REG - AstraZeneca PLC - Tagrisso approved in EU based on LAURA trial

AstraZenecaAnnouncement

23/12/2024 07:00

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RNS Number : 0214R  AstraZeneca PLC  23 December 2024

 

23 December 2024

 

Tagrisso approved in the EU for patients

with unresectable EGFR-mutated lung cancer

 

 First and only EGFR inhibitor and targeted treatment

approved in the EU in unresectable NSCLC

 

Approval based on LAURA Phase III trial results which showed Tagrisso

extended median progression-free survival to more than three years

 

AstraZeneca's Tagrisso (osimertinib) has been approved in the European Union
(EU) for the treatment of adult patients with locally advanced, unresectable
non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor
receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations
and whose disease has not progressed during or following platinum-based
chemoradiation therapy (CRT).

 

The approval by the European Commission follows the positive opinion
(https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-recommended-for-eu-approval-laura.html)
of the Committee for Medicinal Products for Human Use and is based on results
from the LAURA
(https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-reduced-the-risk-of-disease-progression-or-death-by-84-percent-in-patients-with-unresectable-stage-iii-egfr-mutated-lung-cancer-vs-placebo.html)
Phase III trial, which were published in The New England Journal of Medicine
(https://www.nejm.org/) .

 

In the trial, Tagrisso reduced the risk of disease progression or death by
84% compared to placebo (hazard ratio 0.16; 95% confidence interval
0.10-0.24; p<0.001) as assessed by blinded independent central review.
Median progression-free survival (PFS) was 39.1 months in patients treated
with Tagrisso versus 5.6 months for placebo.

 

Overall survival (OS) results remain immature, and the trial is continuing to
assess OS as a secondary endpoint.

 

Each year in Europe, there are more than 450,000 people diagnosed with lung
cancer, and approximately 80-85% have NSCLC.(1-3) Among those with NSCLC in
Europe, about 10-15% have tumours with an EGFR mutation.(4-6)

Manuel Cobo, MD, Specialist Physician of the Medical Oncology Service at the
Carlos Haya University Hospital, Malaga, Spain, and investigator for the
trial, said: "Today's approval marks a major breakthrough for patients in the
EU with unresectable, EGFR-mutated non-small cell lung cancer, delivering the
first targeted treatment in this setting. Osimertinib reduced the risk of
disease progression or death by an unprecedented 84 per cent in the LAURA
trial, setting a new benchmark for outcomes and underscoring the importance of
testing for EGFR mutations upon diagnosis."

Dave Fredrickson, Executive Vice President, Oncology Business Unit,
AstraZeneca, said: "Tagrisso is now the first and only EGFR inhibitor and
targeted treatment approved in the EU for locally advanced, unresectable lung
cancer, providing a new standard of care to patients who have historically
experienced early progression after chemoradiation therapy. The powerful
results from the LAURA trial show Tagrisso improves outcomes for patients in
the unresectable setting, reinforces the importance of timely EGFR testing and
solidifies Tagrisso as the backbone therapy in EGFR-mutated non-small cell
lung cancer."

 

The safety and tolerability of Tagrisso in the LAURA trial was consistent with
its established profile and no new safety concerns were identified.

 

This is the fifth major approval for Tagrisso based on the LAURA trial
following recent approvals in the US, Switzerland, South Korea and Australia.
Regulatory applications are also currently under review in China, Japan and
several other countries.

 

Tagrisso is approved as monotherapy in more than 100 countries including in
the US, EU, China and Japan. Approved indications include 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 EGFRm NSCLC. Tagrisso is also approved in combination with
chemotherapy in the US, China and several other countries for 1st-line
treatment of patients with locally advanced or metastatic EGFRm NSCLC.

 

Notes

 

Lung cancer

Each year, an estimated 2.4 million people are diagnosed with lung cancer
globally.(7) Lung cancer is the leading cause of cancer death among both men
and women, accounting for about one-fifth of all cancer deaths.(7) Lung cancer
is broadly split into NSCLC and small cell lung cancer, with 80-85% of
patients diagnosed with NSCLC, the most common form of lung cancer.(2,3) The
majority of all NSCLC patients are diagnosed with advanced disease.(8)

 

Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of
patients in Asia have EGFRm NSCLC.(4-6) Patients with EGFRm NSCLC are
particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor
(EGFR-TKI) which blocks the cell-signalling pathways that drive the growth of
tumour cells.(9)

 

LAURA

LAURA is a randomised, double-blind, placebo-controlled, multi-centre, global
Phase III trial in patients with unresectable, Stage III EGFRm NSCLC whose
disease has not progressed following definitive platinum‑based CRT. Patients
were treated with Tagrisso 80mg once-daily oral tablets until disease
progression, unacceptable toxicity or other discontinuation criteria were met.
Upon progression, patients in the placebo arm were offered treatment with
Tagrisso.

 

The trial enrolled 216 patients in more than 145 centres across more than 15
countries, including in the US, Europe, South America and Asia. The primary
endpoint is 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 central nervous system
metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to
treat patients across its indications worldwide and AstraZeneca continues to
explore Tagrisso as a treatment for patients across multiple stages of EGFRm
NSCLC.

 

There is an extensive body of evidence supporting the use of Tagrisso as
standard of care in EGFRm NSCLC. Tagrisso improved patient outcomes in
early-stage disease in the ADAURA Phase III trial
(https://www.astrazeneca.com/media-centre/press-releases/2023/tagrisso-demonstrated-strong-overall-survival-benefit-in-the-adaura-phase-iii-trial.html)
, Stage III, unresectable disease in the LAURA Phase III trial
(https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-improved-pfs-in-stage-iii-lung-cancer.html)
, late-stage disease in the FLAURA Phase III trial
(https://www.astrazeneca.com/media-centre/press-releases/2019/tagrisso-significantly-improves-overall-survival-in-the-phase-iii-flaura-trial-for-1st-line-egfr-mutated-non-small-cell-lung-cancer-09082019.html)
, and with chemotherapy in the FLAURA2 Phase III trial
(https://www.astrazeneca.com/media-centre/press-releases/2023/tagrisso-plus-chemotherapy-extended-median-progression-free-survival-by-nearly-9-months-in-egfr-mutated-advanced-lung-cancer-in-flaura2-phase-iii-trial.html)
.

 

As part of AstraZeneca's ongoing commitment to treating patients as early as
possible in lung cancer, Tagrisso is also being investigated in the
neoadjuvant setting in the NeoADAURA Phase III trial and in the early-stage
adjuvant resectable setting in the ADAURA2 Phase III trial.

 

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 plus savolitinib 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 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 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 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

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's innovative medicines are
sold in more than 125 countries and used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the
Company on social media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca) .

 

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.   Ferlay J, et al. Cancer incidence and mortality patterns in Europe:
Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer.
2018;103:356-387.

2.   American Cancer Society. What Is Lung Cancer? Available at:
https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed
December 2024.

3.   LUNGevity Foundation. Types of Lung Cancer. Available at:
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed December 2024.

4.   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;29:2121-2127.

5.   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;6:2800-2812.

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.   World Health Organization. International Agency for Research on Cancer.
Lung Cancer Fact Sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf.
Accessed December 2024.

8.   González M, et al. Overall survival for early and locally advanced
non-small-cell lung cancer from one institution: 2000-2017. Clin Transl Oncol.
2021;23(7):1325-1333.

9.   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.

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

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