TIDMAZN
RNS Number : 1081Q
AstraZeneca PLC
25 October 2021
25 October 2021 7:00 BST
Imfinzi plus chemotherapy significantly improved overall
survival in 1st-line advanced biliary tract cancer in TOPAZ-1 Phase
III trial at interim analysis
First immunotherapy combination to demonstrate superior clinical
outcomes
over standard of care in a global, randomised trial in this
setting
Positive high-level results from the TOPAZ-1 Phase III trial
showed Imfinzi (durvalumab), in combination with standard-of-care
chemotherapy, demonstrated a statistically significant and
clinically meaningful overall survival (OS) benefit versus
chemotherapy alone as a 1st-line treatment for patients with
advanced biliary tract cancer (BTC ).
At a predefined interim analysis, the Independent Data
Monitoring Committee concluded that the trial met the primary
endpoint by demonstrating an improvement in OS in patients treated
with Imfinzi plus chemotherapy versus chemotherapy alone. The
combination also demonstrated an improvement in progression-free
survival (PFS) and overall response rate, key secondary
endpoints.
Imfinzi plus chemotherapy was well tolerated, had a similar
safety profile versus the comparator arm and did not increase the
discontinuation rate due to adverse events compared to chemotherapy
alone.
BTC is a group of rare and aggressive cancers that occur in the
bile ducts and gallbladder.(1,2) Incidence of BTC often depends on
the prevalence of common risk factors for each type within a
geographical region.
Approximately 50,000 people in the US, Europe and Japan and
about 210,000 people worldwide are diagnosed with BTC each
year.(3-5) These patients have a poor prognosis, with approximately
only 5% to 15% of all patients with BTC surviving five years.(4) In
December 2020, Imfinzi was granted Orphan Drug Designation in the
US for the treatment of BTC.
Do-Youn Oh, MD, PhD, Professor, Division of Medical Oncology,
Department of Internal Medicine at Seoul National University
Hospital and Seoul National University College of Medicine, and
principal investigator in the TOPAZ-1 Phase III trial, said: "
Patients with advanced biliary tract cancer are in dire need of new
treatments as progress in the 1st-line setting has remained largely
stagnant for more than 10 years. TOPAZ-1 is the first Phase III
trial to show that adding an immunotherapy to standard chemotherapy
delivers a meaningful overall survival benefit for patients in this
setting. Today's exciting results are a major step forward in
treating this disease and represent new hope for our patients."
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "We are delighted TOPAZ-1 has been unblinded
early due to clear evidence of efficacy for Imfinzi plus
chemotherapy, which has also demonstrated a strong safety profile.
We have now delivered two positive gastrointestinal cancer trials
in a row for Imfinzi, following the HIMALAYA trial in liver cancer.
We believe the significant survival benefit demonstrated marks a
new era of immunotherapy treatment in this devastating disease, and
it advances our commitment to improving long-term survival for
patients across these cancers where treatment options are
limited."
The data will be presented at a forthcoming medical meeting and
shared with health authorities.
Notes
Biliary tract cancer
Biliary tract cancer (BTC) is a group of rare and aggressive
gastrointestinal ( GI) cancers that form in the cells of the bile
ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where
the bile duct and pancreatic duct connect to the small
intestine).(1,2) Cholangiocarcinoma is more common in China and
Thailand and is on the rise in Western countries.(8-10) Gallbladder
cancer is more common in certain regions of South America, India
and Japan.(11,12)
Apart from ampullary cancer, early-stage BTC often presents
without symptoms and most new cases of BTC are therefore diagnosed
at an advanced stage, when treatment options are limited and the
prognosis is poor.(13,14)
TOPAZ -1
TOPAZ-1 is a randomised, double-blind, placebo controlled,
multicentre, global Phase III trial of Imfinzi in combination with
chemotherapy (gemcitabine plus cisplatin) versus placebo in
combination with chemotherapy as a 1st-line treatment in 685
patients with unresectable advanced or metastatic BTC including
intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder
cancer (ampullary carcinoma was excluded).
The trial is being conducted in more than 145 centres across 17
countries including in the US, Europe, South America and several
countries in Asia including South Korea, Thailand, Japan, Taiwan
and China. The primary endpoint is OS and key secondary endpoints
include progression-free survival, objective response rate and
safety.
Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds
to the PD-L1 protein and blocks the interaction of PD-L1 with the
PD-1 and CD80 proteins, countering the tumour's immune-evading
tactics and releasing the inhibition of immune responses.
I mfinzi is the only approved immunotherapy in the
curative-intent setting of unresectable, Stage III non-small cell
lung cancer (NSCLC) in patients whose disease has not progressed
after chemoradiation therapy and is the global standard of care in
this setting based on the PACIFIC Phase III trial.
Imfinzi is also approved in the US, EU, Japan, China and many
other countries around the world for the treatment of
extensive-stage small cell lung cancer (ES-SCLC) based on the
CASPIAN Phase III trial.
Imfinzi is also 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 SCLC, NSCLC, bladder
cancer, liver cancer, BTC, oesophageal cancer, gastric and
gastroesophageal cancer, cervical cancer, ovarian cancer,
endometrial cancer, and other solid tumours.
AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment
of GI cancers across several medicines and a variety of tumour
types and stages of disease. In 2020, GI cancers collectively
represented approximately 5.1 million new cancer cases leading to
approximately 3.6 million deaths.(15)
Within this programme, the Company is committed to improving
outcomes in gastric, liver, BTC, oesophageal, pancreatic, and
colorectal cancers.
Imfinzi is being assessed in combinations in liver, BTC,
oesophageal and gastric cancers in an extensive development
programme spanning early to late-stage disease. In October 2021,
the HIMALAYA Phase III trial in 1st-line unresectable liver cancer
met its primary endpoint of overall survival with the STRIDE
regimen, a single, high priming dose of tremelimumab plus Imfinzi
every four weeks versus sorafenib.
The Company aims to understand the potential of Enhertu
(trastuzumab deruxtecan), a HER2-directed antibody drug conjugate,
in the two most common GI cancers, colorectal and gastric cancers.
Enhertu is jointly developed and commercialised by AstraZeneca and
Daiichi Sankyo.
Lynparza (olaparib) is a first-in-class PARP inhibitor with a
broad and advanced clinical trial programme across multiple GI
tumour types including pancreatic and colorectal cancers. Lynparza
is developed and commercialised in collaboration with MSD (Merck
& Co., Inc. inside the US and Canada).
AstraZeneca in immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate
the body's immune system to attack tumours. The Company's
Immuno-Oncology (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, targeted small 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, Rare Diseases, 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
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3. Siegel RL, Cancer statistics, 2020. CA Cancer J Clin 2020;70:7-30.
4. ECIS - European Cancer Information System. Available here . Accessed October 2021.
5. Kohei Nakachi, et al. Hepatobiliary and Pancreatic Oncology
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biliary tract cancer: Japan Clinical Oncology Group Study
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China. World J Gastroenterol. 2014; 20(28): 9541-9548.
15. WHO. World Cancer Fact Sheet. Available here . Accessed
October 2021.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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