Unprecedented results show treatment with
TAGRISSO reduced the risk of disease recurrence or death by 80% in
ADAURA Phase III trial
AstraZeneca’s TAGRISSO® (osimertinib) has received acceptance
for its supplemental New Drug Application (sNDA) and has also been
granted Priority Review in the US for the adjuvant treatment of
patients with early-stage (IB, II and IIIA) epidermal growth factor
receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after
complete tumor resection with curative intent.
While up to 30% of all patients with NSCLC may be diagnosed
early enough to have potentially curative surgery, disease
recurrence is still common in early-stage disease and nearly half
of patients diagnosed in Stage IB, and over three quarters of
patients diagnosed in Stage IIIA, experience recurrence within five
years.1-4
The Food and Drug Administration (FDA) grants Priority Review to
applications for medicines that offer significant improvements over
available options by demonstrating safety or efficacy improvements,
preventing serious conditions, or enhancing patient compliance. The
Prescription Drug User Fee Act date, the FDA action date for their
regulatory decision, is during the first quarter of 2021.
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, said: “Patients with early-stage EGFR-mutated lung cancer are
still at considerable risk of recurrence after surgery and adjuvant
chemotherapy, and new targeted treatment options are critical to
improving outcomes for these patients. This expedited review
underscores the unprecedented disease-free survival benefit
TAGRISSO brings to patients in the adjuvant setting, and we will
continue working with the FDA to provide this practice-changing
treatment to patients as quickly as possible.”
The sNDA was based on results from the ADAURA Phase III trial
showing TAGRISSO demonstrated a statistically significant and
clinically meaningful improvement in disease-free survival (DFS) in
the primary analysis population of patients with Stage II and IIIA
EGFRm NSCLC, and also in the overall trial population of patients
with Stage IB-IIIA disease, a key secondary endpoint.
In April 2020, an Independent Data Monitoring Committee
recommended for the trial to be unblinded two years early, based on
its determination of overwhelming efficacy. Investigators and
patients continue to participate in the trial and remain blinded to
treatment. The results from the ADAURA trial were presented during
the plenary session of the American Society of Clinical Oncology
ASCO20 Virtual Scientific Program in May 2020 and were recently
published in The New England Journal of Medicine.
TAGRISSO received Breakthrough Therapy Designation in this
setting in July 2020. TAGRISSO is approved for both the 1st-line
treatment of patients with metastatic EGFRm NSCLC and for the
treatment of metastatic EGFR T790M mutation-positive NSCLC in the
US, Japan, China, the EU and many other countries around the
world.
SELECT SAFETY INFORMATION
- Interstitial lung disease (ILD)/pneumonitis occurred in
patients treated with TAGRISSO, some of which were fatal. Withhold
TAGRISSO and promptly investigate for ILD in patients who present
with worsening respiratory symptoms. Permanently discontinue if
confirmed
- Monitor patients who have a history or predisposition for QTc
prolongation or those who are taking medications that are 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 TAGRISSO-treated patients, some of
which were fatal. Monitor patients with cardiac risk factors and
assess left ventricular ejection fraction in patients who develop
symptoms during treatment. Permanently discontinue TAGRISSO in
patients with symptomatic congestive heart failure
- Promptly refer patients with signs and symptoms of keratitis to
an ophthalmologist
- Withhold TAGRISSO if Stevens-Johnson syndrome or erythema
multiforme major is suspected and permanently discontinue if
confirmed
- Verify pregnancy status of women prior to use. Advise women to
use effective contraception during treatment with TAGRISSO and for
6 weeks after the final dose. Advise men to use effective
contraception during treatment with TAGRISSO and for 4 months after
the final dose
- Most common adverse reactions (≥20%) were diarrhea, rash, dry
skin, nail toxicity, stomatitis, fatigue, and decreased
appetite
INDICATIONS
- TAGRISSO is indicated for the first-line treatment of 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 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
For additional information, please see the full Prescribing
Information, including Patient Information.
