TIDMAZN
RNS Number : 5859F
AstraZeneca PLC
19 July 2021
19 July 2021 07:00 BST
Imfinzi approved in China for the treatment
of extensive-stage small cell lung cancer
Only PD-1/PD-L1 immunotherapy to demonstrate both a significant
survival benefit and improved response rate in combination with a
choice of chemotherapies
AstraZeneca's Imfinzi (durvalumab) has been approved in China
for the 1st-line treatment of adult patients with extensive-stage
small cell lung cancer (ES-SCLC), in combination with standard of
care platinum chemotherapy (etoposide plus a choice of either
carboplatin or cisplatin).
The approval by China's National Medical Products Administration
was based on positive results from the CASPIAN Phase III trial. The
trial showed that Imfinzi plus chemotherapy demonstrated a
statistically significant and clinically meaningful improvement in
overall survival (OS) versus chemotherapy alone. In addition,
results from the China cohort of patients were consistent with the
global results.
Small cell lung cancer (SCLC) is a highly aggressive,
fast-growing form of lung cancer that typically recurs and
progresses rapidly despite initial response to chemotherapy.(1,2)
Prognosis is particularly poor, as only 7% of all SCLC patients and
3% of those with extensive-stage disease will be alive five years
after diagnosis.(3)
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, said: "Today's approval of Imfinzi plus chemotherapy brings
an important global standard of care to patients with
extensive-stage small cell lung cancer in China, who have had few
treatment options and a dire prognosis. Physicians can now offer
these patients a well-tolerated immunotherapy regimen with
sustained overall survival and prolonged treatment response, as
well as convenient dosing. This is also the first time physicians
have had the choice to combine immunotherapy with cisplatin, a
preferred chemotherapy in this setting in China."
The CASPIAN Phase III trial met the primary endpoint of OS for
Imfinzi plus chemotherapy in June 2019, reducing the risk of death
by 27% versus chemotherapy alone (based on a hazard ratio [HR] of
0.73; 95% confidence interval [CI] 0.59-0.91; p=0.0047), with a
median OS of 13.0 months versus 10.3 months for chemotherapy alone.
These results were published in The Lancet in October 2019.(4)
Results also showed an increased confirmed objective response rate
for Imfinzi plus chemotherapy (68% versus 58% for chemotherapy
alone). Imfinzi added to chemotherapy delayed the time for disease
symptoms to worsen.(4)
An updated analysis showed sustained efficacy for Imfinzi plus
chemotherapy after a median follow up of more than two years (OS HR
of 0.75; 95% CI 0.62-0.91; nominal p=0.0032), with median OS of
12.9 months versus 10.5 months for chemotherapy alone. An estimated
22.2% of patients treated with Imfinzi plus chemotherapy were alive
at 24 months versus 14.4% for chemotherapy alone . The safety and
tolerability for Imfinzi and chemotherapy were consistent with the
known safety profiles of these medicines. No patients tested
positive for treatment-emergent anti-drug antibodies to
Imfinzi.
Safety and efficacy results in the China cohort of patients were
consistent with results in the overall global trial population.
Detailed results from this cohort will be presented at a
forthcoming medical meeting.
The CASPIAN Phase III trial used a fixed dose of Imfinzi
(1500mg) administered every three weeks for four cycles while in
combination with chemotherapy and then every four weeks as a
monotherapy until disease progression. Based on the trial results,
Imfinzi, in combination with etoposide and either carboplatin or
cisplatin, is approved in the 1st-line setting of ES-SCLC in more
than 55 countries, including the US, Japan and across the EU.
Imfinzi is also being tested following concurrent chemoradiation
therapy in patients with limited-stage SCLC in the ADRIATIC Phase
III trial as part of a broad development programme. In addition,
Imfinzi is also approved to treat non-small cell lung cancer
(NSCLC) in the curative-intent setting of unresectable, Stage III
disease after chemoradiation therapy in the US, Japan, China,
across the EU and in many other countries, based on results from
the PACIFIC Phase III trial.
