasculitis including
leukocytoclastic vasculitis, urticarial vasculitis, and IgA
vasculitis have been reported in patients receiving TAGRISSO.
Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate
for systemic involvement, and consider dermatology consultation. If
no other etiology can be identified, consider permanent
discontinuation of TAGRISSO based on severity
- Aplastic anemia has been reported in patients treated with
TAGRISSO in clinical trials (0.07% of 1479) and post marketing.
Some cases had a fatal outcome. Inform patients of the signs and
symptoms of aplastic anemia including but not limited to, new or
persistent fevers, bruising, bleeding, and pallor. If aplastic
anemia is suspected, withhold TAGRISSO and obtain a hematology
consultation. If aplastic anemia is confirmed, permanently
discontinue TAGRISSO. Perform complete blood count with
differential before starting TAGRISSO, periodically throughout
treatment, and more frequently if indicated
- Verify pregnancy status of females of reproductive potential
prior to initiating TAGRISSO. Advise pregnant women of the
potential risk to a fetus. Advise females of reproductive potential
to use effective contraception during treatment with TAGRISSO and
for 6 weeks after the final dose. Advise males with female partners
of reproductive potential to use effective contraception for 4
months after the final dose
- Most common (≥20%) adverse reactions, including laboratory
abnormalities, were leukopenia, lymphopenia, thrombocytopenia,
diarrhea, anemia, rash, musculoskeletal pain, nail toxicity,
neutropenia, dry skin, stomatitis, fatigue, and cough
INDICATIONS
- TAGRISSO is indicated as adjuvant therapy after tumor resection
in adult patients with non-small cell lung cancer (NSCLC) whose
tumors have epidermal growth factor receptor (EGFR) exon 19
deletions or exon 21 L858R mutations, as detected by an
FDA-approved test
- TAGRISSO is indicated for the first-line treatment of adult
patients with metastatic non-small cell lung cancer (NSCLC) whose
tumors have epidermal growth factor receptor (EGFR) exon 19
deletions or exon 21 L858R mutations, as detected by an
FDA-approved test
- TAGRISSO is indicated for the treatment of adult patients with
metastatic EGFR T790M mutation-positive NSCLC, as detected by an
FDA-approved test, whose disease has progressed on or after EGFR
tyrosine kinase inhibitor (TKI) therapy
Please see complete Prescription Information, including Patient
Information for TAGRISSO.
You may report side effects related to AstraZeneca products by
clicking here.
Notes
Lung cancer
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
advanced disease.7
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 tumor
cells.8
FLAURA2
FLAURA2 is a randomized, open-label, multi-center, 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
weeks.
The trial was enrolled in more than 150 centers 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
of OS.
TAGRISSO®
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 tumor 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
tremelimumab and gefitinib; durvalumab and tremelimumab;
fam-trastuzumab deruxtecan-nxki and datopotamab deruxtecan in
collaboration with Daiichi Sankyo; 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
beyond treatment.
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 catalyze 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.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development, and commercialization
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. For more
information, please visit www.astrazeneca-us.com and follow us on
Twitter @AstraZenecaUS.
References
- World Health Organization. International Agency for Research on
Cancer. Lung Fact Sheet. Available at:
https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed May 2023.
- LUNGevity Foundation. Types of Lung Cancer. Available at:
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed May 2023.
- 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.
- 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.
- 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.
- Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a
Review of Available Methods and Their Use for Analysis of Tumor
Tissue and Cytology Samples. J Clin Pathol. 2013:66;79-89.
- Cagle P, et al. Lung Cancer Biomarkers: Present Status and
Future Developments. Archives Pathology Lab Med.
2013;137:1191-1198.
- Cross DA, et al. AZD9291, an Irreversible EGFR TKI, Overcomes
T790M-Mediated Resistance to EGFR Inhibitors in Lung Cancer. Cancer
Discov. 2014;4(9):1046-1061
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Media Inquiries Brendan McEvoy, +1 302 885 2677 Chelsea
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