FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of May
2022
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi combo granted Priority Review for BTC
4 May 2022 07:00 BST
Imfinzi plus
chemotherapy granted Priority Review in the US for
patients
with locally advanced or metastatic biliary tract
cancer
based on TOPAZ-1 Phase III trial
First Phase III trial in this setting to show improved overall
survival with an
immunotherapy added to chemotherapy over
standard-of-care chemotherapy alone
AstraZeneca's supplemental Biologics
License Application (sBLA) for Imfinzi (durvalumab), in combination with
standard-of-care chemotherapy, has been accepted and granted
Priority Review in the US for patients with locally advanced or
metastatic biliary tract cancer (BTC).
The Food and Drug Administration (FDA) grants Priority Review to
applications for medicines that, if approved, would offer
significant improvements over available options by demonstrating
safety or efficacy improvements, preventing serious conditions, or
enhancing patient compliance.1 The
Prescription Drug User Fee Act date, the FDA action date for their
regulatory decision, is during the third quarter of
2022.
BTC is a group of rare and aggressive cancers that occur in the
bile ducts and gallbladder. 2,3 Approximately
23,000 people in the US are diagnosed with BTC each
year.2 These
patients have a poor prognosis, with approximately 5% to 15% of
patients with BTC surviving five years.4
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "People with advanced biliary tract cancer have
faced poor outcomes and limited treatment options for too long, and
today's news for the TOPAZ-1 trial underscores the urgency to
deliver new, effective therapies in this setting. We are working
closely with the FDA to bring the first immunotherapy-based option
to patients with this devastating cancer and potentially set a new
standard of care with Imfinzi plus chemotherapy."
The sBLA was based on results from an interim analysis of the
TOPAZ-1 Phase III trial presented during
the 2022 American Society of Clinical Oncology Gastrointestinal
Cancers (ASCO GI) Symposium. The data
showed Imfinzi plus chemotherapy (gemcitabine plus
cisplatin) reduced the risk of death by 20% versus chemotherapy
alone (based on a hazard ratio [HR] of 0.80; 95% confidence
interval [CI], 0.66-0.97; 2-sided p=0.021). An estimated one in
four (25%) patients treated with Imfinzi plus chemotherapy were alive at two years
compared to one in 10 (10%) treated with chemotherapy
alone.
Results also showed a statistically significant 25% reduction in
the risk of disease progression or death
with Imfinzi plus chemotherapy (HR, 0.75; 95% CI,
0.64-0.89; 2-sided p=0.001). The Imfinzi combination
was generally well tolerated and did not increase the
discontinuation rate due to adverse events compared to chemotherapy
alone.
In December 2020, Imfinzi was granted Orphan Drug Designation in the
US for the treatment of BTC.
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).2,3
Cholangiocarcinoma is more common in China and South-East Asia and
is on the rise in Western countries.2,4 Gallbladder
cancer is more common in certain regions of South America, India
and Japan.5
Early-stage BTC affecting the bile ducts and gallbladder often
presents without clear symptoms and most new cases of BTC are
therefore diagnosed at an advanced stage, when treatment options
are limited and the prognosis is poor.4-6
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. Patients
with ampullary carcinoma were excluded.
The primary endpoint is overall survival and key secondary
endpoints included progression-free survival, objective response
rate and safety. The trial was conducted in 105 centres across 17
countries including in the US, Europe, South America and several
countries in Asia including South Korea, Thailand, Japan and
China.
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.
Imfinzi 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 chemoradiotherapy,
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. In 2021,
updated results from the CASPIAN trial
showed Imfinzi plus chemotherapy tripled patient survival
at three years versus chemotherapy alone.
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
small cell lung cancer (SCLC), NSCLC, bladder cancer, several GI
cancers, ovarian cancer, endometrial cancer, and other solid
tumours.
In the past year, Imfinzi combinations have demonstrated clinical
benefit in multiple additional cancer settings with positive Phase
III trials in unresectable advanced liver cancer (HIMALAYA) and
metastatic NSCLC (POSEIDON).
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.6
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.
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 evasion of
the anti-tumour immune response. 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, and 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
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. FDA. Priority Review. Available
at:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review.
Accessed May 2022.
2. Marcano-Bonilla L, et al. Biliary tract cancers: epidemiology,
molecular pathogenesis and genetic risk
associations. CCO. 2016;5(5).
3. ESMO. What is Biliary Tract Cancer. Available
at:https://www.esmo.org/content/download/266801/5310983/1/EN-Biliary-Tract-Cancer-Guide-for-Patients.pdf.
Accessed May 2022.
4. Turkes F, et al. Contemporary Tailored Oncology Treatment of
Biliary Tract Cancers. Gastroenterol Res
Pract. 2019;
2019:7698786.
5. Rawla P, et al. Epidemiology of gallbladder
cancer. Clin Exp
Hepatol.
2019;5(2):93-102.
6. Banales
JM, et
al. Cholangiocarcinoma 2020:
the next horizon in mechanisms and
management. Nat Rev
Gastroenterol Hepatol.
2020;17:557-588.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
04 May 2022
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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