TIDMAZN
RNS Number : 8327L
AstraZeneca PLC
15 January 2021
15 January 2021 07:00 GMT
Imfinzi approved in the EU for less-frequent, fixed-
dose use in unresectable non-small cell lung cancer
New option extends dosing from two to four weeks,
reducing medical visits and improving patient convenience
AstraZeneca's Imfinzi (durvalumab) has been approved in the
European Union and the UK for an additional dosing option, a
1,500mg fixed dose every four weeks, in locally advanced,
unresectable non-small cell lung cancer (NSCLC) in adults whose
tumours express PD-L1 on at least 1% of tumour cells and whose
disease has not progressed following platinum-based chemoradiation
therapy (CRT).
Lung cancer is the leading cause of cancer death and 80-85% of
patients with lung cancer have NSCLC.(1-3) Approximately one third
of patients are diagnosed in the Stage III setting and the majority
of these have unresectable tumours and are treated with curative
intent.(3-5)
This new dosing option is consistent with the approved Imfinzi
dosing in extensive-stage small cell lung cancer (ES-SCLC) and is
available to patients with locally advanced, unresectable NSCLC
weighing more than 30kg.
The approval by the European Commission was based on data from
several Imfinzi clinical trials. These include the PACIFIC Phase
III trial which supported the two-week, weight-based dosing of
10mg/kg already approved in locally advanced, unresectable NSCLC,
and the CASPIAN Phase III trial which used four-week, fixed dosing
during maintenance treatment in ES-SCLC.
The approval follows an accelerated assessment by the Committee
for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency, which recommended approval in December 2020. This
CHMP recommendation and approval also apply to the UK.
Luis Paz-Ares, MD, PhD, Chair, Medical Oncology Department,
Hospital Universitario Doce de Octubre, Madrid, Spain and principal
investigator in the CASPIAN Phase III trial, said: "Less-frequent
dosing is important for cancer patients, and may be particularly
relevant right now for those suffering from lung cancer, who are
especially vulnerable to complications from COVID-19. Patients with
cancer should be able to focus on living their lives as much as
possible and doctors can now offer them a more convenient dosing
option that could reduce medical visits by half and help avoid
unnecessary risk of exposure to infection in the healthcare
setting."
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, said: "We are pleased to offer a four-week dosing option to
lung cancer patients in Europe to meet an urgent need and help
enable continuity of care during the pandemic. Cancer won't wait,
and it is our job to provide patients with treatment options that
address the challenges the pandemic poses to their care. "
Imfinzi was also recently approved for unresectable Stage III
NSCLC after CRT in the US for the four-week, fixed-dose regimen.
Imfinzi is approved in the curative-intent setting of unresectable,
Stage III (locally advanced) NSCLC after CRT in the EU, US, Japan,
China and many other countries, based on the PACIFIC Phase III
trial. Additionally, it is approved in the EU, US, Japan and many
other countries around the world for the treatment of ES-SCLC based
on the CASPIAN Phase III trial.
Stage III NSCLC
Stage III (locally advanced) NSCLC is commonly divided into
three subcategories (IIIA, IIIB and IIIC), defined by how much the
cancer has spread locally and the possibility of surgery. (2) Stage
III disease is different from Stage IV disease, when the cancer has
spread (metastasised), as the majority of Stage III patients are
currently treated with curative intent. (2,3)
Stage III NSCLC represents approximately one third of NSCLC
incidence and in 2015 was estimated to affect nearly 200,000
patients in China, France, Germany, Italy, Japan, Spain, UK, and
the US, with approximately 43,000 cases in the US alone. (4,6) The
majority of Stage III NSCLC patients are diagnosed with
unresectable tumours. (5) Prior to approval of Imfinzi in this
setting, no new treatments beyond CRT had been available to
patients for decades. (7-9)
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 and several other countries.
As part of a broad development programme, Imfinzi is being
tested as a monotherapy and in combinations including 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,
oesophageal cancer, gastric and gastroesophageal cancer, cervical
cancer, ovarian cancer, endometrial cancer and other solid
tumours.
AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and
potential new medicines in late-stage development for the treatment
of different forms of lung cancer spanning different histologies,
several stages of disease, lines of therapy and modes of
action.
An extensive Immuno-Oncology (IO) development programme focuses
on lung cancer patients without a targetable genetic mutation which
represents up to three-quarters of all patients with lung cancer.
(10) Imfinzi, an anti-PDL1 antibody, is in development for patients
with advanced disease (POSEIDON and PEARL Phase III trials) and for
patients in earlier stages of disease including
potentially-curative settings (MERMAID-1, MERMAID-2, AEGEAN,
ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC Phase
III trials) both as monotherapy and in combination with
tremelimumab and/or chemotherapy.
Imfinzi is also in development in the NeoCOAST, COAST and HUDSON
Phase II trials in combination with potential new medicines from
the early-stage pipeline including Enhertu (trastuzumab
deruxtecan).
AstraZeneca in immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate
the body's immune system to attack tumours. The Company's IO
portfolio is anchored in immunotherapies that have been designed to
overcome anti-tumour immune suppression. AstraZeneca is invested in
using IO approaches that deliver long-term survival for new groups
of patients across tumour types.
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, and where relevant 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 the 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.
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 seven
new medicines 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.
By harnessing the power of six scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage
Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies
- 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.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) 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
& 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 and
follow the Company on Twitter @ AstraZeneca
Contacts
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please click here . For Media contacts, click here .
References
1. World Health Organization. International Agency for Research
on Cancer. Lung Fact Sheet. Available at
http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf
. Accessed January 2021.
2. ASCO. Cancer.net. Lung Cancer - Non-Small Cell. Available at:
https://www.cancer.net/cancer-types/lung-cancer/view-all . Accessed
January 2021.
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. Antonia SJ, et al. PACIFIC Investigators. Durvalumab After
Chemoradiotherapy In Stage III Non-Small-Cell Lung Cancer. N Engl J
Med. 2017;377(20):1919-1929.
5. Provencio M, et al. Inoperable Stage III Non-Small Cell Lung
Cancer: Current Treatment And Role Of Vinorelbine. J Thorac Dis.
2011;3:197-204.
6. EpiCast Report: NSCLC Epidemiology Forecast to 2025.
GlobalData. 2016.
7. Curran WJ, et al. Sequential vs Concurrent Chemoradiation for
Stage III Non-Small Cell Lung Cancer: Randomized Phase III Trial
RTOG 9410. J Natl Cancer Inst. 2011;103(19):1452-1460.
8. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines) - Non-Small Cell Lung Cancer. Version 2.2021.
https://www.nccn.org/professionals/physician_gls/pdf/nscl_blocks.pdf
. Accessed January 2021.
9. Hanna N, et al. Current Standards and Clinical Trials in
Systemic Therapy for Stage III Lung Cancer: What is New? Am Soc
Clin Oncol Educ Book. 2015:e442-447.
10. 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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