TIDMAZN
RNS Number : 1178V
AstraZeneca PLC
29 November 2019
29 November 2019 07:00 GMT
Imfinzi granted FDA Priority Review for the treatment
of patients with extensive-stage small cell lung cancer
AstraZeneca today announced that the US Food and Drug
Administration (FDA) has accepted a supplemental Biologics License
Application (sBLA) and granted Priority Review for Imfinzi
(durvalumab) for the treatment of patients with previously
untreated extensive-stage small cell lung cancer (SCLC).
SCLC is an aggressive, fast-growing form of lung cancer that
recurs and progresses rapidly despite initial response to
platinum-based chemotherapy.(1) A Prescription Drug User Fee Act
date is set for the first quarter of 2020.
The sBLA was based on positive results from the Phase III
CASPIAN trial published in The Lancet, showing Imfinzi in
combination with standard-of-care (SoC) chemotherapy (etoposide
with either cisplatin or carboplatin) demonstrated a statistically
significant and clinically meaningful improvement in overall
survival (OS) vs. SoC. The risk of death was reduced by 27% (equal
to a hazard ratio of 0.73), with median OS of 13.0 months for
Imfinzi plus chemotherapy vs. 10.3 months for SoC. Results showed
an estimated 33.9% of patients were alive at 18 months following
treatment with Imfinzi plus chemotherapy vs. 24.7% of patients
receiving SoC.
Imfinzi is approved in the curative-intent setting of
unresectable, Stage III non-small cell lung cancer (NSCLC) after
chemoradiation therapy in 54 countries, including the US, Japan and
the EU, based on the Phase III PACIFIC trial.
About CASPIAN
CASPIAN is a randomised, open-label, multi-centre, global, Phase
III trial in the 1st-line treatment of patients with
extensive-stage SCLC. The trial compared Imfinzi in combination
with etoposide and either cisplatin or carboplatin chemotherapy, or
Imfinzi, tremelimumab and chemotherapy vs. chemotherapy alone. In
the experimental arms, patients were treated with up to four cycles
of chemotherapy. In comparison, the control arm allowed up to six
cycles of chemotherapy and prophylactic cranial irradiation. The
trial will continue to the final analysis of OS for the combination
of Imfinzi, tremelimumab and chemotherapy. The trial is being
conducted in more than 200 centres across 23 countries, including
the US, Europe, South America, Asia and the Middle East. The
primary endpoint is OS.
About small cell lung cancer
Lung cancer is the leading cause of cancer death among both men
and women and accounts for about one-fifth of all cancer deaths.(2)
Lung cancer is broadly split into NSCLC and SCLC, with about 15%
classified as SCLC.(3) About three quarters of SCLC patients are
diagnosed with extensive-stage disease, in which the cancer has
spread widely through the lung or to other parts of the body.
Prognosis is particularly poor, as only 6% of all SCLC patients
will be alive five years after diagnosis.(4)
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 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, SCLC, bladder cancer, head and
neck cancer, liver cancer, biliary tract cancer, cervical cancer
and other solid tumours.
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.(5-7)
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.(8) 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)
Immuno-oncology (IO) is a therapeutic approach designed to
stimulate the body's immune system to attack tumours. The Company's
IO portfolio is anchored by immunotherapies that have been designed
to overcome anti-tumour immune suppression. AstraZeneca believes
that IO-based therapies offer the potential for life-changing
cancer treatments for the majority of patients.
The Company is pursuing a comprehensive clinical-trial programme
that includes Imfinzi as a monotherapy and in combination with
tremelimumab 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 AstraZeneca's
Oncology pipeline, and from 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
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 (CV, Metabolism) +44 203 749 5711
Nick Stone BioPharmaceuticals (Renal), ESG +44 203 749 5716
BioPharmaceuticals (Respiratory),
Josie Afolabi other medicines +44 203 749 5631
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US toll-free +1 866 381 72 77
References
1. Kalemkerian GP, et al. Treatment Options for Relapsed
Small-Cell Lung Cancer: What Progress Have We Made? Journal of
Oncology Practice, volume 14, issue no. 6 (June 1, 2018)
369-370.
2. World Health Organization. International Agency for Research on Cancer. Available at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx Accessed November 2019.
3. LUNGevity Foundation. Types of Lung Cancer. Available at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer Accessed November 2019.
4. Cancer.Net. Lung Cancer - Small Cell. Available at
https://www.cancer.net/cancer-types/33776/view-all Accessed
November 2019.
5. 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.
6. 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.
7. 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.
8. 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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