REG - AstraZeneca PLC - Tagrisso plus chemo improved PFS in lung cancer

AstraZenecaAnnouncement

17/05/2023 07:17

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RNS Number : 6416Z  AstraZeneca PLC  17 May 2023

17 May 2023

 

Tagrisso plus chemotherapy demonstrated strong improvement in progression-free
survival for patients with EGFR-mutated advanced lung cancer in FLAURA2 Phase
III trial

 

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
(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)
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.

 

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 tumour cells.(8)

 

FLAURA2

FLAURA2 is a randomised, open-label, multi-centre, 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 centres 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 tumour 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 Tagrisso (osimertinib) 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 Twitter @AstraZeneca (https://twitter.com/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.   World Health Organisation. 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.

2.   LUNGevity Foundation. Types of Lung Cancer. Available at:
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed May 2023.

3.   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.

4.   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.

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.   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.   Cagle P, et al. Lung Cancer Biomarkers: Present Status and Future
Developments. Archives Pathology Lab Med. 2013;137:1191-1198.

8.   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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