TIDMAZN
RNS Number : 6395W
AstraZeneca PLC
12 December 2019
12 December 2019 07:00 GMT
Imfinzi approved in China for the treatment of unresectable,
Stage III
non-small cell lung cancer based on the Phase III PACIFIC
trial
Imfinzi is the only immunotherapy approved in China to treat
patients
in the curative-intent Stage III setting following
chemoradiation treatment
AstraZeneca today announced that it has received marketing
authorisation from China's National Medical Products Administration
(NMPA) for Imfinzi (durvalumab) for the treatment of patients with
unresectable, Stage III non-small cell lung cancer (NSCLC) whose
disease has not progressed following concurrent platinum-based
chemotherapy and radiation therapy (CRT).
The approval of Imfinzi is based on results from the primary
analysis of progression-free survival (PFS) and supported by
overall survival (OS) from the Phase III PACIFIC trial, both
published in The New England Journal of Medicine. A post-hoc
analysis of three-year OS results has since shown that consistent
efficacy was maintained for treatment with Imfinzi after additional
follow up.(1)
Dave Fredrickson, Executive Vice President, Oncology Business
Unit said: "This approval illustrates our long-standing commitment
to improving health outcomes in China, where more than one-third of
the world's lung cancer diagnoses and deaths occur. As the global
standard of care in this curative-intent setting, Imfinzi is an
important new option for patients in China."
Results demonstrated a statistically significant and clinically
meaningful OS and PFS benefit for treatment with Imfinzi vs.
placebo after concurrent CRT. Imfinzi reduced the risk of death by
32% (equal to a hazard ratio of 0.68) and prolonged the time
patients lived without disease progression or death by more than 11
months (median PFS: 16.8 vs. 5.6 months; hazard ratio of 0.52).
Phase III PACIFIC trial primary endpoints
Imfinzi Placebo
(n=476) (n=237)
OS (primary endpoint)(i)
--------------------------------
Number of deaths (%) 183 (38.4%) 116 (48.9%)
--------------- ---------------
Hazard ratio (95% CI)(ii) 0.68 (0.53, 0.87)
--------------------------------
p-value(ii,iii) 0.0025
--------------------------------
Median in months (95% CI) NR(4) 28.7
(34.7, NR)(iv) (22.9, NR)(iv)
--------------- ---------------
PFS (primary endpoint)(v)
--------------------------------
Number of events (%) 214 (45%) 157 (66%)
--------------- ---------------
Hazard ratio (95% CI)(ii,vi) 0.52 (0.42, 0.65)
--------------------------------
p-value(ii,vii) <0.0001
--------------------------------
Median in months (95% CI) 16.8 5.6
(13.0, 18.1) (4.6, 7.8)
--------------- ---------------
(i) OS results are based on the interim OS analysis with a data
cut-off date of 22 March 2018.
(ii) Stratified by sex, age, and smoking history.
(iii) Criteria for statistical significance at the interim
analysis of OS was a p-value <= 0.00274 (using Lan DeMets
spending function approximating O'Brien Fleming boundary).
(iv) Not reached (NR).
(v) Assessed by blinded independent central review (BICR)
according to RECIST v1.1.
(vi) PFS results are based on the interim PFS analysis with a
data cut-off date of 13 February 2017.
(vii) Criteria for statistical significance at the interim
analysis of PFS was a p-value <= 0.011035 (using Lan DeMets
spending function approximating O'Brien Fleming boundary).
Among patients treated with Imfinzi, the most common adverse
reactions (greater than or equal to 20% of patients) were cough,
fatigue, pneumonitis or radiation pneumonitis, upper respiratory
tract infections, dyspnoea, and rash. Serious adverse reactions
occurred in 29% of patients treated with Imfinzi, and 15% of
patients discontinued treatment due to adverse reactions.
Imfinzi is approved in the curative-intent setting of
unresectable, Stage III NSCLC after CRT in 54 countries and
regions, including the US, Japan and across the EU, based on the
Phase III PACIFIC trial. The PACIFIC regimen, CRT followed by
Imfinzi, is the global standard of care for the treatment of
unresectable Stage III NSCLC.
About PACIFIC
The PACIFIC trial was a Phase III, randomised, double-blinded,
placebo-controlled, multi-centre trial of Imfinzi as treatment in
'all-comer' patients (i.e. regardless of PD-L1 status) with
unresectable, Stage III (locally advanced) NSCLC whose disease had
not progressed following concurrent platinum-based CRT.
The trial was conducted at 235 centres across 26 countries
involving 713 patients. The primary endpoints of the trial were PFS
and OS, and secondary endpoints included landmark PFS and OS,
objective response rate, and duration of response.
About Stage III NSCLC
Stage III (locally advanced) NSCLC is commonly divided into
three sub-categories (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 throughout the body (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 the following eight key countries: China, France,
Germany, Italy, Japan, Spain, UK, US.(4,5) The majority of Stage
III NSCLC patients are diagnosed with unresectable tumours.(6)
Prior to approval of Imfinzi in this setting, no new treatments
beyond CRT had been available to patients for decades.(7-10)
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, small cell lung cancer, 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.(11-13)
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.(14) 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 clear 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 (LSE/STO/NYSE: 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 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.
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References
1. Gray JE, et al. Brief Report: Three-year Overall Survival
with Durvalumab after Chemoradiotherapy in Stage III NSCLC - Update
from PACIFIC. Journal of Thoracic Oncology. 2019
doi:10.1016/j.jtho.2019.10.002. Accessed December 2019.
2. ASCO. Cancer.net. Lung Cancer - Non-Small Cell. Available at:
https://www.cancer.net/cancer-types/lung-cancer/view-all. Accessed
December 2019.
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. doi:10.3747/co.25.4096. Accessed
December 2019.
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. EpiCast Report: NSCLC Epidemiology Forecast to 2025.
GlobalData. 2016. Accessed December 2019.
6. 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. Accessed December 2019.
7. Eberhardt WE, et al. Panel Members. 2nd ESMO Consensus
Conference in Lung Cancer: locally advanced Stage III
non-small-cell lung cancer. Ann Oncol. 2015;26(8):1573-1588.
Accessed December 2019.
8. Gandara DR, et al. Long-Term Survival with Concurrent CRT
Followed by Consolidation Docetaxel in Stage IIIB Non-Small-Cell
Lung Cancer: A Phase II Southwest Oncology Group Study (S9504).
Clin Lung Cancer. 2006;8(2):116-121. Accessed December 2019.
9. Hanna N. 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. Accessed December 2019.
10. NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines). Non-small cell lung cancer, version 8. 2017.
https://www.nccn.org/professionals/physician_gls/pdf/nscl_blocks.pdf.
Published August 3, 2017. Accessed December 2019.
11. 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.
12. 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.
13. 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.
14. 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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