About 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.5 Lung cancer is broadly split into
NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.6
The majority of all NSCLC patients are diagnosed with advanced
disease while approximately 25-30% present with resectable disease
at diagnosis.1-3
For those with resectable tumors, the majority of patients
eventually develop recurrence despite complete tumor resection and
adjuvant chemotherapy.4 Early-stage lung cancer diagnoses are often
only made when the cancer is found on imaging for an unrelated
condition.7-8
Approximately 10-15% of NSCLC patients in the US and Europe, and
30-40% of patients in Asia have EGFRm NSCLC.9-11 These patients are
particularly sensitive to treatment with EGFR-tyrosine kinase
inhibitors (TKIs) which block the cell-signalling pathways that
drive the growth of tumor cells.12
About ADAURA ADAURA is a randomized, double-blinded,
global, placebo-controlled Phase III trial in the adjuvant
treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC
following complete tumor resection and adjuvant chemotherapy as
indicated. Patients were treated with TAGRISSO 80mg once-daily oral
tablets or placebo for three years or until disease recurrence.
The trial enrolled in more than 200 centers across more than 20
countries, including the US, in Europe, South America, Asia and the
Middle East. The primary endpoint is DFS in Stage II and IIIA
patients and a key secondary endpoint is DFS in Stage IB, II and
IIIA patients. The data readout was originally anticipated in 2022.
The trial will continue to assess overall survival.
About TAGRISSO TAGRISSO® (osimertinib) is a
third-generation, irreversible EGFR-TKI with clinical activity
against central nervous system metastases. TAGRISSO 40mg and 80mg
once-daily oral tablets have received approval in the US, Japan,
China, the EU and many countries around the world for 1st-line
EGFRm metastatic NSCLC and EGFR T790M mutation-positive metastatic
NSCLC.
AstraZeneca in lung cancer AstraZeneca has a
comprehensive portfolio of approved and potential new medicines in
late-stage development for the treatment of different forms of lung
cancer spanning different histologies, several stages of disease,
lines of therapy and modes of action.
AstraZeneca aims to address the unmet needs of patients with
EGFRm tumors as a genetic driver of disease with the approved
medicines gefitinib and TAGRISSO and its ongoing LAURA, NeoADAURA
and FLAURA2 Phase III trials.
AstraZeneca is committed to addressing tumor mechanisms of
resistance through the ongoing Phase II trials SAVANNAH and
ORCHARD, which test TAGRISSO in combination with savolitinib, a
selective inhibitor of c-MET receptor tyrosine kinase, along with
other potential new medicines.
AstraZeneca in oncology AstraZeneca has a deep-rooted
heritage in oncology and offers a quickly growing portfolio of new
medicines that has the potential to transform patients' lives and
the Company's future. With seven new medicines launched between
2014 and 2020, and a broad pipeline of small molecules and
biologics in development, the Company is committed to advance
oncology as a key growth driver for AstraZeneca focused on lung,
ovarian, breast and blood cancers.
By harnessing the power of six scientific platforms -
Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response,
Antibody Drug Conjugates, Epigenetics and Cell Therapies - and by
championing the development of personalized combinations,
AstraZeneca has the vision to redefine cancer treatment and one day
eliminate cancer as a cause of death.
AstraZeneca AstraZeneca is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialization of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, Cardiovascular, Renal & Metabolism and Respiratory
& Immunology. AstraZeneca operates in over 100 countries and
its innovative medicines are used by millions of patients
worldwide. For more information, please visit
https://www.astrazeneca-us.com/ and follow us on Twitter
@AstraZenecaUS.
References
1. Cagle P, et al. Lung Cancer Biomarkers: Present Status and
Future Developments. Arch Path Lab Med. 2013;137:1191-1198.
2. Le Chevalier T. Adjuvant Chemotherapy for Resectable
Non-Small-Cell Lung Cancer: Where is it Going? Ann Oncol.
2010;21:196-8.
3. Datta D, et al. Preoperative Evaluation of Patients
Undergoing Lung Resection Surgery. Chest. 2003;123:2096-2103.
4. Pignon et al. Lung Adjuvant Cisplatin Evaluation: A Pooled
Analysis by the LACE Collaborative Group. J Clin Oncol
2008;26:3552-3559.
5. World Health Organization. International Agency for Research
on Cancer. Lung Fact Sheet.
http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed August 2020.
6. LUNGevity Foundation. Types of Lung Cancer.
https://www.lungevity.org/about-lung-cancer/lung-cancer-101/types-of-lung-cancer.
Accessed August 2020.
7. Sethi S, et al. Incidental Nodule Management – Should There
Be a Formal Process?. Jl of Thorac Onc. 2016:8;S494-S497.
8. LUNGevity Foundation. Screening and Early
Detection.https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection#1.
Accessed August 2020.
9. 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.
10. 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.
11. 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.
12. 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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