Small cell lung cancer
Lung cancer is the leading cause of cancer death among men and
women and accounts for about one-fifth of all cancer deaths.(5)
Lung cancer is broadly split into NSCLC and SCLC, with about 15%
classified as SCLC.(6) 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)
CASPIAN
CASPIAN was a randomised, open-label, multi-centre, global Phase
III trial in the 1st-line treatment of 805 patients with ES-SCLC.
The trial compared Imfinzi in combination with etoposide and either
carboplatin or cisplatin platinum chemotherapy, or Imfinzi and
chemotherapy with the addition of a second immunotherapy,
tremelimumab, versus chemotherapy alone. In the two experimental
arms, patients were treated with four cycles of chemotherapy. In
comparison, the control arm allowed up to six cycles of
chemotherapy and optional prophylactic cranial irradiation.
The trial was conducted in more than 200 centres across 23
countries, including the US, Europe, South America, Asia and the
Middle East. The primary endpoint was OS in each of the two
experimental arms. In June 2019, AstraZeneca announced the CASPIAN
Phase III trial had met one primary endpoint of demonstrating OS
for Imfinzi plus chemotherapy at a planned interim analysis. In
March 2020, however, it was announced that the second experimental
arm with tremelimumab did not meet its primary endpoint of OS.
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.
In addition to approvals in ES-SCLC and unresectable, Stage III
NSCLC, Imfinzi is approved for previously treated patients with
advanced bladder cancer in several countries. Since the first
approval in May 2017, more than 100,000 patients have been treated
with Imfinzi.
As part of a broad development programme, Imfinzi is being
tested as a single treatment and in combinations with other
anti-cancer treatments for patients with NSCLC, SCLC, bladder
cancer, hepatocellular carcinoma, biliary tract cancer (a form of
liver cancer), oesophageal cancer, gastric and gastroesophageal
cancer, cervical cancer, ovarian cancer, endometrial cancer, and
other solid tumours.
AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer
to cure through the detection and treatment of early-stage disease,
while also pushing the boundaries of science to improve outcomes in
the resistant and advanced settings. By defining new therapeutic
targets and investigating innovative approaches, the Company aims
to match medicines to the patients who can benefit most.
The Company's comprehensive portfolio includes leading lung
cancer medicines and the next wave of innovations, including
Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi (durvalumab)
and tremelimumab; Enhertu (trastuzumab deruxtecan) and datopotamab
deruxtecan in collaboration with Daiichi Sankyo; Orpathys
(savolitinib) in collaboration with HUTCHMED; as well as a pipeline
of potential new medicines and combinations across diverse
mechanisms of action.
AstraZeneca is a founding member of the Lung Ambition Alliance,
a global coalition working to accelerate innovation and deliver
meaningful improvements for people with lung cancer, including and
beyond treatment.
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 single treatment and in combination with
tremelimumab and other novel antibodies in multiple tumour types,
stages of disease, and lines of treatment, 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 is leading a revolution in oncology with the
ambition to provide cures for cancer in every form, following the
science to understand cancer and all its complexities to discover,
develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers.
It is through persistent innovation that AstraZeneca has built one
of the most diverse portfolios and pipelines in the industry, with
the potential to catalyse changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care 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 in
Oncology and BioPharmaceuticals, including 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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References
1. National Cancer Institute. NCI Dictionary - Small Cell Lung Cancer. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer . Accessed July 2021.
2. Kalemkerian GP, et al. Treatment Options for Relapsed
Small-Cell Lung Cancer: What Progress Have We Made? J Oncol Pract,
2018:14;369-370.
3. Cancer.Net. Lung Cancer - Small Cell. Available at
https://www.cancer.net/cancer-types/33776/view-all . Accessed July
2021 .
4. Paz-Ares L, et al. Durvalumab plus platinum-etoposide versus
platinum-etoposide in first-line treatment of extensive-stage small
cell lung cancer (CASPIAN): a randomised, controlled, open-label,
Phase III trial. The Lancet. 2019;394(10212):1929-1939.
5. 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 July 2021.
6. LUNGevity Foundation. Types of Lung Cancer. Available at https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer . Accessed July 2021.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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