TIDMAZN
RNS Number : 3760R
AstraZeneca PLC
28 October 2019
This announcement contains inside information
28 October 2019 15:15 GMT
Imfinzi and Imfinzi plus tremelimumab delayed disease
progression in Phase III POSEIDON trial for 1st-line treatment of
Stage IV non-small cell lung cancer
POSEIDON included both non-squamous and squamous
patients and a broad choice of standard chemotherapy options
AstraZeneca today announced positive progression-free survival
(PFS) results for Imfinzi (durvalumab) and tremelimumab, an
anti-CTLA4 antibody, when added to chemotherapy, from the Phase III
POSEIDON trial in previously-untreated Stage IV (metastatic)
non-small cell lung cancer (NSCLC).
The trial met a primary endpoint by showing a statistically
significant and clinically meaningful improvement in the final PFS
analysis in patients treated with the combination of Imfinzi and a
broad choice of five standard-of-care platinum-based chemotherapy
options vs. chemotherapy alone. The triple combination of Imfinzi
plus tremelimumab and chemotherapy also demonstrated a
statistically significant and clinically meaningful PFS improvement
vs. chemotherapy alone as a key secondary endpoint. The safety and
tolerability of Imfinzi was consistent with its known safety
profile. The triple combination delivered a broadly similar safety
profile to the Imfinzi and chemotherapy combination and did not
result in increased discontinuation of therapy.
Jose Baselga, Executive Vice President, Oncology R&D, said:
"The POSEIDON trial provides evidence of the efficacy of Imfinzi in
patients with Stage IV non-small cell lung cancer. Clinical benefit
was observed in a trial population that included a high proportion
of patients with squamous disease and multiple choices of
chemotherapy regimens. Additionally, the potential to add
tremelimumab to Imfinzi and chemotherapy may present an important
treatment approach in this challenging setting, especially taking
into consideration the favourable safety profile."
The POSEIDON trial will continue to assess the additional
primary endpoint of overall survival (OS) with data anticipated in
2020. AstraZeneca will submit the results for presentation at a
forthcoming medical meeting and plans to share the results with
health authorities.
Imfinzi is also being tested in Stage IV NSCLC as monotherapy in
the Phase III PEARL trial, and in earlier stages of disease as part
of an extensive Immuno-Oncology programme in lung cancer.
Imfinzi is approved in the curative-intent setting of
unresectable, Stage III NSCLC after chemoradiation therapy in 53
countries, including the US, Japan and across the EU, based on the
Phase III PACIFIC trial.
About POSEIDON
The POSEIDON trial is a randomised, open-label, multi-centre,
global, Phase III trial of Imfinzi plus platinum-based chemotherapy
or Imfinzi, tremelimumab and chemotherapy vs. chemotherapy alone in
the 1st-line treatment of patients with metastatic NSCLC. The trial
population included patients with either non-squamous or squamous
disease and the full range of PD-L1 expression levels. POSEIDON
excluded patients with a mutation in the epidermal growth factor
receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene. In the
experimental arms, patients were treated with a flat dose of
1,500mg of Imfinzi with four cycles of chemotherapy once every
three weeks or Imfinzi plus 75mg of tremelimumab, followed by
maintenance therapy with Imfinzi or Imfinzi and one dose of
tremelimumab on a once-every-four-weeks dosing schedule. In
comparison, the control arm allowed up to six cycles of
chemotherapy. Pemetrexed maintenance therapy was allowed in all
arms in patients with non-squamous disease if given during the
induction phase.
The trial is being conducted in 153 centres across 18 countries,
including the US, Europe, South America, Asia and South Africa.
Primary endpoints include PFS and OS for the Imfinzi plus
chemotherapy arm. Key secondary endpoints include PFS and OS in the
Imfinzi plus tremelimumab and chemotherapy arm.
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.(1)
Lung cancer is broadly split into NSCLC and SCLC, with 80-85%
classified as NSCLC.(2) Within NSCLC, patients are classified as
squamous, representing 25-30% of patients, or non-squamous, the
most common type representing approximately 70-75% of NSCLC
patients.(2) Stage IV is the most advanced form of lung cancer and
is often referred to as metastatic disease.(3) Lung cancer patients
are most commonly diagnosed after the tumour has spread outside of
the lung.(4) For these patients with metastatic disease, prognosis
is particularly poor, as only 1 in 10 will be alive five years
after diagnosis.(5)
About Imfinzi
Imfinzi 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 53
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 11
countries, including the US.
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, bladder
cancer, head and neck cancer, liver cancer, biliary tract cancer,
cervical 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, and FLAURA2 as well as the
Phase II combination trials SAVANNAH and ORCHARD.(6-8)
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.(9) Imfinzi, an anti-PDL1 antibody, is in development for
patients with advanced disease (Phase III trials POSEIDON, PEARL,
and CASPIAN) and for patients in earlier stages of disease
including potentially-curative settings (Phase III trials AEGEAN,
ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) 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, Cardiovascular, Renal and
Metabolism, and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and follow the
Company on Twitter @AstraZeneca.
Media Relations
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References
1. World Health Organization. International Agency for Research
on Cancer. Available at
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed
October 2019.
2. Abernethy AP, et al. Real-world first-line treatment and
overall survival in non-small cell lung cancer without known EGFR
mutations or ALK rearrangements in US community oncology setting.
PLoS ONE. 2017;12(6): e0178420.
https://doi.org/10.1371/journal.pone.0178420
3. Cancer.Net. Lung Cancer - Non-Small Cell: Stages. Available
at
https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/stages.
Accessed October 2019.
4. Ridge C, et al. Epidemiology of Lung Cancer. Semin Intervent
Radiol. 2013;30:93-98.
5. Cancer.Net. Lung Cancer - Non-Small Cell - Statistics."
Available at
www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.
Accessed October 2019.
6. 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.
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;2121-27.
8. 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.
9. Pakkala, S, et al. Personalized therapy for lung cancer:
striking a moving target. JCI Insight. 2018;3(15):e120858.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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