TIDMAZN
RNS Number : 3073F
AstraZeneca PLC
12 July 2019
12 July 2019 07:00 BST
Imfinzi granted US Orphan Drug Designation for small cell lung
cancer
AstraZeneca today announced that the US Food and Drug
Administration (FDA) has granted Orphan Drug Designation (ODD) to
Imfinzi (durvalumab) for the treatment of small cell lung cancer
(SCLC).
SCLC constitutes about 15% of all lung cancer diagnoses. It is
the most aggressive type of lung cancer with only 6% of patients
alive after five years. The FDA grants ODD status to medicines and
potential new medicines intended for the treatment, diagnosis or
prevention of rare diseases or disorders that affect fewer than
200,000 people in the US.
In June 2019, the Phase III CASPIAN trial met its primary
endpoint with Imfinzi by showing a statistically-significant and
clinically-meaningful improvement in overall survival for patients
with extensive-stage SCLC. These patients were treated with Imfinzi
in combination with standard-of-care etoposide and platinum-based
chemotherapy vs. chemotherapy alone. Results will be shared at a
forthcoming medical meeting. Imfinzi is also being tested following
concurrent chemoradiation therapy in limited-stage SCLC in the
Phase III ADRIATIC trial.
José Baselga, Executive Vice President, R&D Oncology said:
"This Orphan Drug Designation comes on the heels of positive
results from the Phase III CASPIAN trial, which is the first trial
to offer the flexibility of combining immunotherapy with different
platinum-based regimens in small cell lung cancer. We are eager to
expand treatment options for patients facing such a devastating
diagnosis and look forward to working with regulatory authorities
to bring forward new options as soon as possible."
Imfinzi is currently approved for unresectable, Stage III
non-small cell lung cancer (NSCLC) after chemotherapy and radiation
therapy in more than 45 countries including the US, EU, and Japan
based on the Phase III PACIFIC trial.
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.(1)
Lung cancer is broadly split into NSCLC and SCLC, with about 15%
classified as SCLC.(2) About two-thirds 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.(3)
SCLC is an aggressive, fast-growing cancer that recurs and
progresses rapidly despite initial response to platinum-based
chemotherapy.(4) Prognosis is particularly poor, as only 6% of all
SCLC patients will be alive five years after diagnosis.(3)
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 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 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 and lines of therapy. 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 FLAURA, ADAURA and LAURA as well as the Phase II exploratory
combination trials SAVANNAH and ORCHARD.(5-7)
Our extensive late-stage Immuno-Oncology programme focuses on
lung cancer patients without a known genetic mutation which
represents up to 50% of all patients with lung cancer. Imfinzi
(durvalumab), an anti-PDL1 antibody is in development as
monotherapy (Phase III trials ADJUVANT BR.31, PACIFIC-4, PACIFIC-5,
and PEARL) and in combination with tremelimumab and/or chemotherapy
(AEGEAN, PACIFIC-2, NEPTUNE, POSEIDON, ADRIATIC and CASPIAN Phase
III trials).
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 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, we
are committed to advance Oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to our core capabilities, we actively pursue innovative
partnerships and investments that accelerate the delivery of our
strategy as illustrated by our 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 &
Metabolism 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 BioPharma +44 203 749 5906
Jennifer Hursit Other +44 203 749 5762
Christina Malmberg H gerstrand 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 BioPharma (cardiovascular; metabolism) +44 203 749 5711
Nick Stone BioPharma (respiratory; renal) +44 203 749 5716
Josie Afolabi Other medicines +44 203 749 5631
Craig Marks Finance; fixed oncome +44 7881 615 764
Jennifer Kretzmann Corporate access; retail investors +44 203 749 5824
US toll-free +1 866 381 7277
Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. World Health Organization. International Agency for Research
on Cancer. Available at
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed
May 2019.
2. LUNGevity Foundation. Types of Lung Cancer. Available at
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed May 2019.
3. Cancer.Net. Lung Cancer - Small Cell. Available at
https://www.cancer.net/cancer-types/33776/view-all. Accessed May
2019.
4. 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.
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. Accessed
May 2019.
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. Accessed May 2019.
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. Accessed
May 2019.
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