REG - AstraZeneca PLC - Tagrisso improved PFS in Stage III lung cancer

AstraZenecaAnnouncement

19/02/2024 07:00

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RNS Number : 5213D  AstraZeneca PLC  19 February 2024

19 February 2024

 

Tagrisso demonstrated overwhelming efficacy benefit for patients with
unresectable, Stage III EGFR-mutated lung cancer in LAURA Phase III trial

First EGFR inhibitor and targeted treatment to demonstrate

progression-free survival benefit in Stage III setting

Positive high-level results from the LAURA Phase III trial showed
AstraZeneca's Tagrisso (osimertinib) demonstrated a statistically significant
and highly clinically meaningful improvement in progression-free survival
(PFS) for patients with unresectable, Stage III epidermal growth factor
receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after
chemoradiotherapy (CRT) compared to placebo after CRT.

 

Overall survival (OS) data showed a favourable trend for Tagrisso, although
data were not mature at the time of this analysis. The trial will continue to
assess OS as a secondary endpoint.

 

Each year an estimated 2.4 million people are diagnosed with lung cancer
globally with 80-85% of patients diagnosed with NSCLC, the most common form of
lung cancer.(1-3) Approximately 10-15% of NSCLC patients in the US and Europe,
and 30-40% of patients in Asia, have EGFR mutations.(4-7) More than one in
six patients with NSCLC are diagnosed with unresectable Stage III disease
(15%).(8)

 

Suresh Ramalingam, MD, Executive Director of Winship Cancer Institute of Emory
University, Atlanta, US, and principal investigator in the trial, said: "These
results represent a major advance for patients with Stage III EGFR-mutated
lung cancer who have a high propensity for early progression and spread to the
brain, and where no targeted therapy is available. LAURA shows osimertinib can
provide impactful clinical benefit and could become the first targeted
treatment option for patients with Stage III disease."

 

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca,
said: "These highly impactful results for the LAURA trial in this potentially
curative early lung cancer setting further entrench Tagrisso as the backbone
therapy for EGFR-mutated lung cancer. These data together with the ADAURA
data, reinforce the imperative to diagnose and treat patients with lung cancer
as early as possible."

 

The safety and tolerability of Tagrisso in the LAURA trial was consistent with
its established profile and no new safety concerns were reported with Tagrisso
maintenance treatment following CRT.

 

The data will be presented at a forthcoming medical meeting and shared with
global regulatory authorities.

 

In addition, Tagrisso plus chemotherapy was recently approved in the US based
on the FLAURA2 Phase III trial.

 

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 with results expected
later this year, and in the early-stage adjuvant resectable setting in the
ADAURA2 Phase III trial.

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.(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.(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 permitted to be treated
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. This is the
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 central nervous system
metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to
treat more than 800,000 patients across its indications worldwide and
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.

 

There is an extensive body of evidence supporting the use of Tagrisso in EGFRm
NSCLC. Tagrisso is the only targeted therapy to improve patient outcomes in
both 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)
and 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 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)
.

 

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, 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 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 operates in over 100 countries
and its innovative medicines are 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.
For Media contacts, click here
(https://www.astrazeneca.com/media-centre/contacts.html) .

 

References

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

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

3.   American Cancer Society. What Is Lung Cancer? Available at:
https://www.cancer.org/cancer/lung-cancer/about/what-is.html#:~:text=About%2080%25%20to%2085%25%20of,(outlook)%20are%20often%20similar
(https://www.cancer.org/cancer/lung-cancer/about/what-is.html#:~:text=About%2080%25%20to%2085%25%20of,(outlook)%20are%20often%20similar)
. Accessed February 2024.  

4.   Knight SB, et al. Progress and prospects of early detection in lung
cancer. Open Biol. 2017;7(9): 170070.

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.   Zhang Y, et al. The prevalence of EGFR mutation in patients with
non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget.
2016;7(48).

7.   Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological
and Histological Samples in 11. 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. 

8.   Cerner CancerMPact database.Accessed October 2023.

9.   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.

10.  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.

11.  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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