TIDMAZN
RNS Number : 7014J
AstraZeneca PLC
21 August 2019
21 August 2019 07:00 BST
Update on the Phase III NEPTUNE trial of Imfinzi plus
tremelimumab in Stage IV non-small cell lung cancer
AstraZeneca today announced final overall survival (OS) results
from the Phase III NEPTUNE trial, a randomised, open-label,
multi-centre, global trial of Imfinzi (durvalumab) in combination
with tremelimumab, an anti-CTLA4 antibody, vs. standard-of-care
(SoC) platinum-based chemotherapy in previously-untreated Stage IV
(metastatic) non-small cell lung cancer (NSCLC) patients. The trial
was performed in an all-comers population, and the primary analysis
population was patients with a high tumour mutational burden (TMB).
TMB is a measurement of the number of mutations within the genome
(DNA) of a tumour, and tumours with high levels of TMB may be more
visible to the immune system.(1,2)
In the primary analysis population of patients whose blood TMB
was 20 or more mutations per megabase (mut/Mb), the combination of
Imfinzi and tremelimumab did not meet the primary endpoint of
improving OS compared to SoC chemotherapy. The safety and
tolerability profile for the combination of Imfinzi and
tremelimumab was consistent with previous trials.
José Baselga, Executive Vice President, Oncology R&D said:
"We are fully committed to a deep analysis of the vast clinical and
biomarker data from this trial to gain further insights to improve
Immuno-Oncology approaches for patients with metastatic non-small
cell lung cancer."
AstraZeneca will submit the full results for presentation at a
forthcoming medical meeting.
Imfinzi is also being tested as monotherapy in the Phase III
PEARL trial, and in combination with chemotherapy with or without
tremelimumab in the Phase III POSEIDON trial as part of an
extensive late-stage Immuno-Oncology programme in Stage IV
NSCLC.
About NEPTUNE
The NEPTUNE trial is a randomised, open-label, multi-centre,
global, Phase III trial of Imfinzi in combination with tremelimumab
vs. SoC platinum-based chemotherapy in the 1st-line treatment of
patients with Stage IV (metastatic) NSCLC. The trial population
included patients with non-squamous or squamous histologies, no
epidermal growth factor receptor (EGFR) or anaplastic lymphoma
kinase (ALK) mutation and the full range of PD-L1 expression
levels. The primary endpoint was OS in patients with high blood TMB
defined as >= 20 mut/Mb.
The trial is being conducted in more than 200 centres across 29
countries, including the US, Europe, South and Central America, the
Middle East and Asia.
About Stage IV NSCLC
Lung cancer is the leading cause of cancer death among both men
and women and accounts for about one-fifth of all cancer deaths.(3)
Lung cancer is broadly split into NSCLC and SCLC, with 80-85%
classified as NSCLC.(4) Stage IV is the most advanced form of lung
cancer and is often referred to as metastatic disease.(5) Lung
cancer patients are most commonly diagnosed after the tumour has
spread outside of the lung.(6) For these patients with metastatic
disease, prognosis is particularly poor, as only 1 in 10 will be
alive five years after diagnosis.(7)
About Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds
to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80,
countering the tumour's immune-evading tactics and releasing the
inhibition of immune responses.
Imfinzi is approved for unresectable, Stage III NSCLC in 49
countries including the US, Japan, and across the EU, based on the
Phase III PACIFIC trial. Imfinzi is also approved for
previously-treated patients with advanced bladder cancer in the US,
Canada, Brazil, Australia, Israel, India, United Arab Emirates,
Qatar, Macau and Hong Kong.
As part of a broad development programme, Imfinzi is also being
tested as a monotherapy and in combination with tremelimumab, an
anti-CTLA4 monoclonal antibody and potential new medicine, as a
treatment for patients with NSCLC, small-cell lung cancer (SCLC),
bladder cancer, head and neck cancer, liver cancer, cervical
cancer, biliary tract cancer and other solid tumours.
About tremelimumab
Tremelimumab is a human monoclonal antibody and potential new
medicine that targets the activity of cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the
activity of CTLA-4, contributing to T cell activation and boosting
the immune response to cancer. Tremelimumab is being tested in a
clinical trial programme in combination with Imfinzi in NSCLC,
bladder cancer, head and neck cancer, liver cancer and blood
cancers.
About AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and
potential new medicines in late-stage clinical development for the
treatment of different forms of lung cancer spanning several stages
of disease, lines of therapy and modes of action. We aim to address
the unmet needs of patients with EGFR-mutated tumours as a genetic
driver of disease, which occur in 10-15% of NSCLC patients in the
US and EU and 30-40% of NSCLC patients in Asia, with our approved
medicines Iressa (gefitinib) and Tagrisso (osimertinib), and
ongoing Phase III trials ADAURA, LAURA, FLAURA and FLAURA2 as well
as the Phase II combination trials SAVANNAH and ORCHARD.(8-10)
Our extensive late-stage Immuno-Oncology programme focuses on
lung cancer patients without a targetable genetic mutation which
represents approximately three-quarters of all patients with lung
cancer.(11) Imfinzi (durvalumab), an anti-PDL1 antibody, is in
development for patients with advanced disease (Phase III trials
NEPTUNE, POSEIDON, PEARL, and CASPIAN) and for patients in earlier
stages of disease including potentially-curative settings (Phase
III trials AEGEAN, PACIFIC-2, ADRIATIC, ADJUVANT BR.31, PACIFIC-4,
and PACIFIC-5) both as monotherapy and in combination with
tremelimumab and/or chemotherapy.
About AstraZeneca's approach to Immuno-Oncology (IO)
IO is a therapeutic approach designed to stimulate the body's
immune system to attack tumours. Our IO portfolio is anchored by
immunotherapies that have been designed to overcome anti-tumour
immune suppression. We believe that IO-based therapies offer the
potential for life-changing cancer treatments for the clear
majority of patients.
We are pursuing a comprehensive clinical-trial programme that
includes Imfinzi (anti-PDL1) as monotherapy and in combination with
tremelimumab (anti-CTLA4) in multiple tumour types, stages of
disease, and lines of therapy, using the PD-L1 biomarker as a
decision-making tool to define the best potential treatment path
for a patient. In addition, the ability to combine our IO portfolio
with radiation, chemotherapy, small targeted molecules from across
our Oncology pipeline, and from our research partners, may provide
new treatment options across a broad range of tumours.
About 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 at
least six new medicines to be 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. In
addition to AstraZeneca's main capabilities, the Company is
actively pursuing innovative partnerships and investments that
accelerate the delivery of our strategy, as illustrated by the
investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and, one day, eliminate cancer as a cause
of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, CVRM and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit astrazeneca.com and follow us on Twitter
@AstraZeneca.
Media Relations
Gonzalo Viña +44 203 749 5916
Rob Skelding Oncology +44 203 749 5821
Rebecca Einhorn Oncology +1 301 518 4122
Matt Kent BioPharmaceuticals +44 203 749 5906
Jennifer Hursit Other +44 203 749 5762
Christina Malmberg Hägerstrand Sweden +46 8 552 53 106
Michele Meixell US +1 302 885 2677
Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Henry Wheeler Oncology +44 203 749 5797
Christer Gruvris BioPharmaceuticals (cardiovascular, metabolism) +44 203 749 5711
Nick Stone BioPharmaceuticals (respiratory, renal) +44 203 749 5716
Josie Afolabi Other medicines +44 203 749 5631
Craig Marks Finance, fixed income +44 7881 615 764
Jennifer Kretzmann Corporate access, retail investors +44 203 749 5824
US toll-free +1 866 381 72 77
Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. ESMO. "Tumour Mutational Load: ESMO Biomarker Factsheet."
Available at:
http://oncologypro.esmo.org/Education-Library/Factsheets-on-Biomarkers/Tumour-Mutational-Load
Date Accessed: August 2019.
2. Huang A, et al. T-cell invigoration to tumour burden ratio
associated with anti-PD-1 response. Nature. 2017;454:60-65.
3. World Health Organization. International Agency for Research
on Cancer. Available at
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed
August 2019.
4. LUNGevity Foundation. Types of Lung Cancer. Available at
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed August 2019.
5. Cancer.Net. Lung Cancer - Non-Small Cell: Stages. Available
at
https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/stages.
Accessed August 2019.
6. Ridge C, et al. Epidemiology of Lung Cancer. Semin Intervent
Radiol. 2013;30:93-98.
7. Cancer.Net. Lung Cancer - Non-Small Cell - Statistics."
Available at
www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
Accessed August 2019.
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;2800-12.
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. Pakkala, S, et al. Personalized therapy for lung cancer:
striking a moving target. JCI Insight. 2018;3(15):e120858.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
RESCKKDNKBKBPFB
(END) Dow Jones Newswires
August 21, 2019 02:00 ET (06:00 GMT)
Grafico Azioni Astrazeneca (LSE:AZN)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Astrazeneca (LSE:AZN)
Storico
Da Apr 2023 a Apr 2024