REG - AstraZeneca PLC - Tagrisso recommended for EU approval - LAURA

AstraZenecaAnnouncement

18/11/2024 07:00

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RNS Number : 5095M  AstraZeneca PLC  18 November 2024

18 November 2024

 

Tagrisso recommended for approval in the EU by CHMP

for patients with unresectable EGFR-mutated lung cancer

 

 Recommendation 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 recommended for approval 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 Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) based its positive opinion on the 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/) .

 

Results showed Tagrisso reduced the risk of disease progression or death by
84% compared to placebo (hazard ratio  HR  0.16; 95% confidence interval  CI 
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 at this current analysis. The
trial continues to assess OS as a secondary endpoint.

 

Each year in Europe, there are more than 450,000 people diagnosed with lung
cancer.(1) Among those with NSCLC, the most common form of lung cancer, about
10-15% of patients in Europe have tumours with an EGFR mutation.(2,3)
Additionally, nearly one in five people with NSCLC has an unresectable
tumour.(4)

 

Manuel Cobo, MD, Specialist Physician of the Medical Oncology Service at the
Carlos Haya University Hospital, Malaga, Spain, and investigator for the
trial, said: "The LAURA results build on the established efficacy of
osimertinib and support the approval of the first targeted therapy for
patients with unresectable, EGFR-mutated lung cancer. Today's positive
recommendation marks an important step towards offering patients in Europe a
targeted treatment option that can extend the time before their disease
progresses by more than three years."

 

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca,
said: "Today's news reinforces Tagrisso as the backbone therapy in
EGFR-mutated non-small cell lung cancer, meeting the critical unmet need for
an effective targeted treatment option in the unresectable setting. Tagrisso
has now demonstrated its benefit across all stages of EGFR-mutated lung
cancer, representing a pivotal step in transforming care for patients who are
urgently in need of innovative therapies that can help extend their lives."
 

 

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

 

Tagrisso following CRT was recently approved for the treatment of adult
patients with unresectable, Stage III EGFRm NSCLC in the US. Regulatory
applications are also currently under review in China, Japan and several other
countries based on the LAURA trial.

 

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.(5) 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.(3) The majority of all
NSCLC patients are diagnosed with advanced disease.(6)

 

Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of
patients in Asia have EGFRm NSCLC.(7-9) 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.(10)

 

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
(CNS) 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.   Sanden SV, et al. Prevalence of Epidermal Growth Factor Receptor Exon
20 Insertion Mutations in Non-small-Cell Lung Cancer in Europe: A Pragmatic
Literature Review and Meta-analysis. Targeted Onc. 2022;17:153-166.

3.   LUNGevity Foundation. Types of Lung Cancer. Available at:
https://www.lungevity.org/lung-cancer-basics/types-of-lung-cancer. Accessed
November 2024.

4.   Quint LE. Lung cancer: assessing resectability. Cancer Imaging.
2004;4(1):15-18.

5.   World Health Organization. International Agency for Research on Cancer.
All Cancers Fact Sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf.
Accessed November 2024.

6.   Cagle P, et al. Lung Cancer Biomarkers: Present Status and Future
Developments. Arch Pathol Lab Med. 2013;137(9):1191-1198. 

7.   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(15):2121-2127.

8.   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(12): 2800-2812. 

9.   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(2):79-89. 

10.  Cross DAE, 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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